EMA publishes Updated Procedural Advice for Centralised Marketing Authorisations

The European Medicinal Agency (EMA) has recently published a revised version of its documents on procedural advice for centralised marketing authorisations and for generic products. The revision of theses "procedural advices" had become necessary to be in line with new pharmacovigilance legislation. The documents are based on questions and answers regarding the centralised procedure for conventional medicinal products, biosimilars (biological medicinal products which are similar to a biological medicine that has already been authorised) and generic / hybrid medicines (unlike pure generics, clinical or pre-clinical trials are necessary for hybrid medicinal products).

In total, four question-and-answer documents have been updated:

• European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
• European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
• EMA Procedural advice for users of the Centralised Procedure for Similar Biological Medicinal Products applications
• EMA Procedural advice for users of the centralised procedure for generic/hybrid applications

A tabular overview presenting all the revised or new questions/answers of each procedural advice document has been created to see at a glance the changes made.