{"entity":{"id":"thai-fda","kind":"institution","name":"Food and Drug Administration, Thailand","aka":["สำนักงานคณะกรรมการอาหารและยา","อย.","Thai FDA"],"tldr":"Thailand's medicines regulator, part of the Ministry of Public Health. It registers new medicines on a full or a shortened review that relies on another regulator's assessment, and its drug policy division keeps the National List of Essential Medicines.","summary":"The Food and Drug Administration of the Ministry of Public Health registers medicines in Thailand. Its own slides for the 11th Thailand-Japan Symposium, citing the public manual for modern drug registration of 1 September 2025, give target times in working days: 220 for a full assessment of a new drug or new biologic, 154 for an abridged assessment that relies on an unredacted assessment report from a reference regulator, and 90 for the collaborative registration procedures for medicines prequalified by the World Health Organization or approved by a stringent regulator; vaccines take up to 280 days on full assessment. The reliance route accepts reports submitted and certified by sponsors, reports certified by Japan's PMDA, or reports sent by Australia's TGA under bilateral arrangements, and the Thai FDA keeps the right to revert to a full assessment. The slides cite a 2025 case in which a new Alzheimer's medicine was approved in 179 working days against the 220-day standard through cooperation with the PMDA.\n\nIts National Drug Policy Division, at 88/24 Tiwanon Road, Nonthaburi, serves the National Drug System Development Committee, which issues the National List of Essential Medicines (the list in force, as archived on 10 July 2026, is dated 12 February 2026; it replaced the list of 4 January 2024, amended 30 August 2024). The list's restricted sub-list R2, formerly called list E(2), holds medicines for patients with specific needs that are very expensive or need specialist skill, prescribed through an authorisation system run by the benefit schemes. In May 2025 it registered Imcranib 100, a targeted cancer tablet made by the Chulabhorn Royal Academy's pharmaceutical plant.\n\nThe coordinates are the centroid of Mueang Nonthaburi district, not the street address. The Thai FDA publishes no average approval time for cancer medicines that OnCo could find.","asOf":"2026-11-04","links":[{"label":"Thai FDA: Collaboration on Streamlining Review for Pharmaceuticals, 11th Thailand-Japan Symposium (PDF)","url":"https://www.pmda.go.jp/files/000279149.pdf"},{"label":"National Drug Policy Division: NLEM sub-lists (Internet Archive, 8 September 2025, Thai)","url":"https://web.archive.org/web/20250908221706/https://ndp.fda.moph.go.th/drug/category/cat5"},{"label":"National Drug Policy Division: NLEM notices (Internet Archive, 10 July 2026, Thai)","url":"https://web.archive.org/web/20260710232928/https://ndp.fda.moph.go.th/drug/category/cat11"},{"label":"Food and Drug Administration, Thailand","url":"https://www.fda.moph.go.th"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":["imatinib"],"companies":[],"institutions":["hitap","nhso-thailand","nci-thailand"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-vargas-who-eml-cancer-chile-kenya-thailand-2026"],"journals":[],"dependsOn":[],"notes":[],"city":"Nonthaburi","country":"TH","lat":13.86,"lng":100.51,"institutionType":"government","website":"https://www.fda.moph.go.th","programs":["New drug registration: full (220 working days) and abridged reliance (154)","World Health Organization collaborative registration procedures (90 working days)","National List of Essential Medicines (National Drug Policy Division)","R2 restricted list for high-cost medicines"]},"route":"/institutions/thai-fda/","neighbours":{"drug":[{"id":"imatinib","kind":"drug","name":"Imatinib","route":"/drugs/imatinib/"}],"institution":[{"id":"hitap","kind":"institution","name":"Health Intervention and Technology Assessment Program (HITAP)","route":"/institutions/hitap/"},{"id":"nci-thailand","kind":"institution","name":"National Cancer Institute, Thailand","route":"/institutions/nci-thailand/"},{"id":"nhso-thailand","kind":"institution","name":"National Health Security Office, Thailand","route":"/institutions/nhso-thailand/"}],"paper":[{"id":"paper-vargas-who-eml-cancer-chile-kenya-thailand-2026","kind":"paper","name":"Best practices for implementing the WHO Model List of Essential Cancer Medicines: Chile, Kenya, and Thailand","route":"/key-papers/paper-vargas-who-eml-cancer-chile-kenya-thailand-2026/"}]}}