Drug approval
Drug Approval
Drug approval (/drʌg əˈpruːvəl/) is a process that a pharmaceutical drug must undergo before it is legally available for patients to use. This process is overseen by regulatory authorities to ensure the safety, efficacy, and quality of the drug.
Etymology
The term "drug approval" is derived from the English words "drug", which refers to a substance used for medical treatment, and "approval", which means the action of officially agreeing to something or accepting something as satisfactory.
Process
The drug approval process typically involves several stages, including preclinical testing, clinical trials, and post-marketing surveillance.
- Preclinical testing: This stage involves laboratory experiments and animal testing to assess the safety and efficacy of the drug.
- Clinical trials: If the results of preclinical testing are promising, the drug proceeds to clinical trials, which are conducted in three phases. Phase I trials involve a small group of healthy volunteers to assess the drug's safety and dosage. Phase II trials involve a larger group of patients to assess the drug's efficacy and side effects. Phase III trials involve a large group of patients to confirm the drug's efficacy, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug to be used safely.
- Post-marketing surveillance: After a drug is approved and marketed, it is monitored for any adverse effects not detected during clinical trials.
Regulatory Authorities
Drug approval is overseen by regulatory authorities in each country. The Food and Drug Administration (FDA) is the regulatory authority in the United States, while the European Medicines Agency (EMA) is responsible for drug approval in the European Union. Other regulatory authorities include the Therapeutic Goods Administration (TGA) in Australia and the Health Canada in Canada.
Related Terms
- Investigational New Drug (IND): An application submitted to the FDA to begin clinical trials for a new drug.
- New Drug Application (NDA): An application submitted to the FDA for the approval of a new drug.
- Biologics License Application (BLA): An application submitted to the FDA for the approval of a biologic, such as a vaccine or blood product.
- Generic Drug: A drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use.
External links
- Medical encyclopedia article on Drug approval
- Wikipedia's article - Drug approval
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