REGULATORY AFFAIRS
Background
Regulations are complex systems of interrelated rules
that govern a broad range of activities, and these set of
rules are continuously undergoing review, amendment,
and supplementation. The primary objectives for
Regulations are to assure that these products are.
a. Effective – Ability of the medical product to act or exert
an effect as intended.
b. Safety – Ability of a medical product to exert its effects
whilst causing little to no harm, it can also refer to a state
where a medicinal product is free from any
contamination.
c. Quality – It Is the capacity of the medical product to
meet prespecified quality attributes or regulatory
specifications or can also be defined as a product
manufactured in compliance with Current Good
Manufacturing Practices.
Botswana Medicine Regulatory Authority was
established through Medicines and Related Substances
Act, 2013, to safeguard the Quality, Safety and Efficacy of
Medicinal products, Pharmaceuticals, Medical devices,
Veterinary medicines, and Food supplements.
As defined by TOPRA; Regulatory affairs is a profession
developed from the desire of governments to protect
public health by controlling the quality, safety, and
efficacy of products in areas including:
❖ Pharmaceuticals,
❖ Veterinary medicines,
❖ Medical devices,
❖ Pesticides,
❖ Agrochemicals,
❖ Cosmetics and complementary medicines,
and by licensing the companies responsible for the
discovery, testing, manufacture, and marketing of these
products, to ensure that they supply products that are
safe and make a worthwhile contribution to public health
and welfare.
A new class of professionals emerged to handle these
regulatory matters for companies. The regulatory affairs
department is a crucial part of the structure of
pharmaceutical companies. Regulatory affairs officers
act as a link between companies and regulatory
authorities, ensuring that products are manufactured and
distributed in compliance with appropriate legislation and
Regulations.
Presented by: Maikaego Nelson Moreri
Dossier Assessment Specialist
❖ Gathering, evaluating, organising, managing and
collating information in a variety of formats.
❖ Keeping track of the ever-changing legislation in
all the regions in which an organisation wishes to
distribute its products.
❖ Advising on legal and scientific restraints and
requirements.
❖ Gathering, Collating, and evaluating available
scientific data to respond to regulatory questions.
Regulatory Affairs oversees company compliance with
regulations and laws regarding the manufacture,
marketing and development of regulated products, this is
achieved through interactions between Regulatory Affairs
with worldwide, and local regulatory agencies to assure;
❖ Licencing,
❖ Registration,
❖ Development,
❖ Manufacturing,
❖ Marketing and Labelling
of pharmaceutical and medical products which are
carried out in compliance with applicable guidelines or
regulations.
The role of regulatory affairs is to develop and execute a
regulatory approach to ensure that the collective efforts
of the drug development team results in a product that is
approvable with the aid of international regulators
however is also differentiated from the competition in
some manner and also is to ensure that the company’s
activities, from non-clinical research through to
advertising and marketing and promotion, are conducted
in accordance with the rules and recommendations
established through regulatory authorities.
ARTICLE No.
Aston University
Master of Pharmacy
Role of the Regulatory
Professional
❖ Presenting registration documents to regulatory
agencies and carrying out any subsequent
negotiations necessary to obtain or maintain
marketing authorisation for the products
concerned.
❖ Giving strategic and technical advice at the
highest level in their companies, making
contribution both commercially and scientifically
to the success of a development programme and
the company as a whole.
Typical Employers of regulatory
affairs Officers
❖ Chemicals manufacturers/Distributors
❖ Pharmaceuticals manufacturers/Distributors
❖ Herbal treatments manufacturers/Distributors
❖ Medical devices manufacturers/Distributors
❖ Veterinary medicinal products
manufacturers/Distributors
❖ Homeopathic medicine
manufacturers/Distributors
❖ Research organisations/Distributors
❖ Botswana Medicines Regulatory Authority
Helping the organisation avoid problems caused by
poorly kept records, inappropriate scientific
thinking, or bad presentation of data.
❖ Moreover, the regulatory affairs department will
often take part in the development of product
marketing concepts and is ordinarily required to
approve packaging and advertising before it is
used commercially.
The Need of Regulatory Affairs in
the Botswana Pharmacy
curriculum
❖ Botswana has a developing pharmaceutical
sector, as the industry grows there is an increasing
need of regulatory affairs professionals to cater for
the current needs of industries for the local and
eventually the global population.
❖ There is a growing need to incorporate the most up
to date requirements of pharmaceutical industries
in the standard curriculum of Pharmacy Education,
where the students ought to be well versed in
Botswana Laws, Regulations, Guidelines and
guidance by Botswana Medicines Regulatory
Authority, this knowledge and understanding will
prepare students with the latest developments to
serve the industries.
Qualification and Trainings Required
❖ Choosing an undergraduate major towards a path
in regulatory affairs requires some thought as to the
specific sector in which one would like to work in.
❖ An individual planning to work as a regulatory
affairs specialist within the pharmaceutical
industry, for example, would be most competitive
with a Bachelor of Science in pharmacy,
pharmacology, pharmaceutical technology,
chemistry, or biochemistry.
❖ However, professionals with foundational skills in
biology, engineering, clinical sciences,
management, and writing are also highly sought-
after candidates for this diverse field.
Why Regulatory Affairs is important
❖ The Medicines and Related Substances
Regulations, 2019, which were Published on 27
December 2018, designed by the Government of
Botswana to protect public health.
❖ The regulatory affairs department ensures that
their organisations comply with all the regulations
and laws concerning their business.
❖ Proper conduct of regulatory affairs activities is
of considerable economic importance for any
company as the competitiveness of today’s
environment requires reduction in time taken to
get for a product to reach market; for example, a
new drug may cost millions of Pulas or Euros to
develop and even a 6 months delay in bringing it
to the market, this will have serious
consequences resulting in huge financial
constraints, or even worse, failures to fully report
all the available data or the release of product
bearing incorrect labelling, may easily result in
the need for a product recall.
❖ In either case the company may lose millions of
units of sales, not to mention the resulting
reduction in confidence of the investors, health
professionals and patients.
Regulatory Affairs is an attractive career preference
for graduate students from a scientific background
who enjoy communication and teamwork,
comfortable with multi-tasking and are keen to
expand their knowledge in the Pharmaceutical
world. Furthermore, it is a rewarding, intellectually
stimulating and highly regarded profession within
the pharmaceutical industry.
Regulatory affairs give guidance into early
development of medicinal products as well as
successful execution of significant clinical studies.