Introduction to the organisational structure of US and EU regulatory agencies
US-FDA
- 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:
- Foods
- Global Regulatory Operations and Policy
- Operations
- 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
CDER Offices
- 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
EUROPE:
The European Economic Area (EEA)
- EEAincludes EU countries and EFTA member states
- It allows them to be part of theEU’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,
Switzerland
EU countries
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 |
| Pediatric Committee | PDCO |
| 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
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