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What to do after the MA approval in Europe?
Once a medicine is registered and authorized for marketing, the Marketing Authorization holder (MAH) has the obligation to properly monitor the continuous lifecycle management. Lifecycle management of medicines encompasses various activities, including:
- Post-marketing surveillance: after approval, data on the medicine's safety and effectiveness are collected through post-marketing surveillance. This ongoing monitoring is performed by the Pharmacovigilance (PhV) department of the company, which allows it to identify any adverse reactions or long-term safety issues that may arise after the product reaches the market. All the PhV activities are stated in the Regulation EU n. 1235/2010 and subsequent amendments.
- Product variations: these are considered as changes to the initial authorized dossier of medicines which can have different impacts on the information already evaluated from the authorities after the first authorization of the medicinal product. These changes can impact formulation, strength, quality aspects, packaging or safety information contained in the package leaflet. These variations may be required by pharmaceutical companies to improve product quality, respond to new safety information, or adjust to production needs. The variations are governed by Regulation (EC) n. 1234/2008 and can be classified in minor (IA/IB) or major changes (II); they require approval from the EMA to ensure compliance with regulatory standards.
- Product extensions: in some cases, there may be a need to extend the marketing authorization of a medicine beyond its initial approval. This extension can occur due to various reasons, including changes in the indications, dosages, or formulations of the medicine. This may include extending use to new pathologies, patient groups or routes of administration. The extensions are based on clinical and scientific data demonstrating the efficacy and safety of the drug for the proposed indication. EMA and national authorities carefully evaluate these requests to ensure that the extensive uses of the medicines meet the required quality and safety criteria. As per the variations, extensions are governed by Regulation (EC) No 1234/2008, as well.
Conclusion
Regulatory authorities, such as the EMA and national agencies, play a crucial role in evaluating requests for registration, extensions, and variations of medicines based on scientific principles and good practices. It is important for pharmaceutical companies to follow regulatory procedures and requirements, submitting accurate and comprehensive documentation to obtain authorization and maintain compliance throughout the lifecycle of the medicine. Harmonization of registration procedures at the European level facilitates trade and patient access to medicines across different EU countries. However, it is also crucial to consider the specificities of individual national markets, as some decisions may be made at the national level based on local considerations. Ultimately, registration, extensions, and variations of medicines in Europe represent a crucial process to ensure the safety and efficacy of available drugs for patients. Ongoing monitoring and pharmacovigilance contribute to ensuring that medicines are used safely and that information on their use is updated and accurate.
