##  [FDA Philippines Issues Draft on Classification of Pharmaceutical Products for Human Use](/index%2ephp/mandate/fda-philippines-issues-draft-on-classification-of-pharmaceutical-products-for-human-use) 

October 6, 2025

**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.



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Source

[https://www.fda.gov.ph/draft-for-comments-classification-of-pharmaceutical-prod…](https://www.fda.gov.ph/draft-for-comments-classification-of-pharmaceutical-products-intended-for-human-use/)

[https://www.fda.gov.ph/wp-content/uploads/2025/10/Draft-for-Comments-Classifica…](https://www.fda.gov.ph/wp-content/uploads/2025/10/Draft-for-Comments-Classification-of-Pharmaceutical-Products-Intended-for-Human-Use.pdf)

<https://www.fda.gov.ph/wp-content/uploads/2025/10/Annex-A.pdf>

 

 

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[Food and Drug Authority-Philippines](/index%2ephp/mandate-by-ha/food-and-drug-authority-philippines)

 

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[Country Regulatory Affairs](/index%2ephp/mandate-by-function/country-regulatory-affairs)