Abridged review refers to a limited independent assessment of specific parts of the dossier, or submission for suitability of use under local conditions and regulatory requirements while relying on prior assessment from an RDRA to inform the local decision. The review is based on a complete assessment report, including question and answer documents, and the dossier including the stability data.
Verification review refers to an assessment process by which the submission has been evaluated and approved by at least two (2) RDRAs, and the FDA only validates the submission and ensures that the product conforms to the registration conditions, standards, and requirements as approved by the RDRAs.
This guideline aims to provide details on the facilitated registration pathways (FRPs) through abridged review or verification review of new drugs, including vaccines and biologicals.
This guide covers applications of new drugs including vaccines, and biologicals as defined in Section IV below, and shall apply to all licensed drug distributors intending to place in the local market or apply for post-approval changes of drug, vaccine, and biological products with existing and valid approval/s from RDRA/s.
The turnaround time shall start after receipt of the proof of payment with the complete application dossier.
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