Early Beginnings of Regulatory Affairs
19th Century: The industrial revolution led to mass production of goods, including pharmaceuticals and food products, necessitating regulation to protect public health.
Pure Food and Drug Act of 1906 (USA): One of the first significant regulatory laws, prohibiting interstate commerce of misbranded and adulterated foods, drinks, and drugs.
Key Milestones
1938 – Federal Food, Drug, and Cosmetic Act (FD&C Act):
Enacted in response to the sulfanilamide disaster, where a toxic solvent led to over 100 deaths.
Required proof of safety for new drugs before marketing.
1962 – Kefauver-Harris Amendments:
Triggered by the thalidomide tragedy causing birth defects.
Mandated proof of efficacy as well as safety.
Introduced Good Manufacturing Practices (GMP) and greater oversight of clinical trials.
Global Expansion
Formation of Regulatory Agencies:
FDA (Food and Drug Administration, USA): Evolved to oversee food, drugs, medical devices, and cosmetics.
EMA (European Medicines Agency): Established to harmonize regulations across the European Union.
MHRA (Medicines and Healthcare products Regulatory Agency, UK).
International Harmonization Efforts:
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH):
Established in 1990.
Aims to harmonize regulatory requirements globally.
Modern Era:
Digitalization: Electronic submissions (e.g., eCTD - electronic Common Technical Document) became standard.
Patient-Centric Approaches: Increased emphasis on patient safety and involvement in regulatory processes.
Emergence of New Technologies: Biotechnology, gene therapies, and personalized medicine presented new regulatory challenge.
Impact of Historical Events
Public Health Crises: Each major health crisis led to more stringent regulations and oversight.
Technological Advancements: Innovations required adaptation and evolution of regulatory frameworks.
Globalization: International trade necessitated harmonization and cooperation between regulatory bodies.