After years of close collaboration between the Thai Food and Drug Administration ("FDA"), the Pharmaceuticals and Medical Devices Agency of Japan (“PMDA”) and industry players, the Notification of Ministry of Public Health Re: Prescription of Pharmacopoeias No. 2, B.E. 2562 (2019) was finally published in the Royal Gazette on 26 July 2019, adding The Seventeenth Edition of The Japanese Pharmacopoeia (“JP”) and Supplements as the latest referenced pharmacopoeia for modern drugs. The Notification will become effective on 26 January 2020 (180 days after 26 July 2019).
According to the Drug Act, B.E. 2510 (1967) and its amendments, a drug product must be registered with, and obtain marketing authorization from, the FDA before it can be locally manufactured or imported for sale. The essential parts of the dossier to be submitted to the FDA for drug registration are the information on active pharmaceutical ingredients and finished drugs that must comply with the standards and analytical methods specified in the pharmacopoeia currently in force. If the in-house standards and analytical methods are used, justifications must be provided to support the equivalence.
With this latest notification, drug products from Japan with active pharmaceutical ingredients and finished drugs that comply with the standards and analytical methods in this JP or newer version as may be available in the future will now be accepted by the FDA for registration.
For more information about the requirements and preparation of a drug registration dossier, please contact us.