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Regulatory Affairs


Regulatory Affairs interacts with worldwide, federal, state, and local regulatory agencies (e.g., FDA (US), TGA (Australia), MHRA (UK), MCC (South Africa), etc)


Regulatory Affairs - What is it?


Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements – all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs department ensures that their companies comply with all of the regulations and laws concerning their business.

The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical companies. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.


Regulatory Affairs Defined


Regulatory Affairs is a specialized profession within the pharmaceutical/biotechnology sector.
Regulatory Affairs oversees company compliance with regulations and laws pertaining to the manufacture, marketing and development of regulated products.
Regulatory Affairs acts as point of contact between the company, its products and regulatory authorities
Regulatory Affairs interacts with worldwide, federal, state, and local regulatory agencies (e.g., FDA (US), TGA (Australia), MHRA (UK), MCC (South Africa), etc) to assure…
licensing,
registration,
development,
manufacturing,
marketing and
labeling
…….of pharmaceutical and medical products are conducted in compliance with all applicable rules


Regulatory Framework


Development, approval for marketing, manufacturing, and ongoing compliance of pharmaceutical/biotech products is among the most regulated activities of any industry.
Regulations are complex systems of interrelated rules that govern a broad range of activities.
These rules are continuously undergoing amendment and supplementation.
Their main function is to assure that these products are safe (do no harm) and effective (do some good)

Why do we pay so much attention to regulation and process?


It takes 8 to 15 years to develop a new drug/biologic product. Costs up to $ 800 million.
Attention to early development, successfully execution of significant clinical studies helps to reduce number of development failures.
Regulatory affairs provides insight/guidance into this development through agency wisdom collected in guidance, previous experience, market precedence, etc.
Compliance with Regulator expectations therefore equates with development success. Patient Protection is of greatest importance.

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