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The European Medicines Agency (EMA) is exploring an improved approach for biosimilar medicine development and evaluation, while upholding strict European Union (EU) safety standards. The is outlined in a draft reflection paper biosimilar development. Its aim is to reduce the amount of clinical data required for the development and approval of...

Following the positive evaluation of a plasma master file (PMF) under the PMF certification scheme, the European Medicines Agency (EMA) issues a certificate of compliance with European legislation which is valid throughout the European Union. EMA publishes the list of all the issued PMF certificates.