FDA Philippines Issues Draft on Classification of Pharmaceutical Products for Human Use

Classification of Pharmaceutical Products Intended for Human Use – Philippines

October 6, 2025

The Philippines FDA has released updated guidelines outlining the classification and reclassification of pharmaceutical products for human use. The regulation introduces pharmacist-only non-prescription medicines, establishes criteria based on safety, medical supervision, and risk of misuse, and details a stepwise reclassification process led by FDA safety evaluations. It mandates updated labeling, including Patient Information Leaflets (PILs) for non-prescription products, and enforces post-approval change (PAC) submissions for reclassified products. Only non-prescription drugs may be publicly advertised. Stakeholders are invited to submit comments by October 31, 2025.