January 2009 VOL.

1 ISSUE 4

BIO OUTSOURCING ASIA
Biopharmaceutical Outsourcing Opportunities and Challenges

Business in
Making strides in the biotechnology sector

A Supportive National Biotechnology Policy

BioNexus
Applying for BioNexus Status in Malaysia

Bio Outsourcing Asia© TABLE OF CONTENTS January 2009 Vol. 1 Issue 4 © CanBiotech Inc.

MALAYSIA
Page 4 Malaysia: Emerging Biotechnology Hub Page 10 Crafting a National Biotechnology Policy Page 13 The BioNexus Network Page 15 BioNexus Companies in Malaysia Page 18 A Malaysian Entrepreneur Development Framework

INDUSTRY UPDATE

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Page 21 Safety Reporting-Global Issues Guest Authors: Dr. Izabela Slowik PharmaVigilance Consulting Group, Warsaw & Dr. Anjali Shukla Accure Labs Pvt. Ltd., India

INDUSTRY NEWS
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Malaysia: Emerging Biotechnology Hub
Biotechnology has been identified as a key driver of growth for Malaysia. The country hopes to establish itself as a knowledge economy by the year 2020. Consequently, biotechnology is seen as augmenting Malaysia’s current sectors such as plantations and manufacturing, as well as seen as advancing new sectors such as traditional medicines and agriculture. (www.binasia.net) Malaysia—one of 12 countries in the world endowed with rich diversity, appears to have all of the key elements for a successful biotechnology industry including a supportive government. The Government has identified biotechnology as the next engine of economic growth for the country. Consequently, biotechnology has received strong governmental support—with a commitment for research and development (R&D). (www.binasia.net) The biotechnology industry is expected to generate RM270 billion in revenue for the country by 2020. The sector’s contribution is expected to be approximately 2.5 % by 2010, 4.0% by 2015 and 5.0% by 2020. It is further estimated that the sector will have created 280,000 new jobs by 2020 with 100 biotechnology companies established in Malaysia over the next 15 years. (www.bioasianetpacific.com) National Biotechnology Policy As in the case for other Asian countries, government policy has served as the primary driver for the development of biotechnology industry. Starting in the mid-1990s, the Malaysian government launched a series of biotechnology initiatives, known as the National Biotechnology Policy, to strengthen the scientific infrastructure, promote commercialization, and provide investment capital. The lead government agency for biotechnology is the Ministry of Science, Technology, and Environment (MOSTE), which established the National Biotechnology Directorate (Biotek). (Yuan, 2007) Biotek has organized biotechnology R&D into seven sectors: molecular biology, plant, animal, medical, biopharmacy, food, and environmental. (Yuan, 2007) Similarly, the Malaysian Biotechnology Corporation (MBC; BiotechCorp) is the lead agency for developing the biotechnology industry. BiotechCorp is an agency under the purview of Ministry of Science, Technology and Innovation and is wholly-owned by the Ministry of Finance Incorporated. BiotechCorp is governed by the Biotechnology Implementation Council and advised by the Biotechnology International Advisory Panel, both chaired by the honourable Prime Minister of Malaysia, YAB Dato’ Seri Abdullah Bin Haji Ahmad Badawi. (www.biotechcorp.com.my) BiotechCorp acts as a central contact point providing support, facilitation and advisory services for life sciences companies, in Malaysia. To date, BiotechCorp has facilitated the development of 71 BioNexus-status companies in Malaysia, with total approved investment of US$400 million (RM1.3 billion). (www.biotechcorp.com.my) R&D Capacity The Malaysian government also has three major initiatives to increase R&D capacity, develop bio-

technology based human capital, and stimulate commercialization. The Malaysia-MIT Biotechnology Partnership Program for example is a research collaboration—bringing together 200 researchers in Malaysian institutes and 27 researchers at MIT. The research collaboration is a five-year plan that focuses on medicinal plants and palm oil R&D. (Yuan, 2007)

ties, MTDC has evolved to become a venture capital outfit and has been the leading venture capitalist in the country long before the concept became familiar and accepted in Malaysia. (www.biotechcorp.com.my)

The Malaysian Life Sciences Capital Fund (MLSCF) was founded in late 2006 and is a life sciences venture fund specializing in early stage Another initiative is a $6.7 million program estab- investments in the areas of agriculture, industrial, lished at the California Institute for Quantitative and healthcare biotechnology. Co-managed by Biomedical Research (QB3), which is a consorMalaysian Technology Development Corporation tium of the University of California San Francisco Sdn Bhd (MTDC) and Burrill & Co., the fund has (UCSF), UC Berkeley, UC Santa Cruz, and biotech USD140-150 million in committed capital. companies. (Yuan, 2007) (www.biotechcorp.com.my) The program includes visits by Malaysian scientists and administrators for the purposes of being training in advanced skills and also for participation in UCSF’s Center for Bioentrepreneurship. The initiative further provides opportunities for students to conduct their Ph.D. thesis work or postdoctoral research in California. (Yuan, 2007) The third initiative, The Malaysian Life Science Capital Fund, expects to raise $200 million and will be jointly managed by Malaysian Technology Development and Burrill & Co. The plans are to use $140 million for investment into some 20 companies with an average outlay of $7 million. The balance of the funds will be invested in the Burrill Life Science Capital Fund. (Yuan, 2007) Malaysia Debt Ventures Berhad (MDV) was incorporated in 2002 and is a wholly owned subsidiary of the Minister of Finance, Inc. MDV has been entrusted to manage funds of RM2.5 billion for the financing of projects in several industry sectors including biotechnology. MDV provides financing amounts up to RM120million. (www.biotechcorp.com.my)

The SME Bank—or Bank Perusahaan Kecil & Sederhana Malaysia Berhad—evolved into a development financial institution in 2005 to meet the unique needs of small and medium enterprises (SMEs). As a one-stop financial centre responding to the funding and business growth needs of Malaysian SMEs, the Bank complements existing products and services offered by commercial BioNexus banks through a set of comprehensive and integrated financial and business advisory services. BioNexus Malaysia is essentially a network of cen- The bank offers a dedicated biotechnology protres of excellence throughout the country— com- gramme. (www.biotechcorp.com.my) prising companies and institutions that specialize in specific biotech subsectors. (www.binasia.net) In 2004, the Ministry of Science, Technology and Innovations (MOSTI) was formed after the reThree centres of excellence comprise BioNexus: structuring of MOSTE. In supporting the development of biotechnology industry in Malaysia,  The Centre of Excellence for AgroMOSTI provides many funds for biotechnology. biotechnology; (www.biotechcorp.com.my) (See Page 5)  The Centre of Excellence for Genomic & Molecular Biology; Sectors  The Centre of Excellence for Pharmaceuticals & Nutraceuticals. The pharmaceutical market in Malaysia is one of the fastest growing in Asia Pacific region with a These three institutes are part of the BioNexus CAGR of 10.5%. According to Frost & Sullivan initiative whose goal is to coordinate and estimates, the Malaysian pharmaceutical industry strengthen existing universities, laboratories, and was valued at $1,027 million in 2007 and is exresearch institutes. Agricultural biotechnology re- pected to touch $1,800 million by 2013. (Tham search will be done in collaboration with the and Yahya, 2008) Malaysian Agricultural Research and Development Institute (MARDI) and Universiti Putra Malaysia. The key drivers that are anticipated to fuel this Genomics and molecular biology will be coordigrowth are: nated with the Universiti Kebansaan Malaysia, while biomedical work will be located in the Medical tourism: In 2006, about 300,000 foreign BioValley. (Yuan, 2007) patients received medical treatment in the country, generating foreign exchange earnings of more than Another major component of BioNexus is to con- $ 27.63 million. These visits from foreign patients fer special status to selected domestic and foreign are likely to drive the demand for pharmaceutical companies. BioNexus-status companies are inter- products. national and Malaysian biotech companies that qualify for fiscal incentives, grants, and guarantees Market for generic products: The patent expiry of administered by BiotechCorp. blockbuster drugs, coupled with government sup(www.biotechcorp.com.my) port and rising healthcare costs, are likely to drive the demand for generic products. Funding Specialist therapy-driven market: The increased The Malaysian Technology Development Cor- incidence of the top five death-related diseases and the biotechnology industry will drive the deporation (MTDC) was set up by the Government of Malaysia in 1992 to spearhead the mand for specialist therapies. development of technology businesses in Malaysia. Its initial role was to focus on the promotion and commercialization of local research and invest in new ventures aimed at transferring new technologies from abroad. From those investment activi4

FUND
MTDC-Non ICT Venture Fund MTDC-Technology Acquisition Fund (TAF) MTDC-Commercialization of R&D (CRDF) Malaysian Life Sciences Capital Funds (MLSCF) MDV- Equipment & Infrastructure Financing

FUND SIZE AND MAXIMUM PAYOUT (RM)
1 billion; No specific limit, range from RM3 million to RM50 million. 100 million; RM2 million. 115 million; RM4 million or 70% of the project cost. USD 140-150 million; USD 7-8 million.

PURPOSE
Investment in venture capital. Acquisition of foreign technology. Commercialization of local R&D. Investment in early to mid stage companies that are involved in healthcare, industrial, and agricultural biotechnology Finance acquisition and construction of land/building, equipment and fittings for laboratory; and R&D and/or manufacturing facilities, including financing of interest accrued during construction. Funding and assistance to purchase business assets, to meet business expenses, in particular to enable applicants to meet their operating expenses, purchase inventory, receivables financing. Financing of major inputs for projects that are dependent on medium to long-term contracts from sponsors. The facility may also provide for short to long term financing to companies awarded contracts to construct and complete biotechnology infrastructure.

MDV-Working Capital Financing

MDV-Contract/Project Financing

Development of new products or processes up to proof-of-concept; enhancement of research capability. MOSTI-Inno Fund 80 million; Enterprises -RM3,000,000; Commu- To encourage participation from micro ennity groups – RM 1,000,000. trepreneurs. MOSTI-Techno Fund 680 million; Up to a maximum of the total pro- Pre-commercialization support including ject cost or RM5 million whichever is lower. development and up-scaling of new and novel technologies from lab scale prototype up to commercial readiness. MOSTI-Agro-Biotechnology R&D Initiatives 80 million; Up to a maximum of the total proR&D in strategic areas of agro-biotech that ject cost or RM2.5 million whichever is lower. will lead to modernization and transformation of the agricultural sector. MOSTI-Genomic and Molecular Biology R&D Initia- 100 million; Up to a maximum of the total pro- Generation of intellectual property and techtives ject cost or RM5 million whichever is lower. nologies for application in modern biomanufacturing including high value products such as biocatalysts, fine chemicals, and diagnostics. MOSTI-Pharmaceutical and Nutraceutical R&D Initia- 90 million; Up to a maximum of the total proTo develop proof of concept products or tives ject cost or RM5 million whichever is lower. services developed by local scientists to comply with the international standards imposed by the regulatory authorities such as good research practice (GRP) and good laboratory practice (GLP). Increased demand for OTC/food supplements, herbal and traditional products: As the population ages and becomes more proactive with respect to their health, it is anticipated there will be an increased demand for OTC/food supplement products, as well as herbal and traditional medicines. (Tham and Yahya, 2008) However, the Malaysian pharmaceutical industry relies heavily on imported products, which fulfill 70% of demand, with Malaysians placing higher trust in imported brands. This reliance on imported drugs has resulted in intense competition between imported and locally manufactured products. As such, domestic pharmaceutical players are now increasingly looking abroad for growth opportunities. For example, local pharmaceutical companies have been exporting to over 30 countries. Major export destinations for these companies include Singapore, Vietnam, Brunei, Hong Kong, Taiwan, Japan, India, and Germany. With the acceptance of Malaysia in the Pharmaceutical Inspection Cooperation (PIC) Scheme, Malaysian companies are now exporting pharmaceutical products to PIC countries including European Union, Canada and Australia. (Tham and Yahya, 2008) The total export value of drugs from Malaysia stood at $131 million in 2004 and Frost & Sullivan estimates the value to grow at a rate of 5.4% between 2006 and 2103. The biotechnology industry likewise offers opportunities for both domestic and multinational companies. The market capitalization of biotechnology and biotechnology-related healthcare companies listed on the Malaysian Stock Exchange has reached $857 million, with foreign direct investment close to $286 million. (Tham and Yahya, 2008) In terms of biotechnology R&D, the outcomes are visible in the genomics, health, medical diagnostics, animal, food, and environmental biotechnology arenas. Genomics technology is being applied to studies on gene discovery, molecular diagnostics, and gene expression technology involving tropical bio-resources. Successes in medical biotechnology include the commercial production of several diagnostics kits for dengue, several diagnostics kits for other infectious tropical diseases, and a bioenhanced formulation of artemisinin, an anti-malarial drug. Research in animal biotechnology has produced several recombinant vaccines for improved healthcare, applied marker assisted breeding for increased breeding efficiency, and has provided alternative sources of livestock feed. Food biotechnology R&D has yielded several clarified juices and food enhancement products. Research in environmental biotechnology has resulted in the treatment of industrial and agricultural waste through bio-augmentation and genetic engineering of microbes. (www.binasia.net) Malaysia however still needs to focus on certain priorities to improve the position of its biotechnology industry such as increasing the value of its agricultural products, the development of halal pharmaceuticals and food products, and exploiting biodiversity to generate new medicinal products. (Yuan, 2007) Most of Malaysia’s agricultural biotechnology currently revolves around government institutes and large plantations. (Continued on Page 7)
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MOSTI-Science Fund

550 million; RM500,000.

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(Continued from Page 5) Frost & Sullivan predicts that for example, biodiversity will be the key to the future of the high-growth pharmaceutical and biotech industries; Malaysia's biodiversity holds great promise and should therefore be exploited. (Tham and Yahya, 2008)To date however, there are still few partnerships and investments with foreign companies and multinationals, and Malaysia is still short of the scientific and managerial manpower needed to grow its biotechnology industry. (Yuan, 2007) Competitive Outlook How does Malaysia compete against the rest of Asia? Japan, Taiwan, and Korea appear to be ahead of the curve with new start-ups and private entrepreneurial investments. Indonesia is planning a Bio-Island, located on Rempang Island, which was expected to be completed in 2008. Over the next five years, Singapore’s government will be managing around US$700 million to develop Singapore into a biomedical Asian hub. China and India have also attracted strong interest and investment because of their sound base of scientific excellence, cost advantages, and large domestic markets. (www.malaysiamission.com)

UPCOMING EVENTS

New Dates! Drug Discovery and Clinical Development in India Mumbai, India February 25-February 28 2009

Although Malaysia is still lagging behind some Asian countries in terms of techno- This conference will continue to serve as an international logical development and human resources, the Malaysian government has shown and neutral forum to address current solid scientific its determination and interest in catalyzing the biotechnology industry. The comresearch in India pertaining to global development of panies that have already opted to invest in Malaysia have indicated their choice was influenced by readily available bio-resources and the supporting infrastructure drugs and biologics. Global thought leaders and experts for further R&D. As an example, Malaysia—with less red tape in dispensing across the pharmaceutical, academia, and regulatory funds—has already attracted Singapore investors to set up a number of biotech agencies will convene to present drug discovery, global companies. Malaysia is also partnering with multinational companies such as Roche Diagnostics of Switzerland in developing a SARS diagnostic kit. Other for- clinical research, and scientific working groups. Keynote lectures, workshops, and parallel discussion will highlight eign partnerships include such countries as Korea, U.K., Russia, and Japan. (www.malaysiamission.com). (www.malaysiamission.com) the conference. Over the years, biotech research units have been set up in most Malaysian public universities and the private sector has engaged in some biotech R&D—largely focused on plant tissue culture. According to the Economic Report for 2002/2003, some 50 Malaysian companies use biotechnological processes, (primarily in food production, herbal products, and pharmaceuticals) but this still falls short of exploiting the country’s biotechnological potential. With 12,500 species of flowering plants, 1,100 species of ferns, and one of the world’s most diverse coral communities, Malaysia has a very diverse bio-source universe still untapped—potentially serving as sources of treatment for many diseases. (www.malaysiamission.com) With Malaysia’s traditional and herbal market growing at rate of 15 to 20%, according to Frost & Sullivan, demands by local and international consumers should continue to drive the market. (Tham and Yahya, 2008) It is also hoped that as Malaysians turn to an increasingly healthy lifestyle, opportunities should open up to biotechnology, pharmaceutical, and even bio-generics companies alike. It will be up to the key industry stakeholders to take advantage of these opportunities to meet the needs of the Malaysian population.

http://www.diahome.org/

UPCOMING EVENTS

It is hoped that as Malaysians turn to an increasingly healthy lifestyle, opportunities should open up to biotechnology, pharmaceutical and even bio-generics companies alike.

Biotechnology Clinical Trials Outsourcing Burlingame, CA March 20 2009 Successful outsourcing of clinical drug development activities is critical to smaller companies who typically lack the infrastructure and personnel to perform these functions in-house. This one-day conference was designed and the location chosen specifically for smaller companies located on the West Coast. The program will provide highly interactive discussion from sponsor companies and service providers from “both sides of the fence”. Participants can share their insights and experiences and learn how to apply outsourcing concepts and strategies to their own projects and corporate culture. http://www.diahome.org/
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References:
1) 2)

3) 4) 5) 6)

www.binasia.net www.bioasianetpacific.com Yuan, R. (2007) Malaysian Gov't Fosters Biotech Growth. Genetic Engineering and Biotechnology News, Vol. 27(15). www.biotechcorp.com.my Tham, L.H. and Yahya, I. (2008) Malaysian Pharmaceutical Industry Outlook 2008. Frost & Sullivan. www.malaysiamission.com

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cine and on the production of vaccines. In addition, a Bioproducts Validation Centre will also be established in Johor to validate herbal, nutraceutical, and phytopharmaceutical product claims for Commitment to Biotechnology the purposes of regulatory registration and quality Biotechnology has been identified as a new source assurance. (Ninth Malaysia Plan) of economic growth for Malaysia. To drive the development of this industry a new biotech policy Thrust 3: Industrial Biotechnology Developwas created, focusing on key concepts and meas- ment ures offered by the government of Malaysia. The This thrust will ensure growth in the application new policy was unveiled by the Prime Minister at of advanced bio-processing and biothe opening ceremony of the BioMalaysia 2005 manufacturing technologies. The identified areas conference at the Putrajaya International Conven- of growth include the development of biocatalysts tion Center. The Prime Minister outlined nine ma- such as enzymes for food and feed preparations, jor initiatives to realize the country’s potential in cleaning products, textile processing, and other this sector. (www.ita.doc.gov) industrial processes. Bioprocessing is another growth area which can be applied in the producSpeaking at the opening, the Prime Minister also tion of biomaterials such as bioplastics, biofuel, announced the newly created Malaysian Biotech specialty chemicals such as cosmetics ingredients, Corporation (MBC) to oversee the implementaand electronic chemicals. The third growth area tion of the new policy and initiatives. MBC is a under this thrust is contract biomanufacturing. dedicated and professional one-stop agency with (Ninth Malaysia Plan) the main objective of developing the country’s biotech industry. It is overseen by an Implementa- The Prime Minister explained in his speech that tion Council and advised by an International Advi- the above three thrusts will leverage the country’s sory Panel, both under the leadership of the Prime existing capabilities and to move them up the Minister of Malaysia. MBC coordinates biotech value chain. (Badawi, 2005) initiatives from all relevant government ministries—all under the purview of the Ministry of Thrust 4: R&D and Technology Acquisition Science, Technology and Innovation. MBC aims As part of this thrust Centres of Excellence will be to not only enhance biotech R&D, but also imestablished, in existing or new institutions, to prove the regulatory environment. bring together multidisciplinary research teams in (www.ita.doc.gov) coordinated research and commercialization initiatives. To further boost research productivity and shorten the time required to bring products to Biotechnology has been market, the acquisition of platform technologies identified as a new will be a key initiative under this thrust. For this purpose, a special RM100 million fund for biosource of economic technology acquisition has been established. It is growth for Malaysia. anticipated that international collaborations will be encouraged to facilitate both knowledge and technology transfer. (Ninth Malaysia Plan)

Crafting a National Biotechnology Policy

MESDAQ, will take into consideration the special characteristics of biotech companies with its long gestation periods and higher risk profiles. (Badawi, 2005) Thrust 7: Legislative and Regulatory Framework Development Under this thrust, the country’s regulatory framework and processes will be brought in line with global standards and best practices. As well, the country will further move to develop a strong intellectual property protection regime. Recognizing the necessity of a strong regulatory framework for the development of biotechnology, the Government is in the process of formulating and enacting a number of legislations. These include the Biosafety Bill and the Access and Benefit Sharing (ABS) Bill. The ABS Bill seeks to ensure fair and equitable sharing of benefits from the use of Malaysia’s biological resources and to protect against biopiracy. To foster innovation and safeguard investments in biotechnology, efforts will be strengthened to improve the intellectual property (IP) regime. Guidelines on IP sharing for researchers in public research institutions and in business collaborations as well as for local and foreign ventures will be developed. Related standards such as good laboratory practice (GLP) and good manufacturing practice (GMP) will be augmented to develop the contract research and contract manufacturing sectors. (Ninth Malaysia Plan) Trust 8: Strategic Positioning Under this thrust, global marketing strategy will be developed to build brand recognition for Malaysian biotechnology.

Trust 9: Government Commitment Under this thrust the Malaysian Biotechnology Corporation was established. The Malaysian Biotechnology Corporation works closely with all relevant agencies and ministries, such as the Ministry of Health, the Ministry of Agriculture & AgroThrusts of the Policy Trust 5: Human Capital Development Based Industries and the Ministry of Commodities Under this thrust, biotech human resources will be & Plantation Industries. Malaysian Biotechnology The National Biotechnology Policy comprises of developed through special schemes, programmes, Corporation works under the purview of the Minnine thrusts: (www.binasia.net) and training. Institutions of higher education will istry of Science, Technology and Innovation to augment their undergraduate and post-graduate enhance biotech R&D and to help improve the Thrust 1: Agriculture Biotechnology Develop- courses in order to expand scientific and special- regulatory environment. ment ized skills, especially in the fields of genomics, miThis thrust includes enhancing value creation of crobiology, bioprocessing as well as in related en- The Government also developed a network or the agricultural sector through biotechnology. The gineering and business fields. Colleges and skills nexus of centres of excellence from existing instiknowledge and expertise of institutions such as development training centres will be charged with tutions around the country—known as BioNexus MARDI, Malaysian Palm Oil Board, and the the responsibility of meeting demands for techni- Malaysia. (Badawi, 2005) Malaysian Rubber Board will be used to develop cal human resources such as biotechnology reniche areas. New technologies, spearheaded by search assistants, GMP personnel, and technicians The Government these institutions as well as the newly designated in biomanufacturing, metrology, and quality conMalaysian Genome Institute, will include bioinfor- trol. (Ninth Malaysia Plan) anticipates that these nine matics, genetic engineering, functional genomics thrusts and supporting and proteomics to discover new applications not Trust 6: Financial Infrastructure Development initiatives will steer the only in agriculture biotechnology, but also those in Prime Minister Badawi explained that as an initial healthcare and industrial biotechnologies. (Ninth step, the Government would be structuring dedigrowth of a competitive Malaysia Plan) cated matching grants for biotech R&D and combiotechnology industry. mercialization, including financial support for patThrust 2: Healthcare Biotechnology Develop- ent applications. To assist R&D ventures even furment ther, a fund would be established to assist in the The Government anticipates that these nine This thrust involves capitalizing on the strengths training of skilled workers and the hiring of rethrusts and supporting initiatives will steer the of biodiversity to commercialize discoveries in searchers in key areas. (Badawi, 2005) growth of a competitive biotechnology industry natural products as well as position Malaysia in the that not only leverages existing strengths but debio-generics market. The National Institute of Biotech businesses can also benefit from prepack- velops new ones in Malaysia. Pharmaceuticals and Nutraceuticals (NIPN) and aged tax incentives currently provided by the Govthe National Institute of Natural Products, Vacernment, including 10 year tax exempt pioneer References: cines and Biologicals (NINPVB) will be set up as status, exemption of import duties on approved 1) www.ita.doc.gov centres of R&D excellence in the field of health- equipment and materials, and double tax deduc2) www.binasia.net care-related biotechnology. The NIPN will focus tions on qualifying expenses and R&D invest3) Biotechnology for Wealth Creation. Ninth on the utilization of natural bio-resources from ments. To increase access to funds for biotech Malaysia Plan 2006-2010. plant, marine, and microbial origins for use in companies, venture capital participation will be 4) Speech by Yab Dato’ Seri Abdullah Bin Haji nutraceuticals, cosmeceuticals, and phytopharma- strengthened and entry to capital markets will be Ahmad Badawi Prime Minister of Malaysia, ceuticals. The NINPVB will focus on herbal medi- further enabled. For example, entry criteria into BioMalaysia 2005.
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The BioNexus Network
Objective

A company that invests in its subsidiary, which is a BioNexus status company, is granted a tax deduction equivalent to the amount of investment made in that subsidiary provided that the investing company owns at least 70% of that subsidiary.

The Government developed a network or nexus of centres of excellence A BioNexus company is given concessionary tax rate of 20% on infrom existing institutions around the country known as BioNexus Malaysia.  come from qualifying activities for 10 years upon the expiry of the tax exResources were initially dedicated to the development of three Centres of emption period. Excellence. The Centre of Excellence for Agricultural Biotechnology is focused around MARDI and Universiti Putra Malaysia. The Centre of Excel A company or an individual investing in a BioNexus company is given lence for Genomics and Molecular Biology is focused in Universiti a tax deduction equivalent to total investment made in seed capital and Kebangsaan Malaysia. The Centre of Excellence for Pharmaceuticals and early stage financing. Nutraceuticals is anticipated to be built in the original BioValley site in Dengkil. These Centres of Excellence will be used to attract other institu A BioNexus company undertaking a merger and acquisition with a tions and companies in related areas of expertise. Furthermore, it is anticibiotechnology company is given exemption of stamp duty and real proppated that these Centres of Excellence will connect with other BioNexus erty gains tax within a period of 5 years until 31 December 2011. centres in the country as part of a network of collaboration and information exchange. (Badawi, 2005)  Buildings used solely for the purpose of biotechnology research activities are given an Industrial Building Allowance over a period of 10 years. BioNexus Status Companies (www.biotechcorp.com.my) Another major component of BioNexus is to confer special status to selected domestic and foreign companies that are then eligible for financial BioNexus Companies support, tax incentives, and access to equipment and facilities. BioNexus status is essential to accessing major government funding and eventual listBioNexus companies include those from the agricultural biotechnology, diing on MESDAQ. (Yuan, 2007) Approximately 100 companies are in the agnostics, genomics, drug discovery and development, medical product depipeline to obtain the BioNexus status, which will make them eligible for velopment, animal health, and research services arenas. (See Page 15) privileges contained in the BioNexus Bill of Guarantees according to chief executive officer Datuk Iskandar Mizal Mahmood. (www. biomalaysia.com.my) Key incentives available for qualified biotechnology companies with BioNexus status include several tax incentives. These fiscal incentives are further strengthened by a set of privileges granted under a Malaysian Government Bill of Guarantees. (biomalaysia.com.my; www.bionetasiapacific.com)

Approximately 100 companies are in the pipeline to obtain the BioNexus status.

Fiscal incentives are further strengthened by a set of privileges granted under a Malaysian government Bill of Guarantees.

Agricultural Biotechnology includes: Plant genomics, fertilizer & soil enhancer, plant propagation via tissue culture, animal breeding and reproduction technology, nutraceuticals, and orchid tissue culturing. Industrial Biotechnology includes: Bioremediation, enzymes/catalysts, biodiesel production, microbes technologies, and biocatalysts. References:

Specifically the BioNexus’ Bills of Guarantees (BOG) allows:
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1) Speech by Yab Dato’ Seri Abdullah Bin Haji Ahmad Badawi Prime Minister of Malaysia, BioMalaysia 2005. 2) Yuan, R. (2007) Malaysian Gov't Fosters Biotech Growth. Genetic Freedom of ownership; Engineering and Biotechnology News, Vol. 27(15). Freedom to source funds globally; 3) www.biomalaysia.com.my Freedom to bring in knowledge workers; 4) www.bionetasiapacific.com Eligibility for competitive incentives and other assistance; 5) www.biotechcorp.com.my Eligibility to receive assistance for international accreditations and standards; Strong intellectual property (IP) regime; Access to a supportive information network linking research centres of excellence; Access to shared laboratories and other related facilities; Access to BiotechCorp as the one-stop agency.

For Information on Investment Opportunities:

BioNexus status companies may apply for the following tax incentives from the Malaysian Government:

100% income tax exemption for 10 years commencing from the first year the company derives profit OR Investment Tax Allowance of 100% on the qualifying capital expenditure incurred within a period of 5 years. Tax exemption on dividends distributed by a BioNexus company. Exemption of import duty and sales tax on raw materials/components and machinery/equipment. Double deduction on expenditure incurred for R&D. Double deduction on expenditure incurred for the promotion of exports.

Malaysian Biotechnology Corporation Sdn. Bhd. Level 23, Menara Naluri 161 Jalan Ampang 50450 Kuala Lumpur Tel : (603) 2116 5588 Fax : (603) 2116 5577 E-mail : info@biotechcorp.com.my

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BIONEXUS COMPANY
All Cosmos Industries Sdn Bhd ar-Raudhah Bio Tech Farm Sdn Bhd Asia Pacific Special Nutrients Sdn Bhd Asiatic Centre for Genome Technology Sdn Bhd Asma Agro Malaysia Sdn Bhd Aurigene Discovery Technologies (M) Sdn Bhd Autoimmune Sdn Bhd Bio Molecular Industries Sdn Bhd Biotech Alliance International Sdn Bhd Biotec International Asia Sdn Bhd BioFact Life Sdn Bhd Bio-Fertilizers Sdn Bhd BioSmart Sdn Bhd Biovic Sdn Bhd Borneo Plant Technology Sdn Bhd CellSafe International Sdn Bhd Chakra Biotech Sdn Bhd DNA Laboratories Sdn Bhd First Base Laboratory Sdn Bhd GENERTI Biosystems Sdn Bhd Genetic Improvement and Farm Technologies Granulab Sdn Bhd Healol Melaka Biotech Sdn Bhd Holista Biotech Sdn Bhd Hopematic Sdn Bhd Inno Biologics Sdn Bhd Inno Intergrasi Sdn Bhd InQpharm Asia Sdn Bhd IPT Kosmo BioTechnology Sdn Bhd KL Biotech Manufacturing Sdn Bhd Malaysian Agri Hi-Tech Sdn Bhd Malaysian Bio-Diagnostics Research Sdn Bhd Malaysian Genomics Resources Centre Nimura Genetic Solutions Sdn Bhd Nova Laboratories Sdn Bhd Olipro Biotechnology Sdn Bhd Orchid Life Sdn Bhd Power Biotechnologies Sdn Bhd Profound Vaccine Sdn Bhd Renogenic Sdn Bhd StemLife Berhad Stevian Biotechnology Corporation Sdn Bhd Stempeutics Research Malaysia Sdn Bhd Success Nexus Sdn Bhd Sunzen LifeSciences Sdn Bhd TSH Biotech Sdn Bhd Vivantis Technologies Sdn Bhd

FOCUS
Agricultural Biotechnology Agricultural Biotechnology Diagnostics Genomics Genomics Drug Discovery Drug Discovery Drug Development Industrial Biotechnology Industrial Biotechnology Drug Development Agricultural Biotechnology Industrial Biotechnology Medical Product Development Drug Development Biotechnology Drug Discovery Diagnostics Contract Research Diagnostics Agricultural Biotechnology Medical Product Development Drug Development Health Services Drug Development Research Services Agricultural Biotechnology Drug Discovery/Development Industrial Biotechnology Drug Development Agricultural Biotechnology Diagnostics Genomics/Contract Research Contract Research Drug Development (Animal Health) Diagnostics Agricultural Biotechnology Agricultural Biotechnology Animal Health/Vaccines Biotechnology Research Services Agricultural Biotechnology Medical Product Development Industrial Biotechnology Drug Development (Animal Health) Agricultural Biotechnology Research Services
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A Malaysian Entrepreneur Development Framework
The Malaysian Biotechnology Corporation (BiotechCorp), the lead agency to develop the biotechnology industry in Malaysia, is stepping up efforts to ensure that human capital development is ready to meet the requirements of the next phase in the Malaysian biotechnology industry. (www.biomalaysia.com.my) ―In fact, the growth and success of the biotechnology sector in the commercialization phase— hinges on our success in expanding the capability and competency of our people in biotechnology. Thus, we have a very ambitious target of expanding the pool of knowledge workers in biotechnology from 40,000 in 2011 to 80,000 by 2015‖, said Datuk Iskandar Mizal Mahmood, the Chief Executive Officer of BiotechCorp. (www.biomalaysia.com.my) BiotechCorp has developed the Biotechnology Entrepreneur Development Framework. The Biotechnology Entrepreneur Development Framework provides a comprehensive approach to developing new entrepreneurs, facilitating the creation of new biotechnology start-ups/business ventures, and transforming ideas/business concepts into those ready for commercialization. A series of programmes have been developed to enable entrepreneurs along the various stages of development. These programmes cover entrepreneur development workshops, entrepreneur development conferences, and mentoring programmes. (www.biomalaysia.com.my) The Biotechnology Entrepreneurship Special Training (BeST) Programme BeST is a six-month intensive and structured retooling programme for biotechnology/life-sciences graduates wishing to enter the biotechnology industry and other industries in general. BeST combines classroom-based instruction, with laboratory work and an industry internship. The programme is aimed at equipping graduates with essential skills and knowledge for entry-level positions within biotechnology companies or biotechnology-related companies. (www.biotechcorp.com.my) California Institute for Quantitative Biomedical Research (qb3) BiotechCorp has also established a five-year partnership with the California Institute for Quantitative Biomedical Research (qb3) to collaborate in the areas of research, human capital, and bio-entrepreneurship development. The partnership enables collaborations on research projects and classroom training to equip Malaysian scientists with the latest multi-disciplinary and biotechnology entrepreneurship skills. All the students in this program attend QB3 with the anticipation of forming networks with each other as well as with QB3 scientists. After the formal training, all the students return as staff to the new National Institute for Pharmaceuticals and Nutraceuticals. It is hoped that the trainees should be able to transfer the entrepreneurial skills they have acquired back to Malaysia. (qb3.org/malaysia.htm) Mentor in Residence Programme The Mentor-In-Residence Programme is a part of the Mentoring Programme. Under the Mentor-In-Residence Programme, BiotechCorp intends to engage the services of experienced CEOs/industry leaders from around the world to serve as mentors. These mentors are envisioned to bring a wealth of industry expertise and experience that will be shared with companies/individuals participating in the mentoring programme.

PROGRAMME The Biotechnology Entrepreneurship Special Training (BeST) Programme California Institute for Quantitative Biomedical Research (qb3) Mentor in Residence Programme

COMPONENTS Six-month intensive and structured retooling programme for biotechnology/life-sciences graduates. Research, human capital, and bioentrepreneurship development.

Connection with international mentors. BioNexus Partner Programme Network creation with Malaysian universities, research institutes, government linked companies, technology parks, and incubators. BioNexus Partner Programme (BNP) The BioNexus Partner Programme will leverage on existing facilities, infrastructure, and capabilities within Malaysian universities, research institutes, government linked companies, technology parks, and incubators. As of November 2008, the Forest Research Institute Malaysia (FRIM) and seven local public universities signed an agreement under the BioNexus Partners (BNP) programme to strengthen their research and development (R&D) capacity. (FRIM, 2008) BNP partners include: The International Islamic University Malaysia, Universiti Teknologi Mara, Universiti Malaya, Universiti Malaysia Terengganu, Universiti Putra Malaysia, Universiti Sains Malaysia, Universiti Teknologi Malaysia, and Forest Research Institute Malaysia. (Yunus, 2009) References: 1) 2) 3) 4) www.biomalaysia.com.my www.biotechcorp.com.my qb3.org/malaysia.htm Yunus, K. BioNexus firms can capitalise on woes. Business Times, January 24 2009.

“..we have a very ambitious target of expanding the pool of knowledge workers in biotechnology from 40,000 in 2011 to 80,000 by 2015.”

For Information on Investment Opportunities:
Chemical & Life Sciences Industries Division Malaysian Industrial Development Authority Block 4, Plaza Sentral, Jalan Stesen Sentral 5, Kuala Lumpur Sentral, 50470 Kuala Lumpur, Malaysia Tel : (603) 2267 3633 Fax : (603) 2273 4192 Website : www.mida.gov.my E-mail : lifesc@mida.gov.my

“In fact, the growth and success of the biotechnology sector in the commercialization phase— hinges on our success in expanding the capability and competency of our people in biotechnology. ..”

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Safety Reporting Dr. Izabela Slowik
PharmaVigilance Consulting Group, Warsaw

& Dr. Anjali Shukla

Accure Labs Pvt. Ltd., India How well-prepared are we to monitor, report, document, and evaluate adverse drug reactions / events (ADRs/AEs) arising from clinical trials as well as from the marketed new medicinal products? Monitoring and reporting adverse events from clinical trials may be relatively a simpler process, considering the given settings and environment that are ensured by GCP. But the same cannot be assumed for marketed drug products. First of all, we have to admit that it is essential to report ADRs. Several questions arise in context with safety reporting requirements. These are: 1. What to report? 2. Why to report? 3. When to report? 4. How to report?

conducted during the pre-authorization phase were limited to the special group of patients, in terms of age, gender, and ethnicity. There were also a small numbers of subjects enrolled to the clinical trials. Restricted conditions were used in the protocols regarding co-medication, duration of exposure (relatively to short), and lack of follow up.

Situations where less frequent submission of PSURs may be appropriate include: Products authorized through line-extensions to existing medicinal products. Newly authorized generic medicinal products.

What to Report Periodic Safety Update Reports (PSURs) for marketed products form the mainstay of traditional, post marketing surveillance activities throughout the pharmaceutical world. US FDA’s MedWatch forms & MHRA’s Yellow Cards have almost become synonymous with spontaneous reporting. While the US FDA recommends voluntary spontaneous reporting of all serious suspected ADRs through Form 3500A for health care professionals, it makes such reporting mandatory for the Marketing Authorization Holders (MAHs) and draws very stern timelines and reporting obligations. All other ADRs/AEs, which are not reported to regulators, in an expedited manner are included in periodic clinical trial reports (in case of premarketed development phase) and in PSURs for marketed products. A PSUR is intended to provide an update of the worldwide safety experience of a medicinal product to Competent Authorities (CA) at defined points post-authorization. At these times, MAHs are expected to provide concise summary information together with a critical evaluation of the riskbenefit (R/B) balance of the product in the light of new or changing information. This evaluation should determine whether further investigations need to be carried out and whether changes should be made to the marketing authorization and product information. Why to Report At the time of authorization, the safety profile of the product is not complete. Clinical trials

Situations where more frequent submission of PSUR is intended to provide an update of the PSURs may be required include: worldwide safety experience of a medicinal product to Competent Authorities at defined time Variations introducing new indications, dosage points during the post-authorization phase. PSUR forms, and routes of administration. for marketed medicines is a stand-alone document. It is completed according to the ICH tem- An API which is a different salt/ester or derivaplate. Data from the MAH observations as well as tive (with the same therapeutic moiety). results from the clinical trials and published in the literature are all presented. This enables for the The presence of an inactive substance without an evaluation of all available worldwide safety data of established safety profile. marketed drugs. A Risk Management Plan (RMP) in place for a When to Report corresponding originator product requiring specific monitoring of a safety concern. Once a medicinal product is authorized in the European Union (EU), even if it is not marketed, the MAH is required to submit PSURs at 6- European PSUR Work Sharing Project monthly intervals. When launch dates are planned, this information should be reflected in the forth- Companies have proposed dates for substances for which they considered their product to be the coming PSUR. originator, and this was used as a basis for compilPSURs should be submitted at the following times ing a list of EU HBD and DLPs for active substances. This list has now been adopted by all nafrom the time of authorization, for all medicinal tional agencies and is published on the HMA webproducts unless the marketing authorization site. makes different provisions:  Immediately upon request.  At least 6 monthly after authorization and un- Under the scheme all products involving the same API will have the same EU HBD and DLP and til placement on the market. therefore the same PSUR submission cycle. This  At least 6 monthly for the first two years after will allow sharing of the PSUR assessment work being placed on the market. load across the EU. Each API will be allocated a P  Annually for the subsequent two years. -RMS (Reference Member State for the PSUR)  Thereafter at three-yearly intervals. who will take the lead in the assessment. For muThe first PSUR should have a data lock point tually authorized licenses the P-RMS and RMS (DLP) within 6 months after granting of the mar- may not be the same EU member state. There is keting authorization. European agreement that the PSUR cycle for generic products may move directly to the threeFor nationally authorized products, including yearly cycle in line with the brand leader rather those authorized through mutual recognition or than start with six-monthly PSURs, unless potendecentralized procedures, initiatives have been tial safety issues that may require monitoring are taken by the National Competent Authority identified in the Safety Assessment included (NCA) to synchronize PSUR submission schedwithin the registration dossier. ules for products containing the same Active Pharmaceutical Ingredient (API). For many APIs, The request to amend the PSUR cycle should be harmonized ―virtual‖ birth dates, known as EU included in the registration dossier and supported Harmonized Birth Dates (EU HBDs) and related in the Safety Assessment. This will be agreed as harmonized DLPs for the following PSURs have part of the marketing authorization approval. If a been agreed upon by the relevant MAHs for origi- request to amend the PSUR cycle is not received nator products and NCAs. These harmonized then the PSUR cycle will default back to 6 birth dates and related data lock points are pubmonthly reports for two years, annually for two lished by the Heads of Medicines Agencies years, and then every three years thereafter. (HMA). MAHs for generic products are encouraged to use the same PSUR submission schedules The focal point of the PSUR should be the presas those agreed for originator products. entation, analysis, and evaluation of new or changing safety data received during the period covered Medicinal products, which are also authorized out- by the PSUR. So the following things should be side EU, will have an International Birth Date adequately addressed in the PSUR: (IBD). In order to harmonize PSUR submissions internationally, the MAH may use the IBD to de- 1. Analysis of adverse reaction reports. termine the dates of the DLPs for the PSUR sub- 2. An overview of cumulative data. mission schedule, provided that the first DLP falls 3. Safety data from studies. within the 6 months following the EBD (EU Birth 4. Other relevant safety information. Date). 5. Follow-up of any Risk Management. 6. Reports of lack of efficacy, specifically for meThe periodicity of PSUR submission may be dicinal products used in the treatment of lifeamended, as required by the CA or proposed by threatening conditions and for certain other methe MAH. This may result in more or less frequent dicinal products (contraceptives and vaccines). submission of PSURs. However, submission of PSURs at a lower frequency than once every 3 (Continued on Page 22) years is not possible.
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(Continued from Page 21) Information on all indications, dosage forms, routes of administration and dosages for a given API for medicinal products authorized to one MAH should be included in a single PSUR, with a single DLP common for all aspects of product use to facilitate a consistent, broad-based examination of the safety information for the API in a single document. In exceptional cases, EMEA (European Medicines Agency), the CA or the MAH may consider it appropriate to have a separate PSUR. For example: Products authorized through line extensions to existing medicinal products (e.g. an API in two or more different formulations for systemic versus topical administration) with cross-reference between PSURs, if appropriate. Fixed combinations, where options include either a separate PSUR for the combination with cross-reference to the singlesubstance PSUR or inclusion of the fixed combination data within one of the single-substance PSURs.

Strengths
Aggregate data (to better identify new safety signals). Worldwide data (safety signal strengthened if seen in more than one country). Multiple sources of information (also strengthens the safety signal). Opportunity for re-assessment of safety profile. Assessment and rationale for updating Company Core Data Sheet / Company Core Safety Information [(CCDS/CCSI] (Driving updates of Package Inserts worldwide). Interim snapshot of safety reports.

Weaknesses
Does not explain all prior safety issues. Line-listings provide limited information for assessing a case. No set numerator or denominator to calculate incidences. Retrospective, potentially biased. Safety signal not verified.

Causality for events cannot be determined based on information in a PSUR (The pivotal problem for pharmacovigilance: What events are really due to use of the drug product?)

UPCOMING EVENTS
DIA’s 1st Workshop on Pre-market Evaluation of Quality and Bioavailability Hyderabad, India 05/02/2009 - 06/02/2009 This workshop will clarify the approval requirements for drugs developed in India for global markets. Clinical Research Outsourcing in Asia at Outsourcing Asia Summit 2009 Singapore 18/02/2009 - 20/02/2009 Share knowledge and practical experience of outsourcing business processes. Clinical Trials in Emerging Markets InterContinental Hotel, Vienna, Austria 24/02/2009 - 25/02/2009 Co-located with Clinical Trial Supply and Cold Chain Storage and Distribution. New Dates! Drug Discovery and Clinical Development in India Mumbai, India 25/02/2009 - 28/02/2009 Discuss solid scientific research in India pertaining to global development of drugs and biologics. BioMedical Asia 2009 Singapore 16/03/2009 - 19/03/2009 Explore partnership and investment opportunities and discuss best operational strategies and successful business models.
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The benefits of a particular medicine should exceed the risks by the greatest achievable margin for the individual patient and for the target population as a whole.

“Happy Reporting”
All said and done, there are both strengths and weaknesses of PSURs. The benefits of a particular medicine should exceed the risks by the greatest achievable margin for the individual patient and for the target population as a whole. When the new risk is identified and benefit is still positive the following actions can be proposed by MAH: 1. Supplementation of the Summary of Product Characteristic and Patient Information Leaflet. 2. Active surveillance under identified risks (non-interventional study, letter to the doctors requesting for additional reports, educational materials etc.). 3. Risk minimization plan preparation and risk minimization strategy development. 4. Risk communication.

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A Rising Star: Malaysia’s Pharmaceutical Industry According to Lin Hui Tham, consultant of Healthcare Asia Pacific at Frost & Sullivan, the boost in Malaysia’s pharmaceutical industry is being driven by the increasing numbers of pharmaceutical manufacturers that have sought to outsource to or in-license their operations from the country.

BioMalaysia

For example, pharmaceuticals firms are increasingly BioMalaysia is Malaysia’s premier and largest biotechnology outsourcing some of their clinical work to contract conference and exhibition. Held annually, this significant research organisations (CROs) within Malaysia. event attracts the best of Malaysian and global biotechnology participants. The Malaysian government has played a significant role in providing initiatives to the pharmaceutical BioMalaysia 2008 surpassed the success of BioMalaysia industry including the provision of grants and financ2007—with over 7,800 participants including 60 biotechnoling schemes to support R&D initiatives. The country ogy experts from 30 countries speaking at the conference, also recently established the Penang Science Park at 1,100 conference participants, 85 international and local exBukit Minyak. hibitors, and 6,555 trade visitors. Visit BioMalaysia to learn more about the 2009 conference to be held at the Kuala Lumpur Convention Centre from November 17th to November 19th 2009. www.biomalaysia.com.my Malaysian Healthcare Industry Set to Grow this Year The park’s first tenant is a preclinical CRO—the first of its kind in Malaysia—and is part-funded by a UK venture capital fund. Called Progenix, the CRO is offering toxicology services to the global biopharma market and houses a range of mammalian species for the purpose, from mice through to primates. According to the firm, it has a particular area of expertise in inhalation toxicology.

The Malaysia’s healthcare industry is expected to grow at a rate of 8% in 2009 and is being supported by a RM 13.7 bil- Source: Barnes, K. Outsourcing-Pharma.com, April 8 lion budget (RM 13 billion in 2008). This is an increase of 2008. 5.35% from previous year, which represents 2 percent of Penang Halal Park GDP. Both healthcare providers and pharmaceutical companies are expecting increases in their market shares in 2009. Healthcare companies see the global economy crisis as an opportunity in emerging markets. Companies are prepared to take bold steps with acquisitions or joint ventures with niche medical technology players in China and India. The pharmaceutical industry anticipates opportunities for investment by foreign companies in the form of clinical research outsourcing and clinical trials. Source: BioSpectrum, January 16 2009. Malaysia Pharmaceuticals Expand into China China has agreed to facilitate the easy entry of Malaysian medical and pharmaceutical products, according to Health Minister Datuk Liow Tiong Lai. Following a bilateral negotiation recently, Liow said, China had agreed to give a greenlight to Malaysian products already approved by the ministry without too much bureaucracy and second testing. Source: The Star Online, January 27 2009.
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Two local halal firms with investments totalling over RM200 million will be the tenants at Penang’s Halal Industrial Park next year. Penang Chief Minister Lim Guan Eng said the country’s sole halal gelatine maker for pharmacies, Halagel (M) Sdn Bhd, will invest RM130 million and create 200 new jobs, while Granulab (M) Sdn Bhd, a member of Johor Corp, will invest between RM50 million and RM100 million for its synthetic bone graft material operations. Lim also said for the first phase in developing the Penang Halal Industrial Park, a 52.4ha plot which is adjacent to the Penang Science Park has been identified by the state government. The Penang Science Park at Bukit Minyak has attracted investments of over RM100 million to manufacture biotechnologyrelated products and medical devices. Sources: Emmanuel, M. Business Times, February 5th 2009; investPenang, July 4th 2008.

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