Regulatory Focus™ > News Articles > EMA Releases New Summary of Biosimilar Regulatory Procedures

EMA Releases New Summary of Biosimilar Regulatory Procedures

Posted 11 April 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) released a new regulatory procedure document on biosimilar medicines which it hopes will consolidate a number of regulatory and procedural questions already existing in a number of locations.

The document "complements existing guidance documents on innovative products and should be read in conjunction with the Agency's scientific guidelines on biosimilars," EMA said in a press release.

The document lists 43 questions and answers related to the development and regulatory submission of biosimilar products.

Read more:

EMA - European Medicines Agency publishes new document on regulatory procedural advice on similar biological medicines

EMA - EMA Procedural advice for users of the centralised procedure for similar biological medicinal products applications 

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