All Centralised Procedure submissions should be made via EMA eSubmission Gateway/Web Client only. Committee for Advanced Therapies (CAT) members nominated by the European …

In June 1999, a contract governing an annual CAP Sampling & Testing Programme was signed by the European Medicines Agency (EMA) and the EDQM. The EMA is the sponsor of the …

A medicine with a single marketing authorisation issued by the European Commission and valid across the European Union. More information can be found under ' Authorisation of medicines '.

To achieve these objectives, the Agency set up a sampling and testing programme involving the Scientific Committees at EMEA, EDQM, the inspectorates and OMCLs of the EEA countries to …

2024年12月7日 · Following optional use over the past two years, EMA now strongly recommends the use of the PLM Portal web-based eAF for all CAPs variations. Initially communicated in …

欧洲药品管理局（ema）负责在泛欧洲范围内，评估和监督药品的集中上市许可（cap），是制定全球药品监管标准的重要力量。 受英国脱欧影响，原本设置在伦敦的EMA已于2019年3月迁 …

2004年5月20日 · Companies wishing to market a medicinal product that is eligible for the centralised authorisation procedure, submit their application directly to the European …

The Centrally Authorised Product (CAP)sampling and testing programme is a risk-based, public and animal health protection surveillance programme operating in the EU/EEA. It is under the …

Updated CAPS data has been loaded to the web-based eAF, where users will be able to see this data in their forms. This step is part of European Medicines Regulatory Network’s transition …

In the European Union (EU), there are two main routes for authorising medicines: a centralised route and a national route. Check our interactive timeline for an overview of all stages in the …