4 June, 2019
On April 16, 2019, the Drug Act (No. 6) B.E. 2562 was published in the Government Gazette, amending the previous drug registration processes, clinical research processes, and fee schedules. The changes will apply to all pending applications and those filed from October 13, 2019 onward.
New Requirements for Registration
An additional requirement has been added to the registration process for new drugs. Along with the drug registration dossier, the following documents must now be submitted for each drug classification:
- For modern drugs—documents that show the publication numbers of published patent or petty patent applications.
- For traditional drugs—documents that show the registration of right concerning Thai traditional medicine in accordance with the Protection and Promotion of Traditional Thai Medicine Knowledge Act B.E. 2542 (1999).
Validity of Certificates of Registration
Whereas drug formula registration certificates did not expire under the previous law, under the amended Act they must be renewed every seven years. After a certificate expires, the holder has a one-month grace period to file a renewal application, provided the late application is deemed “reasonable,” and subject to a fine of one-half the rate of the respective type of license plus THB 500 for each day past the certificate’s expiry.
- The Thai Food and Drug Administration (FDA) has defined the validity of existing drug formula registration certificates as follows:
- certificates issued prior to September 11, 2019, as follows:
- certificates registered before January 1, 1997, will expire October 13, 2024;
- certificates registered from January 1, 1997, to December 31, 2007, will expire October 13, 2026; and,
- certificates registered from January 1, 2008, up to October 13, 2019, will expire October 13, 2028.
Optimized Drug Registration Administration
Also incorporated into the Act is Order No.77/2559 of the Head of the National Council for Peace and Order, concerning the efficiency of registering health products. The main provisions of that order are as follows:
- The FDA’s product approval timeline must not exceed the time specified in its public manuals.
- The FDA will consider the official fee schedule (as announced by the Minister of Public Health from time to time) in its approval process. Further, unlike in the past, official fees earned by the FDA will not be refunded to the Ministry of Finance as government revenue, but will instead be used to improve the approval procedure.
- The FDA will outsource some work, such as onsite inspections and evaluations of technical documents, to external experts of local or overseas agencies, who have been approved by, and registered with, the FDA.
Guidelines for Clinical Research Compliance
A new section was added on the procedure, regulations, and conditions of drug research and the penalties for noncompliance.
- The Minster of Public Health now has the power to set and change procedures, regulations, and conditions for drug research by announcing them in the Government Gazette.
- The secretary-general of the FDA can temporarily suspend, completely stop, or order an improvement of a drug research study not complying with the minister’s published guidelines.
- Violating an order of the secretary-general of the FDA is subject to a fine of up to THB 100,000.
For further information, please contact:
Atthachai Homhuan, Manager, Regulatory Affairs, Tilleke & Gibbins
atthachai.h@tilleke.com
