Regulatory affairs
Regulatory affairs
Regulatory affairs (pronounced: /rɛɡjʊˈleɪtɔːri əˈfeəz/) 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).
Etymology
The term "regulatory affairs" is believed to have originated in the United States in the 1960s, following the introduction of the Kefauver Harris Amendment Act in 1962 which mandated that all pharmaceutical products must be proven both safe and effective. This led to the creation of regulatory affairs departments in pharmaceutical companies, and the term became widely used.
Related terms
- Pharmaceuticals: A type of medicinal drug or preparation.
- Medical devices: Any device intended to be used for medical purposes.
- Energy: The capacity of a physical system to perform work.
- Banking: The business activity of accepting and safeguarding money owned by other individuals and entities, and then lending out this money in order to conduct economic activities such as making profit or simply covering operating expenses.
- Healthcare industries: Industries that provide goods and services to treat patients with curative, preventive, rehabilitative, and palliative care.
- Biologics: Products that are produced from living organisms or contain components of living organisms.
- Functional foods: Foods claimed to have a health-promoting or disease-preventing property beyond the basic function of supplying nutrients.
External links
- Medical encyclopedia article on Regulatory affairs
- Wikipedia's article - Regulatory affairs
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