European Regulatory Procedures 2017
EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines. EMA's success is based on cooperation within the European medicines regulatory network - a unique partnership between the European Commission,...
Validation, Verification and Transfer o...
Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equival...
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