![]() developing EU-wide procedures on GMP inspections and related activities.ensuring common interpretation of EU GMP requirements and related technical issues.coordinating the preparation of new and revised guidance on GMP.The Agency also plays a key role in coordinating and harmonising GMP activities at an EU level. The Agency has a coordinating role for GMP inspections of manufacturing sites for medicines whose marketing authorisation in the EU is submitted through the centralised procedure or as part of a referral procedure. Guidance for medicine developers and companies on COVID-19: Regulatory expectations and flexibility. ![]() The guidance was agreed by the GMP/GDP Inspectors Working Group coordinated by EMA, the European Commission, the European medicines regulatory network and endorsed by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.
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