You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

September 20, 2023

Thailand Prepares to Renew Drug Marketing Authorizations as First Expiration Nears

Subscribe to Updates

Thailand is preparing to open its first renewal period for drug marketing authorizations (MAs) since the passage of the Drug Act (No. 6) B.E. 2562 (2019).

Before 2019, MAs for pharmaceuticals and vaccines in Thailand had lifelong validity. The 2019 Drug Act stipulated that all new MAs would be valid for seven years and could be renewed.

The 2019 law also set out expiration dates for existing pharmaceutical products registered and approved prior to the implementation of the law (i.e., before October 13, 2019):

  • Drug MAs issued before January 1, 1997, expire on October 13, 2024.
  • Drug MAs approved between January 1, 1997, and December 31, 2007, expire on October 13, 2026.
  • Drug MAs approved between January 1, 2008, and October 13, 2019, expire on October 13, 2028.

Based on these dates, the first renewal period for drug MAs will commence in the fourth quarter of 2023. To facilitate the renewal process, the Thai Food and Drug Administration (FDA) has publicized draft regulations and notifications on the required application form and documents, the rules and conditions, and the process for renewing an MA.

In May 2023, the Thai FDA issued Ministerial Regulation Re: Renewal of Drug MA Licenses B.E. 2566 (2023) to prescribe the essential requirements for filing a renewal application:

  • To renew a drug MA, holders must submit their renewal application to the Thai FDA within the one-year period before the MA’s expiration date.
  • Renewal applications can only be submitted online via the Thai FDA’s electronic system.
  • The Thai FDA will grant approval for an MA renewal if the following conditions are satisfied:
    • The documents in relation to efficacy and safety are up-to-date, accurate, and in accordance with academic principles.
    • The specification and analytical method comply with the official pharmacopeias as prescribed in the Drug Act, as amended. For noncompendial specifications or methods, justification or evidence that substantiates the quality, safety, and efficacy of the drug product must also be provided.

The ministerial regulation also provided examples of required information and documents:

  • Evidence of the quality, efficacy, and safety of the drug products.
  • Label and package insert.
  • Documents demonstrating the patent number or petty patent number as announced in Thailand.
  • GMP (Good Manufacturing Practice) clearance letter (for imported drug products).

It is expected that the official document checklist and other requirements will be published in the fourth quarter of 2023. MA holders should recheck the renewal period for their pharmaceutical products and start preparing the most up-to-date version of the drug registration dossier.

Those who obtained conditional approval for COVID-19 drugs and wish to continue their related business operations must apply for a new conditional approval under Thailand’s new rules for conditional approval before the expiration of their current MA.

For more details on drug MA renewal, please contact Kittiya Nopparatrungroj at [email protected] or +66 2056 5750.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

February 9, 2023
Vietnam’s Ministry of Finance is drafting a circular on determining the origin of imported and exported goods. This circular, a draft version of which has been released for public comment (“Draft Circular”), consolidates prevailing regulations and guidelines on determining the origin of imported and exported goods that are stipulated in the following legal documents, which the Draft Circular would replace when it comes into effect: Circular No. 38/2018/TT-BTC dated April 20, 2018, of the Ministry of Finance regulating the determination of origin of imported and exported goods, as amended by Circular No. 62/2019/TT-BTC dated September 5, 2019, of the Ministry of Finance; Circular No. 47/2020/TT-BTC dated May 27, 2020, regulating the time to submit documents proving the origin of goods and form of the documents proving the origin of imported goods applied during the Covid-19 pandemic; and Circular No. 07/2021/TT-BTC dated January 25, 2021, regulating the time to submit documents proving the origin of imported goods under the EU-Vietnam Free Trade Agreement (EVFTA). Generally speaking, the Draft Circular does not increase the administrative procedures for importers and exporters, but rather seeks to codify the recent practices implemented by the customs authorities. The Draft Circular focuses on providing comprehensive guidance for importing/exporting companies when carrying out administrative procedures to certify the origins of imported and exported goods to be in line with current trade practices and international commitments under new-generation free trade agreements. In particular, the Draft Circular supplements guidelines on declaring origins and submitting Certificates of Origin (C/Os) of imported goods under the EVFTA and the Regional Comprehensive Economic Partnership Agreement (RCEP). The Draft Circular also provides some new guidelines to facilitate exports (and imports) and overcome some obstacles and issues when implementing the prevailing regulations. For example, the submission of C/Os online, which was only applicable during the
Read More
January 27, 2023
The opening weeks of 2023 have already seen a sharp increase in enforcement against violations of product labeling and advertising rules in Cambodia, in line with a notice issued by the country’s Directorate-General for Consumer Protection, Competition, and Fraud Repression (CCF) last year. Since the Law on Consumer Protection was adopted in 2019, a major legislative push has been seen, with general rules coming out focusing on providing consumers with sufficient information on products and services, for example via product labeling or advertising rules. Then, more detailed regulations were adopted for specific product categories, for example for food products and cosmetics. Khmer language requirements have been a key feature of the recently adopted rules on advertising and labeling. Despite the Khmer language mandates in consumer protection laws and regulations, enforcement and compliance was low. Most products on the market—especially imports—did not comply with the language requirement. In line with the revamped regulatory framework, the CCF has increased its enforcement, enabled by recent substantial budget increases. They have adopted clear implementing regulations for their officers to enforce in a practical yet effective manner, and they have been issuing notices reminding companies to comply with the new rules. A September 2022 notice announced that increased CCF enforcement of product labeling rules would start on January 1, 2023. As noted above, this has already proven to be true, and enforcement is now proceeding in earnest. Companies should take heed of this notice and ensure compliance with the Khmer language requirements (detailed below), as the CCF has shown that it readily acts against violators, from small retailers to large conglomerates. Khmer Language Requirement A sub-decree issued November 4, 2022 requires all commercial advertising of products and services—by any channel—to use Khmer as the primary language. If foreign-language text is used in advertisements, it
Read More
January 10, 2023
On January 9, 2023, Vietnam’s National Assembly voted to approve a draft resolution on the continued implementation of policies for the prevention and control of the Covid-19 pandemic. Under this resolution, marketing authorizations (MAs) for the following drugs and medicinal ingredients will be extended to December 31, 2024, allowing continued use in Vietnam: Drugs and medicinal ingredients whose MAs expire from January 1, 2023, to December 12, 2024, and whose extension dossiers have been submitted but have not yet been approved in accordance with the Law on Pharmacy; and Drugs and medicinal ingredients whose MAs have been extended as per Resolution No. 12/2021/UBTVQH15 and have not been extended in accordance with the Law on Pharmacy. The extension does not apply to the following cases: Drugs and medicinal ingredients that have been recalled by the Law on Pharmacy; Drugs with signs of being unsafe for users that have been suspended from circulation/use and sealed for preservation in accordance with the Law on Pharmacy; and Drugs with MAs having a validity term of three years in accordance with the Law on Pharmacy. The Ministry of Health will announce the list of drugs and medicinal ingredients whose MAs are subject to be extended as described above.
Read More
November 23, 2022
The delisting of cannabis as a controlled narcotic in Thailand on June 9, 2022, was a breakthrough moment for the industry.  Not only are farmers and others in the industry elated that such a step was taken, it has triggered the establishment of an abundance of cannabis dispensaries in Bangkok and other popular domestic and international tourist destinations in Thailand, including Chiang Mai, Pattaya, Phuket, and many islands. Vulnerable populations, such as children, accessing cannabis has also become a hot-button issue. Thailand’s Ministry of Public Health (MOPH) was initially criticized by some for its policy of allowing cannabis to be sold with few restrictions. On June 17, 2022, the MOPH followed up with the Announcement Re: Controlled Herbs (Cannabis) under the Thai Traditional Medical Knowledge Act, which seemed to implement a viable mechanism to regulate cannabis dispensaries. This announcement contained prohibitions on selling cannabis to vulnerable populations (minors, expectant women, and breastfeeding mothers) and on smoking cannabis in public. Furthermore, the draft Cannabis and Hemp Act includes provisions related to sales and distribution channels and advertisements for particular dispensaries. However, the draft act has been delayed due to disagreements among some political parties during the reading of the legislation, and is unlikely to be implemented in 2022 as had been widely expected.  The tug-of-war among the political parties has caused concerns about whether the country’s recent liberalized cannabis policy will be revisited and cannabis relisted as a narcotic. With this uncertainty over when the draft Cannabis and Hemp Act will be implemented, the MOPH has focused on identifying gaps in current regulation that might allow the misuse of cannabis. The minister of the MOPH has announced that the MOPH announcement of June 17, 2022, will be repealed and replaced by the November 11, 2022, Announcement Re: Controlled Herbs (Cannabis).
Read More