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Posted 18 March 2013 | By Alexander Gaffney, RAC,
The European Medicines Agency (EMA) has announced that it has simplified the process by which marketing authorization applications (MAAs) are submitted to the agency, reducing the number of applications that marketing authorization holders (MAHs) need to submit during the centralized procedure.
The changes comes just as EU regulators are in the midst of implementing the pharmacovigilance legislation, an EU-wide set of requirements intended to make it easier to track and report post-marketing safety events affecting medicines and patients.
Under the old submission system, MAH's would have to submit multiple copies of a regulatory dossier to various entities.
Under the new submission system, sponsors will be responsible for submitting one copy of their submission to the EMA (Committee for Medicinal Products for Human Use, Committee for Advanced Therapies, and/or the Pharmacovilgilance Risk Assessment Committee) and one copy to each EU member state.
Those applications may be submitted via either the electronic common technical document (eCTD) or a DVD/CD ROM using the relevant submission portals.
In the near future, EMA said it hopes to introduce an electronic submission system common to and accepted by all EU member states, which would have the effect of simplifying the submission process even further.
Tags: PRAC, Centralized Procedure, CAT, Centralised Procedure, application, Latest News, CHMP, submission, EU