Regulatory Focus™ > News Articles > New Q&A on Procedural Advice for Generic and Hybrid Product Applications Released by EMA

New Q&A on Procedural Advice for Generic and Hybrid Product Applications Released by EMA

Posted 26 January 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) released a new question and answer document on 25 January for applicants planning to use the Centralised Procedure to advance generic and hybrid product applications. The guidance "provides an overview of the EMA position on issues, which are typically addressed during the course of Pre-Submission Meetings."

EMA stresses the "importance of Pre-Submission Meetings with applicants", which should take place 6 months before the planned date of the application's submission. This ensures that the applicant receives timely procedural, regulatory and legal advice from EMA, which in turn allows for an expeditious approval process.

EMA is releasing 40 questions and answers to help applicants seeking to utilize the Centralised Procedure for generic and hybrid product applications. Q&A topics address, among other things, how to determine eligibility for the Centralized Procedure, dates for submission, associated submission fees, submission of samples, Active Substance Master File submission, evaluation timelines and how Pre-Submission Meetings are conducted at EMA.


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