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
A biologic is a medicinal product such as a vaccine, blood or blood component, allergenic, somatic cell, gene therapy, tissue, recombinant therapeutic protein, or living cells that are used as therapeutics to treat diseases...
and functional foods).
Regulatory affairs professionals (aka regulatory 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
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
or European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(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.
The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:
- medical devices
- in vitro diagnostics
- biologics and biotechnology
- nutritional products
- veterinary products
The regulatory professional's roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and postmarket surveillance
Postmarketing surveillance is the practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market and is an important part of the science of pharmacovigilance...
Regulatory professionals come from diverse backgrounds. Most regulatory professionals have earned a bachelor's degree, and more than half have an advanced degree, most often in a scientific or technical field. In addition, regulatory professionals usually have experience in other careers before transitioning into regulatory affairs.
Although there are some university degree and graduate certificate programs in regulatory affairs and related areas, experience is a key asset for regulatory professionals. Valuable skills include project management and organization, negotiation and communication, and the ability to learn from the experience of others, both inside and outside the organization.
Continuing education and professional development are critical to the regulatory professional. Regulatory professionals must keep up to date with regulatory policies and procedures for one or more countries, as well as maintain an understanding of the scientific and technical background of healthcare products.
For more information about the knowledge, skills and abilities of regulatory professionals, read the RAPS white paper, Regulatory Affairs Professional Development Framework: An Overview or see The Regulatory Career Advancement Guide.
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:
- 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 was introduced as a sedative drug in the late 1950s that was typically used to cure morning sickness. In 1961, it was withdrawn due to teratogenicity and neuropathy. There is now a growing clinical interest in thalidomide, and it is introduced as an immunomodulatory agent used...
led to the 1962 Kefauver-Harris Amendments
- Dalkon Shield
The Dalkon Shield was a contraceptive intrauterine device developed by the Dalkon Corporation and marketed by the A.H. Robins Company. The Dalkon Shield was found to cause severe injury to a disproportionately large percentage of its users, which eventually led to numerous lawsuits in which...
led to the 1976 Medical Device Amendments
- Bjork-Shiley 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
The Code of Federal Regulations is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the Federal Government of the United States.The CFR is published by the Office of the Federal Register, an agency...
in 1980 starting (later the European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
) started to harmonize the regulation of healthcare products in the member states. The concept of regulating medicines was well established in most member countries along similar lines to the US model, but many countries did not have any significant medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
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).
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
The Global Harmonization Task Force is “a voluntary group of representatives from national medical device regulatory authorities and the members of the medical device industry” whose goal is the standardization of medical device regulation across the world...
as the internation template.
Many in the Regulatory 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.
Regulatory Affairs departments are growing within the companies. Due to the changing resources necessary to fulfill the regulatory requirements some companies also choose to outsource or outtask regulatory affairs to external service providers.
Regulatory Affairs Profession
The (Healthcare) Regulatory Affairs Profession is still an emergent profession but has two major international 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.
In Canada, the major professional membership society is:
- The Canadian Association of Professional Regulatory Affairs, CAPRA, http://www.capra.ca
Groups related to regulatory affairs issues are active at many social networking websites like LinkedIn and Facebook. FarmavitaR, http://www.farmavitar.net/ ,is managing social networking website dedicated exclusively to regulatory affairs professionals.
The regulatory professional
A professional is a person who is paid to undertake a specialised set of tasks and to complete them for a fee. The traditional professions were doctors, lawyers, clergymen, and commissioned military officers. Today, the term is applied to estate agents, surveyors , environmental scientists,...
typically has a background relevant to the business in which they work, i.e., science, medicine, or engineering.