Philippine FDA consults on accelerated registration of WHO-prequalified products

The Philippine Food and Drug Administration (FDA) is holding a consultation on its draft implementing guidelines on the collaborative procedure for the accelerated registration of World Health Organization (WHO)-prequalified pharmaceutical products and vaccines.

WHO issued a collaborative review procedure in 2013, and updated the text in 2016, to enable national regulatory agencies to leverage its scientific assessments to enhance their premarketing evaluation and registration systems. The collaboration gives national regulators access to privately held assessment outcomes to inform their decision-making and to educate their staff. FDA wants to make use of the system due to “the current resource constraints affecting drug regulation.”

FDA’s draft implementing guidelines apply to all FDA-licensed drug manufacturers, traders and distributors that have WHO-prequalified pharmaceutical products and vaccines and are seeking registration and post-approval changes.

In practice, FDA is adopting the WHO collaborative registration procedure as a registration pathway. The agency is asking companies that want to use the pathway to first ensure they have given WHO consent to share information with national regulators. The pathway is limited to products that are identical in quality and target the same indications as the ones covered by the WHO review. Applications filed under other facilitated review pathways, such as abridged review, cannot also benefit from the WHO procedure.

The implementing guideline also outlines the documentation that FDA expects applicants to submit, including country-specific paperwork such as foreign good manufacturing practices issued by FDA, labeling materials consistent with requirements in the Philippines and stability data generated in the hot and very humid IVb climatic zone.

After receiving a valid new product application, FDA will take up to 90 calendar days to evaluate the submission using the information provided by WHO. FDA will write to the applicant if it discovers it needs more information. The review time for postapproval changes is 30 days. Once the Philippine regulatory has reached a decision, it has 30 calendar days to inform WHO.

FDA is accepting feedback on the draft guidelines until 17 June. Once finalized, FDA will publish the text and bring it into force 15 calendar days after publication. The agency plans to review the order after three years. RAPS.org