FDA Circular No.2023-003-A || Amendment to FDA Circular No. 2023-003, entitled, “Guidelines on the Filing and Submission of Acceptable Variations on Protocols and Non-standard Protocols for the Review and Pre-Approval by the Food and Drug Administration Prior to the Conduct of Bio-efficacy Test Studies of Household Pesticides for the Purposes of Securing a Certificate of Product Registration”

Published at The Manila Times on 8 June 2024 I. RATIONALE On 3 February 2023, the FDA Circular No. 2023-003 was issued with an aim to improve the regulatory compliance […]

FDA Circular No.2024-003 || Extension of the Regulatory Flexibility for Class B, C and D Medical Devices that are Not Included in the List of Registrable Medical Devices Based on FDA Circular No. 2020-001-A entitled “Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements””

I. RATIONALE FDA Circular (FC) No. 2021-002-A was issued on 9 August 2021 to provide guidelines on the application for a Certificate of Medical Device Notification (CMDN) and a Certificate […]

FDA Circular No.2021-021-A || Extension of the Transitory Provision of FDA Circular No. 2021-021 Entitled “Guidelines on the Licensing of Retailers of Medical Devices in the Philippines” for FDA Licensed Manufacturers, Traders or Distributor (Importers, Exporters and/or Wholesalers) of Medical Devices that Also Sell or Intend to Sell Medical Devices to the General Public

I. RATIONALE On 8 May 2020, Administrative Order No. 2020-0017[1] was issued to simplify the requirements and processes for initial, renewal, and variation of LTO applications for health product establishments […]

FDA Circular No.2022-004-A || Amendment to FDA Circular No. 2022-004 entitled “Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 Establishing Facilitated Registration Pathways for Drug Products including Vaccines and Biologicals” to include Generic Drug Registration Applications and update the list of Reference Drug Regulatory Agencies

In the continuous effort to streamline regulatory processes and adopt good reliance practices in the Food and Drug Administration (FDA) pursuant to Republic Act (RA) No. 3720 or the Food, […]