13. Ireland Irish Medicines Board
14. Italy Italian Pharmaceutical Agency
15. Malaysia National Pharmaceutical Control Bureau, Ministry of Health
16. Netherlands Medicines Evaluation Board
17. New Zealand Medsafe: Medicines and Medical Devices Safety Authority
18. Nigeria National Agency for Food and Drug Administration and Control
19. Pakistan Drugs Control Organization, Ministry of Health
20. Paraguay Ministry of Health
21. Singapore Centre for Pharmaceutical Administration Health Sciences Authority
22. South Africa Medicines Control Council
23. Sri Lanka SPC, Ministry of Health
24. Sweden Medical Products Agency (MPA)
25. Switzerland Swissmedic, Swiss Agency for Therapeutic Products
26. Thailand Ministry of Public Health
27. Uganda Uganda National Council for Science and Technology (UNCST)
28. Ukraine Ministry of Health
29. USA Food and Drug Administration (FDA)
Regulatory authorities ensure the safety, efficacy and quality of drugs which are
available to the public. These authorities also identify the strengths as well as
weaknesses of drug regulation and remedies to improve drug regulation. They also
play an important role to ensure and strengthen regulatory implementation in the
non-regulated world. The international regulatory organizations like WHO, ICH play
an essential role in manufacturing, approval, distribution, price control, research and
development, marketing and intellectual property rights protection.
7.4 ROLE OF REGULATORY AFFAIRS DEPARTMENT
Drug regulatory affairs is a dynamic and challenging field in the pharmaceutical
industry. It has to deal with government authority on one hand and applicant/company
on the other hand. Because of the crucial nature of the job, the regulatory affairs
professionals should be experts in managing the product life cycle. They should have
the capability to solve technical as well as administrative problems within the limits of
laws and regulations. Regulatory affairs department is a bridge between government
regulatory authority and pharmaceutical company. It also has a connection with all
the departments of the company internally (Fig. 7.3).
Regulatory affairs department plays many important roles. These are as follows:
Role in drug development: It is the regulatory affairs department that guides the
other professionals involved in product development regarding guidelines and norms
to be followed. Any change in the guidelines is monitored by regulatory affairs
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