Legislation, regulations and guidances
| Regulation of therapeutic goods in the United States |
|---|
 |
|
Prescription drugs Over-the-counter drugs |
European Union
- Directive 2001/20/EC
- Directive 2001/83/EC
- Directive 2005/28/EC
- Directive 65/65/EEC
- Directive 93/41/EEC
- Directive 95/46/EC on the protection of personal data
United States
- Federal Food, Drug, and Cosmetic Act (FD&C) – gives authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.
- Kefauver Harris Amendment – requires drug manufacturers to provide proof of the effectiveness and safety of drugs before approval.
- Prescription Drug User Fee Act – allows the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
- Title 21 of the Code of Federal Regulations – the section of Federal regulations that interprets and enforces FD&C.
- Title 21 CFR Part 11 – defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
- Health Insurance Portability and Accountability Act (HIPAA) – Title II of HIPAA addresses the security and privacy of health data, including data collected from subjects in clinical research.
Other
- Declaration of Helsinki (United Nations)
- Food and Drugs Act (Canada)
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (European Union, Japan, and United States)