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”
I. RATIONALE On 3 February 2023, the FDA Circular No. 2023-003 was issued with an aim to improve the regulatory compliance and regulatory efficiency by facilitating the review of non-standard […]
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.2024-002 || Recall and Withdrawal of the Classification and Registration of Topical Corticosteroids as Over-the-Counter and Household Remedy Drug
I. BACKGROUND It is the policy of the State to promote and protect the right to health of the people and instill health consciousness among them. In […]
FDA Circular No.2024-001 || Recall and Withdrawal of the Classification and Registration of Domperidone as Over-the-Counter Drug
I. BACKGROUND It is the policy of the State to promote and protect the right to health of the people and instill health consciousness among them. In the implementation of […]
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, […]
FDA Circular No.2023-012 || Recognition of Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring Services
I. BACKGROUND The Food and Drug Administration, though the Center for Device Regulation, Radiation Health, and Research (FDA -CDRRHR) is mandated to regulate radiation facilities and activities that use radiation […]
FDA Circular No.2023-011 || Updates and Amendments to the ASEAN Cosmetic Directive (ACD) as Adopted During the 37th ASEAN Cosmetic Committee (ACC) Meeting and its Related Meetings
I. BACKGROUND In 2005, the Department of Health (DOH) – Food and Drug Administration (FDA), then Bureau of Food and Drugs (BFAD), has adopted and implemented the Association of Southeast […]
FDA CIRCULAR No.2023-010 || Guidelines on the Conduct of the Food and Drug Administration Trainings and Seminars Offered by the FDA Academy to the External Stakeholders
I. RATIONALE The Food and Drug Administration (FDA) through the FDA Academy conducts training programs for its stakeholders on health establishment and product regulations based on the provisions of Republic […]
FDA Circular No.2023-009 || Adoption of 2015 Philippine Dietary Reference Intakes (PDRI) Percent Recommended Energy Intakes/Recommended Nutrient Intakes (%REI/RNI) as the New Dietary Standard of All Prepackaged Processed Food Repealing Bureau Circular No. 16 s. 2005 entitled “Adopting the 2002 Recommended Energy and Nutrient Intakes as the New Dietary Standard”
I. RATIONALE It is a policy of the State as embodied in Article II, Section 15 of the 1987 Constitution to protect and promote the right to health of the […]