The Food and Drug Administration (FDA) is committed to elevating the pharmaceutical manufacturing standards in public hospitals to support the government’s policy of developing Thailand as the Medical Hub, by adopting international pharmaceutical manufacturing standards. This initiative aims to ensure that patients receive high-quality, effective, and safe medicines in accordance with international standards.

   Dr. Withid Sariddeechaikool, Deputy Secretary-General of the FDA, stated that the FDA, as the regulatory body overseeing the manufacturing and distribution of pharmaceuticals in the country, has been working to upgrade the pharmaceutical production standards in hospitals that provide services to patients. The goal is to align the production standards in these hospitals with those of the pharmaceutical industry, which will help enhance confidence in Thailand’s pharmaceutical system and contribute to the growth of the health industry.

   Starting from 1st November 2024, the production of medicines in situ by public hospitals for their patients —except for medicines produced for specific individual patients or those made according to a doctor's prescription—must comply with the “PIC/S Guide to Good Practices for The Preparation of Medicinal Products in Healthcare Establishments”, which is an internationally recognized standard for pharmaceutical manufacturing. Furthermore, for the production of advanced therapy medicinal products (ATMPs), such as gene therapy medicinal products, hospitals must also comply with the regulations set forth by the Ministry of Public Health on the production guidelines, methods, and conditions for manufacturing modern medicines. This will guarantee that medicines produced in hospitals meet quality, efficacy, and safety standards.

   The FDA emphasizes that medicines produced for patients in hospitals are prepared by medical professionals in strict adherence to professional standards. Patients can therefore be confident in the quality and safety of the medicines they receive. In the future, upgrading pharmaceutical production standards will enable all public hospitals to produce medicines that meet international standards, ensuring that patients receive the highest quality and safest medicines.

   For more information, please refer to the Ministry of Public Health Notification of 2024 regarding Pharmaceutical Production Practices in Hospitals which is available at https://drug.fda.moph.go.th/public-relations-new/31102024.

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News Publication Date: 15 November 2024