{"entity":{"id":"fda-philippines","kind":"institution","name":"Food and Drug Administration, Philippines","aka":["FDA Philippines","Philippine FDA"],"tldr":"The medicines regulator of the Philippines, part of the Department of Health. It registers new medicines on a full review or on shorter reliance routes that use an approval by a reference regulator, and the 2019 cancer law requires it to license cancer medicines through a dedicated process taking no more than a year.","summary":"The Food and Drug Administration of the Philippines, at Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa, regulates medicines under Republic Act 3720 as amended by the FDA Act of 2009 (Republic Act 9711). Section 23 of the National Integrated Cancer Control Act of 2019 requires it to create a dedicated and streamlined process, not exceeding one year, for licensing innovator and generic cancer medicines, subject to quality checks and minimum standards such as approval and use for cancer treatment in other countries. Its Director General sits on the National Integrated Cancer Control Council.\n\nDepartment of Health Administrative Order 2020-0045 established facilitated registration pathways, implemented for new drugs by FDA Circular 2022-004. FDA Circular 2022-004-A, dated 15 February 2024, extended them to generic drugs: an abridged review is available when a product has been approved by one reference drug regulatory agency, and a verification review when it has been approved by at least two. Reference agencies must operate at World Health Organization maturity level 4, and the amendment added Korea's Ministry of Food and Drug Safety and the Saudi Food and Drug Authority as the fifteenth and sixteenth on the list. Each application needs a sworn assurance that the product is the same in all respects as the one the reference agency approved. The US Commercial Service summarised the target times in April 2023 as no more than 45 working days for an abridged review and 30 for a verification review, counted from proof of payment with a complete dossier; the circular's own text was not read for this record.\n\nThe coordinates are approximate for Alabang, not the street address.","asOf":"2026-11-04","links":[{"label":"FDA Circular 2022-004-A, 15 February 2024 (PDF, scanned)","url":"https://www.fda.gov.ph/wp-content/uploads/2024/02/FDA-Circular-No.2022-004-A.pdf"},{"label":"US Commercial Service: Philippines pharmaceuticals, 26 April 2023","url":"https://www.trade.gov/market-intelligence/philippines-pharmaceuticals"},{"label":"Republic Act 11215, Section 23 (Lawphil)","url":"https://lawphil.net/statutes/repacts/ra2019/ra_11215_2019.html"},{"label":"Food and Drug Administration, Philippines","url":"https://www.fda.gov.ph"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["doh-philippines","philippine-hta-council","philhealth"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"city":"Muntinlupa","country":"PH","lat":14.418,"lng":121.041,"institutionType":"government","website":"https://www.fda.gov.ph","programs":["Drug registration","Abridged review (one reference regulator) and verification review (two)","Facilitated registration pathways for new and generic drugs (FDA Circulars 2022-004 and 2022-004-A)"]},"route":"/institutions/fda-philippines/","neighbours":{"institution":[{"id":"doh-philippines","kind":"institution","name":"Department of Health, Philippines","route":"/institutions/doh-philippines/"},{"id":"philippine-hta-council","kind":"institution","name":"Health Technology Assessment Council, Philippines","route":"/institutions/philippine-hta-council/"},{"id":"philhealth","kind":"institution","name":"Philippine Health Insurance Corporation (PhilHealth)","route":"/institutions/philhealth/"}]}}