2024 Thailand Pharmaceutical Regulatory Update

In recent years, Thailand, a Southeast Asian country with 70 million people, has been consistent in its commitment to improving the regulation of pharmaceuticals, ensuring the safety, efficacy, and accessibility of drugs in the market. Two significant developments include the initiation of the initial review period for drug market authorizations (MAs) and the introduction of new regulations governing drugs imported for clinical trials.

Renewal of Drug Market Authorizations

The implementation of the 2019 Thai Drug Act led to a fundamental shift in the regulation of drug market authorizations (MAs) in Thailand. Unlike the previous system, where MAs had indefinite validity, the new regulations introduced a seven-year validity period, making renewals a requirement to continue marketing drugs in Thailand. As the first batch of MAs approached expiration in late 2023, the Thai FDA outlined a detailed schedule for renewal, with the initial review period set to begin in the fourth quarter of 2023.

To facilitate a smooth renewal process, drug manufacturers are required to submit renewal applications at least a year before the MA expires. These applications must adhere to the latest drug registration requirements and include documentation verifying the continued safety and efficacy of the drug. In addition, drug applicants are encouraged to utilize the Thai electronic filing system to streamline the renewal process. The meticulous approach taken by the Thai FDA underscores the government’s commitment to upholding stringent standards in pharmaceutical regulation and ensuring the well-being of the public.

Regulations for Drugs Imported for Clinical Trials

The introduction of new regulations governing drugs imported for clinical trials represents a significant milestone in Thailand’s clinical research landscape. Prior to these regulations, there were no specific requirements governing Clinical Trial Applications (CTAs). However, under the new rules, drug sponsors must submit a CTA to the Thai FDA for approval before initiating any clinical trial in the country.

One of the key features of the new regulations is the emphasis on enhanced oversight and post-approval obligations. The Thai FDA now has the authority to actively inspect and oversee clinical studies at various stages and to cancel studies if they deem it necessary. Furthermore, detailed reporting requirements such as the submission of progress reports and adverse event reports have been established to ensure transparency and compliance with international standards.