[REGULATORY AGENCIES AND ESTABLISHMENT LICENSING] RA 9711 - DOH Issuance

AO No. 2014- 0034

Licensing of Drug Establishments

AO No. 2014- 0034 (Licensing of Drug Establishments)

Updated and streamlined the rules for securing a License to Operate (LTO) for drugstores, manufacturers, and distributors.

AO No. 2020- 0017

Revised Unified Licensing Guidelines

AO No. 2020- 0017 (Revised Unified Licensing Guidelines)

Established the Unified Licensing Requirements for all FDA centers, facilitating the "Ease of Doing Business."

AO No. 2020- 0045

Facilitated Registration Pathways

AO No. 2020- 0045 (Facilitated Registration Pathways)

Introduced the Abridged, Verification, and Collaborative review pathways for drug products to speed up local availability.

AO No. 2019- 0019

Licensing for Cosmetics and HUHS

AO No. 2019- 0019 (Licensing for Cosmetics and HUHS)

Reinstated licensing requirements for establishments involved in Household/Urban Hazardous Substances (HUHS).

AO No. 2013- 0027

Good Distribution and Storage Practices

AO No. 2013- 0027 (Good Distribution and Storage Practices)

Mandated the adoption of WHO standards for GDP and GSP to ensure drug quality throughout the supply chain.

AO No. 2024- 0015

Updated Regulatory Coverage

AO No. 2024- 0015 (Updated Regulatory Coverage)

Revised the scope of health products to explicitly include refurbished medical devices and orphan drugs