In Portugal, the regulatory authority responsible for the approval of generic drugs is the Infarmed - National Authority of Medicines and Health Products. The approval process for generic drugs in Portugal generally follows the guidelines and regulations set by the European Medicines Agency (EMA) and the European Union.
The regulatory timeline for generic drug approval typically consists of the following stages:
1. Pre-submission phase: The generic drug manufacturer conducts research and development to demonstrate the bioequivalence of the generic product with the reference (innovator) drug. This phase can take several years.
2. Application submission: Once the generic drug is ready for approval, the manufacturer submits a Marketing Authorization Application (MAA) to Infarmed. The application should contain comprehensive data on the safety, quality, and efficacy of the generic drug.
3. Validation: Infarmed reviews the submitted application to ensure that all necessary documents and information are provided. This process usually takes a few weeks.
4. Evaluation: The evaluation process involves a thorough assessment of the data provided in the application. Infarmed evaluates the scientific and clinical data to ensure the generic drug's safety and efficacy.
5. Approval decision: Upon completion of the evaluation, Infarmed will make a decision regarding the approval of the generic drug. If the drug meets all regulatory requirements, it will be granted marketing authorization.
The timeline for generic drug approval can vary, but it typically takes around 12 to 18 months from the submission of the application to the approval decision. Delays can occur due to additional data requests, clarification, or potential concerns about the drug's safety or efficacy.
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