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Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, Biologics and functional foods).

Regulatory Affairs professionals usually have responsibility for the following general areas:

• Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
• Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business. i.e. working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).
• Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.

Healthcare RA

Origins

The healthcare industries were the first to be significantly regulated in the modern era. Much of this regulation has stemmed from avoiding the repetition of disasters, and has tended to be led by the USA due to size of the market and its technological lead:^[1]

• Diphtheria Epidemic led to 1902 Biologics Control Act
• Publication of The Jungle by Upton Sinclair led to 1906 Pure Food and Drugs Act
• Elixir of Sulfanilamide led to the 1938 Food Drug and Cosmetic Act
• Thalidomide led to the 1962 Kefauver-Harris Amendments
• Dalkon Shield led to the 1976 Medical Device Amendments
• Bjork-Shirley Heart Valves led to the 1990 Safe Medical Devices Act

In the USA, this regulation is largely written directly into law and codified in Title 21 of the Code of Federal Regulations ^[2]

Recent Developments

In the late 1980's the European Community (later the European Union) started to harmonize the regulation of healthcare products in the member states.^[3] The concept of regulating medicines was well established in most member countries along similar lines to the US of model, but many countries did not have any significant medical device regulation. Concurrently the EU had been developing the concept of [New Approach Directives] where only broad concepts were written into the law and the bulk of the technological detail delegated to compliance with recognized standards (which are more readily update-able). ^{[4] [5] [6]}

The Europeans took the radical approach of applying the New Approach Directive to Medical Devices and by doing so made the first significant conceptual advance in healthcare regulation for nearly 100 years.

The European Model for medical device has largely been adopted by the Global Harmonization Task Force as the internation template. ^[7]

Future Developments

Many in the Reglatory Affairs Profession believe the New Approach to regulation will eventually be adopted for all healthcare products as it represents the best model for delivering new healthcare advances to market in a reasonable time with acceptable safety. ^[8]

Regulatory Affairs Profession

The (Healthcare) Regulatory Affairs Profession is still an emergent profession but has two major interational professional membership societies:

• The Regulatory Affairs Professionals Society, RAPS, http://www.raps.org
• The Organisation for Professionals in Regulatory Affairs, TOPRA, http://www.topra.org

which offer education and training, professional development, competence certification and codes of ethics. ^{[9] [10]}

The regulatory professional typically has a background relevant to the business in which they work, i.e., science, medicine, or engineering.

References

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