Introduction to the organisational structure of US and EU regulatory agencies
- FDA is an agency within the U S Department of Health and Human Services
- FDA is the federal agency responsible for protecting the public health by assuring the safety, efficacy and security of
- human and veterinary drugs,
- biological products, medical devices,
- food supply, cosmetics and
- Products that emit radiation.
- FDA’s organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency:
- Global Regulatory Operations and Policy
- Medical Products and Tobacco
Office of Medical Products and Tobacco: It provides high-level coordination and leadership across the centres for drug, biologics, medical devices and tobacco products. It also oversees agency’s special medical programs.
- Centre for Drug Evaluation and Research
- Centre for Biologics Evaluation and Research
- Centre for Devices and Radiological Health
- Centre for Tobacco Products
- Oncology Center of Excellence
- Office of Special Medical Programs
- Office of Medical Products and Tobacco
- Office of the Centre Director
- Office of Communications
- Office of Compliance
- Office of Generic Drugs (OGD)
- Office of Management
- Office of Medical Policy
- Office of New Drugs
- Office of Pharmaceutical Quality (OPQ)
- Office of Regulatory Policy
- Office of Strategic programs
- Office of Surveillance and Epidemiology
- Office of Translational Sciences
The European Economic Area (EEA)
- EEA includes EU countries and EFTA member states
- It allows them to be part of the EU’s single market.
European Commission (EC):
- Institution of European union
- Responsible for proposing legislation, implementing decisions, upholding EU treaties & managing day-to-day business of EU.
European Free Trade Association (EFTA):
Is an intergovernmental organisation set up for the promotion of free trade and economic
integration to the benefit of its four Member States: Iceland, Liechtenstein, Norway,
The European Union (EU) is an economic and political union of 27 countries.
- European Medicines Agency (EMA)
- Protection & promotion of human & animal health by evaluation of medicines.
- Publishes guidelines on quality, safety and efficacy requirements (Safety monitored
through a pharmaco-vigilance network).
- Contributes to harmonisation of regulatory standards at international level.
Seven scientific committees of EMA
|Committee for Medicinal Products for Human Use||CHMP|
|Committee for Medicinal Products for Veterinary Use||CVMP|
|Committee for Orphan Medicinal Products||COMP|
|Committee on Herbal Medicinal Products||HMPC|
|Pharmacovigilance Risk Assessment Committee||PRAC|
|Committee for Advanced Therapies||CAT|
- Heads of Medicines Agencies (HMA):
- Is a network of the heads of the National Competent Authorities (NCA) whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the EEA
Certificate courses in Regulatory Affairs at IPM
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