The Drug Act for Enhancing Efficiency of Drug Approval Process and Protection for Consumers, the amendment to the Drug Act (No. 6) 2019 was officially published in the notification in the Government Gazette on April 16th 2019 and would come into force with effect from October 13th 2019.
The amendment to Drug Act allow experts with essential qualifications to enroll with the Food and Drug Administration Thailand viz. FDA to evaluate documents, analyze the product as well as audit business premises for FDA. Executive regulations on the criterion and conditions for enrollment of experts would be subsequently announced under the Drug Act.
The Drug Act maintains the requirement for an applicant for drug registration to forward the documents with information regarding relevant patents/petty patent and the validity period of a drug license. For traditional drugs the documents must represent the registration of right related to Thai traditional medicine as per Protection and Promotion of Traditional Thai Medicine Knowledge Act, 1999. Drug registered licenses that were issued before the Drug Act came into effect shall remain valid for five to nine years. However, the validity period of drug registration licenses granted after implementation of the Drug Act has been extended to seven years from the date of issue as laid down in the bill.
The Minster of Public Health has been given the power to set and change conditions, regulations, procedure with respect to drug research by publishing in the Government Gazette. Also, the penalty for violation of an order of the Secretary-General FDA is subject to a fine of up to THB 100,000.
These amendments are an attempt to make the drug industry robust and competitive besides balancing the public welfare aspect.
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