Drug approval is the process of formally authorizing and adding a drug to the list of approved drugs that may be sold on the market. This procedure is subject to the requirements of the regulatory authorities and the laws of the respective countries or regions for which they are being approved. It is mandatory for all drugs intended for use on patients. Efficacy (German translation: Wirksamkeit), safety and pharmaceutical quality of a drug must be verified by the regulatory authority before the drug can be granted marketing authorization.

The most important steps in the drug approval process are:

• Application: A pharmaceutical company that develops a drug submits a New Drug Application (NDA; British English: Marketing Authorisation Application, MAA; German: Zulassungsantrag) to the competent regulatory authority. The application must include all the necessary documentation, including data on the safety, efficacy and quality of the drug.
• Evaluation of the documents: The regulatory authority conducts a thorough evaluation of the submitted documentation, including the results of clinical trials (German translation: klinische Prüfungen), manufacturing and quality control data.
• Granting approval: If the drug meets all requirements and regulations, the regulatory authority issues a marketing authorization that allows the pharmaceutical company to manufacture and sell the drug.
• Drug labeling: As soon as a drug has been approved, all the necessary data must be stated on the packaging and the instructions for use and information for healthcare professionals must be available.
• Pharmacovigilance: Once a drug has been approved, the regulatory authorities continue to monitor its safety and efficacy on the market. This may include the obligation to report adverse drug reactions and a review of the drug data in regular intervals.

Drug approval is necessary to ensure the quality, efficacy and safety of the drugs on the market and to protect patients’ interests. It also facilitates quality control and ensures that drugs are in compliance with laws and regulations.

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