On June 16, the Filipino FDA issued circular 2022-0045 named “Establishing Facilitated Registration Pathway for Drug Products”. This circular discussed how Reference Drug Regulatory Agencies (RDRA) can expedite drug, vaccine, and biologic approvals in the Philippines. If an RDRA has approved a drug, and the Filipino application is submitted within 3 years of the original filing, an abridged review is possible. If 2 RDRA’s have approved the drug, and the Filipino application is submitted within 3 years of approval, a verification review can be done. The quality of the original approvals must be identical to the Filipino FDA submission. A sworn assurance by the top regulatory official is needed to guarantee this. An abridged or verification application still requires the Filipino FDA to review some dossier sections and attachments. Abridged and verification reviews will take less than 45 days.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.pharma-iq.com/regulatorylegal/articles/philippines-fda-speed-covid-19-clinical-trial-approval-decisions-50-per-cent