Draft for Comments || Revised Guidelines on Good Manufacturing Practice (GMP) Clearance for Foreign Drug Manufacturers
All comments can be sent at [email protected] Deadline of submission of comments shall be by 21 November 2021. I. RATIONALE AND BACKGROUND Consistent with State policy under Section 3 of RA 9711 “(a) […]
Draft for Comments || GUIDELINES FOR THE CLASSIFICATION OF DEFICIENCIES OBSERVED DURING INSPECTION OF DRUG DISTRIBUTORS AND DRUG RETAIL OUTLETS
All comments can be sent at [email protected] Deadline of submission of comments shall be by 08 October 2021. I. RATIONALE Republic Act (RA) No. 3720, as amended by RA No. […]
Draft for Comments || Implementation of Abridged and Verification Review Pathways for New Drug, Initial Registration and Post-Approval Changes Applications of Drug Products, including Vaccines and Biologicals
All comments can be sent at [email protected] Deadline of submission of comments shall be by 05 October 2021. I. BACKGROUND As pharmaceutical supply chains become more globalized and complex, regulatory […]
Draft for Comments of ASEAN Pharmaceutical Regulatory Policy
All comments shall be sent via email at: [email protected], following the subject format: COMMENTS_DRAFT APRP. Deadline of submission of comments is on 26 September 2021. Attachments ASEAN PHARMACEUTICAL REGULATORY […]
Draft for Comments of Interim Guidelines for the Issuance of License to Operate (LTO) and Certificate of Product Registration (CPR) for Non-Medicated Veterinary Products/Cosmetics and Veterinary Medical Devices
All comments can be sent at [email protected] . Deadline of submission of comments shall be by 16 September 2021 (Friday). I. BACKGROUND In accordance with the provisions of the Republic […]
Draft for Comments of Revised Post-marketing Surveillance Requirements for New Drugs under Monitored Release
All comments can be sent at [email protected] . Deadline of submission of comments shall be by 31 August 2021. I. BACKGROUND On 15 March 1989, Department of Health Administrative Order […]
Draft for Comments of Banning of all Mercury-Containing Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes
All comments can be sent at [email protected].gov.ph . Deadline of submission of comments shall be by 14 August 2021. I. BACKGROUND The government signed the Instrument of Ratification of the […]
Draft for Comments of Adoption of the Post Marketing Alert System (PMAS) Requirements, Annex 5 of the ASEAN Medical Device Directive (AMDD)
All comments can be sent at [email protected] Deadline of submission of comments shall be by 07 August 2021 I. BACKGROUND / RATIONALE Republic Act No. 3720, otherwise known as the […]
Draft for Comments of Guidelines on the Licensing of Retailers of Medical Devices in the Philippines
All comments can be sent at [email protected] with copy furnished to [email protected]ov.ph . Deadline of submission of comments shall be by 24 July 2021. I. RATIONALE Republic Act No. 9711, […]
Revised Bureau Circular No. 2007-010 entitled Guidelines in the Initial Issuance and Renewal of License to Operate for Iron Rice Premix Manufacturer / Repacker / Importer and Updating of the Standards for Iron Rice Premix
OBJECTIVES: This Circular aims to provide updated guidelines and standards on the suitable level of iron in rice in the manufacture of iron-rice premix to help address iron deficiency anemia […]