Draft for Comments of Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”
All comments can be sent at [email protected] Deadline of submission of comments shall be by 14 May 2021. I.BACKGROUND/RATIONALE On 4 January 2021, FDA Circular (FC) No. 2021-002 was […]
Draft for Comments of Guidelines for the Use of the Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Traders and Distributors including Wholesalers, Importers, and Exporters of Medical Devices, Equipment or Devices Used for Treating Sharps, Pathological and Infectious Waste and Water Treatment Devices/Systems
I. BACKGROUND Streamlining of License to Operate (LTO) application procedures is one of the key web infrastructures that the Food and Drug Administration (FDA) is undertaking. This is in […]
Draft for Comments of Guideline for the Use of the Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Traders and Distributors including Wholesalers, Importers, and Exporters of Processed Food Products, Food Supplements, Bottled Water, and Iodized Salt
All comments can be sent at [email protected] Deadline of submission of comments shall be by 25 March 2021. I.BACKGROUND In order to gear towards an efficient operationalization of Food and […]
Draft for Comments of Interim Guidelines on the Issuance of Certificate of Accreditation and Inspection of Bioequivalence (BE) Testing Centers
All comments can be sent at [email protected] Deadline of submission of comments shall be by 20 January 2021. Attachment:-> Interim Guidelines on the Issuance of Certificate of Accreditation and Inspection of […]
Draft for Comments of Supplement to FDA Circular No.2014-016 Implementing Guidelines Administrative Order 2013-0022,” on the Renewal of cGMP Clearance
All comments can be sent at [email protected] Deadline of submission of comments shall be by 08 January 2021. Attachment:->Draft for Comments – Supplement to FDA Circular No.2014-016 Implementing Guidelines AO2013-0022 on […]
Draft for Comment of Application for Labeling Compliance of Drug Products under Maximum Drug Retail Price
All comments can be sent at [email protected] Deadline of submission of comments shall be by 08 January 2021. I. BACKGROUND/RATIONALE Rule 31, Section 1 of the Joint DOH-DTI-IPO-BFAD Administrative Order […]
Draft for Comment of Implementing Guidelines of Joint Department of Health (DOH) and Department of Agriculture (DA) Administrative Order No. 2020-001: Re-Adoption of Joint DOH and DA Administrative Order No. 2013-0026
All comments can be sent at [email protected] Deadline of submission of comments shall be by 3 December 2020 INTRODUCTION Cognizant of the authority of the Food and Drug Administration […]
Guidelines on Compliance with Section 35 (b) of Republic Act No. 11223 (Universal Health Care Act) by All Drug, Medical Device, Biological and Medical Supplies Manufacturers to Submit Reports on Disclosure of Financial Relationships with Health Care Providers and Health Care Professionals
All comments can be sent at [email protected] BACKGROUND The 1987 Philippine Constitution declares that it is the policy of the State to protect and promote the right to health of the […]
Draft Guidelines on Facilitated Registration of Drugs Products, Vaccines and Biologicals: Abridged Review, Verification Review, and Collaborative Procedure
All comments can be sent at [email protected] Deadline of submission of comments shall be by 28 August 2020. OBJECTIVES The general objective of this Administrative Order is to provide facilitated registration […]
Draft for Comments of Implementing Guidelines for Imported Pharmaceutical Products from a Foreign Trader
All comments can be sent at [email protected] Deadline of submission of comments shall be by 21 August 2020. OBJECTIVES This Circular aims to: Provide guidelines to reflect the actual manufacturer of […]