The Filipino FDA has proposed a shorter review time for drugs if their clinical studies are completed successfully and approved by the US FDA, PMDA, TGA, EMA, and UK/Canadian FDAs. These approvals would only apply for drugs that can help with health emergencies like infectious diseases, HIV/AIDS, cancer, or rare diseases. By doing this, the Filipino FDA hopes to expedite patient access to new drugs.
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.fda.gov.ph/draft-for-comments-guidelines-on-regulatory-reliance-on-the-conduct-of-clinical-trials-in-the-philippines-2/