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VOLUME 2, NUMBER 7 July 2007
Pacific Bridge Medical 7315 Wisconsin Avenue, Suite 609E Bethesda, MD 20814 Phone: (301) 469-3400 Fax: (301) 469-3409 Email: email@example.com
Copyright © 2007 Pacific Bridge Medical. All rights reserved. This content is protected by US and International copyright laws and may not be copied, reprinted, published, translated, resold, or otherwise distributed by any means without explicit permission. Disclaimer: the information contained in this report is the opinion of Pacific Bridge Medical, a subsidiary of Pacific Bridge, Inc. It is provided for general information purposes only, and does not constitute professional advice. We believe the contents to be true and accurate at the date of writing but can give no assurances or warranties regarding the accuracy, currency, or applicability of any of the contents in relation to specific situations and particular circumstances.
SFDA ISSUES GUIDELINES FOR BIOLOGICAL EVALUATION OF MEDICAL DEVICES To standardize the biological evaluation and review of medical devices, the State Food and Drug Administration (SFDA) issued the Guidelines for Biological Evaluation and Review of Medical Devices on June 15, 2007. The Guidelines aim to effectively implement GB/T 16886 standards (identical to ISO 10993) in China. These standards will be compulsory for registration of applicable devices. The Guidelines do not cover issues of microbiological contamination, sterilization, disinfection, or virus control of medical devices that use animal tissue. Evaluation on the biocompatibility of a medical device is needed prior to a clinical study. According to the Guidelines, initial biological safety evaluation of medical devices or materials should be performed in compliance with GB/T 16886 standards and according to the relevant flowchart. Evaluation should be conducted by testing institutions qualified to do biological tests and experiments. In addition, when conducting biological testing, external tests should be completed before any animal tests. Biological test reports need to be prepared in compliance with relevant GB/T 16886 reporting requirements and be submitted. The Guidelines require manufacturers to conduct re-evaluation of the biological safety of a medical device if the following changes occur: • • • • • Changes to raw materials or technical conditions Changes to formulation, production process, or primary packaging Changes to finished products during storage Other changes to product registration application Evidence for adverse reactions in humans
The Guidelines also give detailed requirements on the issuance and review of Medical Device Biological Evaluation Reports. The reports should include, but not be limited to, the following: • • • • • • Strategy and procedures for medical device biological evaluation Selection of raw materials for device Description of raw materials used, including qualitative analysis, quantitative analysis, and equality comparison of raw materials versus products on the market Rationale for any waiver of biological testing Summary of existing data and test results Other supporting data
According to the Guidelines, when manufacturers require biological evaluation as part of product registration, they can provide their own or third-party biological evaluation reports instead of undergoing testing during
the registration process. Foreign manufacturers will have to provide evidence that the tests they submit are conducted by GLP-certified biological testing laboratories in the country of origin. SFDA PROMULGATES NEW PROVISIONS FOR DRUG REGISTRATION On June 18, 2007, the SFDA passed the revised Provisions for Drug Registration. On July 10, 2007, SFDA Commissioner Shao Mingli promulgated the Provisions as SFDA Order No. 28. They will go into effect on October 1, 2007. The existing Provisions, which came into effect on May 1, 2005, strictly regulated drug application, appraisal, and approval. However, they contained lighter requirements for verification of primary submission materials, on-site production inspections, and audits on quality control. This lack of supervision made it easier for drugmakers to file fake materials. The low standards for drug approval also failed to promote the development of innovative drugs, instead seeing a dramatic increase in generics. These supervision and transparency problems were the key concerns prompting the SFDA to revise the previous Provisions. The revised Provisions are made up of 15 chapters and 177 articles, shorter than the previous version. Major modifications include: raising drug safety standards; improving drug registration process supervision by integrating administrative resources; and upgrading drug appraisal and approval standards to encourage innovation. The new policy requires more product checks and on-site manufacturing checks during the application process. The new Provisions give more responsibilities to provincial food and drug administrations in the supervision process, and aim to encourage innovation by speeding up the approval procedure for innovative drugs. Compared to the old Provisions, the new Provisions have streamlined the sections governing pre-clinical and clinical trials. Before, this topic was covered by several different regulations, making compliance confusing for drugmakers. The new Provisions introduce stiffer punishments for companies that cheat in applications for new drugs. Applicants who submit false drug information or samples for clinical test approval will not only be rejected, but their other applications will also be refused for 12 months afterwards. Companies who are found to have wrongfully gained clinical test approvals will have those permits revoked, be fined RMB 10,000 to 30,000 (about $1,300 to $4,000), and have subsequent applications refused for three years. Anyone using fake materials or samples to apply to manufacture or import drugs will receive similar punishments, with a five-year ban on applications in the case that previous approvals were gained by cheating.
MOH INCREASES CENTRALIZED PURCHASING OF MEDICAL DEVICES In order to intensify the administration and supervision of medical device procurement, standardize hospital purchasing practices, fight corruption, and improve the viability of costly purchases, the Ministry of Health (MOH) recently issued a Notice on the Strengthening of Tender Purchasing of Medical Devices. According to the Notice, purchasing of medical devices through tendering will be organized and run by the central, provincial, and district-level governments. However, the MOH intends provincial-level systems to be the dominant venue for tendering. The Notice requires public hospitals at the county level and above, as well as nonprofit medical institutions affiliated with state-owned enterprises, to participate in centralized purchasing programs. Medical devices specified in the Notice include large medical equipment and medical consumables. Devices classified as “Class A Large Equipment” by the Provisions on Administration of Allocation and Utilization of Large Medical Equipment, as issued in 2004, will need to obtain Equipment Allocation Permission to be purchased. The MOH will organize tendering for these devices. It will also organize tendering for some particularly high-value medical consumables that vary widely in price and are used in relatively small numbers, such as cardiac pacemakers. On the other hand, “Class B Large Equipment” under the above Provisions and other high-value medical consumables will be purchased through tender systems by the health departments of provinces, autonomous regions, or municipalities. Provincial health departments will also be able to organize tendering for other medical devices not mentioned in the Provisions. According to the Notice, open tendering should be the main type of purchasing used. However, for high-value medical consumables, methods like selective bidding and competitive negotiation can be used instead. The Notice also encourages provinces to extend the online systems currently used for provincial drug purchasing to also be used for medical devices. Local administrations are urged to conduct evaluations on medical device applicants, establish databases for suppliers and products, and better prereview the qualifications of suppliers and products to select products with mature technologies and wide-range applications. Local administrations are required to develop implementation plans following the directions of the Notice in a timely manner and intensify the tender purchasing of medical devices within their jurisdictions. They should submit reports to the MOH by the end of July 2007 describing their device purchasing over the past year and their plans for future implementation.
AQSIQ SETS NEW STANDARDS FOR MEDICAL DEVICE IMPORTERS To improve standards for imported medical devices and streamline their supervision, China’s General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) released the Provisions on the Management of Inspection and Supervision of Imported Medical Devices on May 30, 2007. These Provisions will be implemented starting December 1, 2007. The main effect of the Provisions is to divide medical device importers into categories based on facilities, personnel, and track record. They also mention that AQSIQ will establish an early warning mechanism for imported medical devices. Different categories of importers will be treated differently in inspections. The categories are Types 1, 2, and 3, where Type 1 is the most qualified and Type 3 is the least. The requirements for being awarded Type 1 or 2 status include the following: Type 1 5 years Type 2 3 years
A history of following relevant laws, regulations, and quality standards for… Quality management system… Number of qualified quality management personnel… No history of recalls, refunds, or other incidents due to quality for… Continuously engaged in importing medical devices for… Over the past 2 years, annually imported no less than…
Meets AQSIQ standards and has ISO 9000 certification 2 2 years
Meets AQSIQ standards 1 1 year
6 years 30 batches of medical devices
3 years 10 batches of medical devices
Other requirements for both Type 1 and 2 importers include archiving relevant regulations and standards, as well as demonstrating appropriate technical training and after-sale services. After-sale services can be contracted to a third party. Applications are voluntary, so the Provisions should not prevent any importers from operating just because they are not classified. However, an
importer which does not apply for classification will be automatically treated as Type 3. An importer’s type will directly affect how often its shipments receive on-site inspections as opposed to supervision inspections. According to the Regulations, the required percentages of on-site inspections out of the total, based on device risk classification and importer type, are as follows: Type 1 General-risk 10% Relatively high- 30% risk High-risk 50% Type 2 30% 50% 100% Type 3 50% 100% 100%
It is not clear whether the three classifications of device risk referred to here are identical to Classes I, II, and III as defined by the SFDA. The Provisions say that AQSIQ will issue a catalog of device risk classifications at least 60 days before implementation. SFDA INTENSIFIES ADR REPORTING AND MONITORING IN CHINA The SFDA recently held a National Adverse Drug Reaction (ADR) Directors’ Working Meeting in the city of Kunming, Yunnan province. Officials from the SFDA’s Department of Drug Safety and Inspection, the National Center for ADR Monitoring, and directors from the 33 provincial ADR monitoring centers attended the Congress. During the two-day meeting, the National Center for ADR Monitoring presented its annual work report. Seven provincial ADR monitoring centers, including the Beijing center, shared their experiences. The meeting was carried out to analyze the current situation, study existing problems and challenges, and to discuss future development focuses and strategies for reporting and monitoring adverse drug reactions in China. The SFDA officials at the meeting addressed the difference between technical monitoring and administrative supervision and discussed the relationships between provincial and national monitoring centers. After over seven years of development, the nationwide ADR reporting and monitoring system has become an important force in Chinese drug safety. It played a significant role in handling drug safety-related emergencies in 2006. SFDA statistics show that the national and provincial ADR monitoring centers received a total of 369,000 reports on adverse drug reactions in 2006 as well as 14 multi-injury adverse drug reactions. The MOH and SFDA jointly promulgated the Provisions for Adverse Drug Reaction Reporting and Monitoring in April 2004. The Provisions require all drug manufacturers, distributors, and medical institutions to file an “Adverse Drug Reaction Report” when any severe injury or death related to a marketed drug occurs. Events involving severe injuries should be reported to
provincial monitoring institutions within 15 working days, and events involving death should be copied to the National Center for ADR Monitoring as well. Investigations and reports will be made by the provincial or national centers and be sent to the SFDA or MOH. In the early 1990’s, China launched a pilot program for ADR monitoring in 14 medical institutions in Beijing and Shanghai. The interim Provision for Adverse Drug Reaction Monitoring in November 1999 began to develop a nationwide ADR reporting system. Besides the National Center for ADR Monitoring, a total of 33 provincial-level ADR monitoring centers have been established to date.
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