PCRP invited by FDA for Public Consultation on Pharmacovigilance and Industry Dialogue

Philippine FDA invited professional organizations and societies to a public consultation to discuss the proposed FDA Circular entitled “Guidance for Industry – Pharmacovigilance Requirements”. This meeting was held last 16 July 2019 at the FDA Main Building in Muntinlupa City.

PCRP was present during this meeting that was chaired by FDA’s Atty. Katherine Austria- Lock, the Officer-In-Charge of the Center for Drug Evaluation and Research. Atty. Lock presented the draft of the FDA Circular that will be applicable to all manufacturers and market authorization holders (MAH) of all registered drugs and biological products for human use. The proposed guideline will not apply to medical centers, hospitals and other health institutions, pharmacies, RONPDs, private practitioners and healthcare professionals, public health programs and the general public.

The Circular provides guidance to industry on the submission of safety information to the Food and Drug Administration from the time of application for product registration and post-marketing phase of registered products. The Circular is expected to be issued within this year.

PCRP representatives who attended were Rodmar C. Pulido and Grace Mendoza. They were joined later by Jenny Arellano in attending a subsequent FDA forum with Usec. Rolando Enrique D. Domingo, who called for a dialogue with industry stakeholders.

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