legemiddelgodkjenning

Legemiddelgodkjenning, or drug approval in English, refers to the formal process by which a regulatory authority evaluates a new medicine to determine if it is safe and effective for its intended use. This process is crucial for ensuring public health by preventing the marketing of harmful or ineffective drugs.

In most countries, a dedicated agency is responsible for drug approval. For example, the European Medicines Agency (EMA) handles approvals for the European Union, while the Food and Drug Administration (FDA) performs this function in the United States. In Norway, the Norwegian Medicines Agency (Statens legemiddelverk) plays a key role, often working within the framework of the EMA for medicines intended for the EU market.

The approval process typically involves extensive preclinical and clinical trials conducted by the pharmaceutical company seeking approval. Preclinical studies assess the drug's safety and biological activity in laboratory settings and animals. Clinical trials, conducted in humans, are divided into phases. Phase I trials evaluate safety and dosage in a small group of healthy volunteers. Phase II trials assess efficacy and side effects in a larger group of patients with the target condition. Phase III trials confirm efficacy, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug to be used safely.

Once these trials are completed, the company submits a comprehensive dossier of data to the regulatory agency. Experts at the agency then meticulously review all submitted information. They assess the drug's benefits against its risks, the manufacturing process for quality control, and the proposed labeling. If the agency concludes that the drug is safe and effective for its intended use, and that its benefits outweigh its risks, it grants marketing authorization, allowing the drug to be made available to patients. The approval process is rigorous and data-driven, prioritizing patient safety.