Regulatory Updates

The Food and Drug Administration Policy and Planning Service (FDA PPS) of the Philippines has issued draft guidelines for comments and input from industry stakeholders covering the categorization of borderline health products under the jurisdiction of the FDA. The FDA’s jurisdiction covers multiple product categories such as devices, cosmetics, drugs,

The Food and Drug Administration (FDA) of the Philippines has issued a draft regulation on IVD market authorizations. The draft is open for comments from industry stakeholders until 7 February 2022. Here are the main points of the draft regulation issued by the FDA: New registration, notification and listing certificates

The Philippines FDA now accepts applications for registration for COVID 19 Self-Test Kits. The Philippines FDA issued Advisory No. 2021-3604 on 29 December 2021 regarding the start of acceptance of submissions for Special Certification of COVID-19 self-test kits that will be effective as of 6 January 2022, in accordance with the

The Food and Drug Administration (FDA) of the Philippines has issued an amendment to FDA Circular No. 2021-023 extending the current validity of market authorizations, Special Certification, for COVID-19 Test Kits, from 31 December 2021 to 31 January 2022. This extension is valid ONLY for COVID-19 Test Kits whose marketing