October 7, 2013

The Food and Drug Administration Philippines recently issued a memo implementing a paperless submission of registration.  FDA Memorandum Circular 2013-038 aims to render fast, efficient, convenient and reliable frontline service.

FDA aims to have a paperless registration of product and company registration. For companies planning to register products there is an ongoing pilot test of the new process for registration to prepare the industry of the new process. Submission of application will be on schedule basis. Applicants will have to send an application for schedule of submission via email to . Schedule will be set by FDA as per the quota that they will implement per Center. Technical dossier file of the product will be saved in a Universal Serial Bus (USB) or Flash drive and will be brought to FDA on the scheduled date of submission. FDA will then transfer the file on their system for process and evaluation.

Technical dossier requirements are still the same except for the Drug Product registration which FDA are now implementing the ASEAN Common Dossier Template Guideline for application of pharmaceutical product.

Full implementation of the memorandum will take effect on January 2014.

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