Regulatory Focus™ > News Articles > EMA Releases New Biosimilar Q&A Guidance

EMA Releases New Biosimilar Q&A Guidance

Posted 12 April 2012 | By Ansis Helmanis 

The European Medicines Agency (EMA) has published a new guidance document that brings together in a single place a number of regulatory and procedural questions on biosimilars. 

It provides an overview of the agency position on issues which are typically addressed during Pre-Submission Meetings. The agency notes that the document is for procedural advice only, and should be read in conjunction with the "Notice to Applicants" in the agency's Rules Governing Medicinal Products in the European Union. 


Read more:

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

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