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​ 

November 14, 2022
Following the delisting of cannabis grown in Thailand as a narcotic substance on June 9, 2022, many have explored the applications of cannabis in various fields, including medicine, healthcare, food products, cosmetics, and animal feed. For example, a poultry farm in northern Thailand conducted an experiment jointly with Chiang Mai University, mixing crushed cannabis into poultry feed and water. The experiment showed several benefits of this cannabis feed. Birds that were fed cannabis had lower mortality rates and achieved superior body mass, with increased levels of protein, fat, and moisture in the meat, leading to this method of organic bird farming yielding higher profits. Despite the results of this experiment, the mechanisms and action of cannabis in animal feed are still not yet fully understood, and there are concerns about the possible effects on human health of consuming cannabis-fed poultry. Until recently, cannabis regulations focused solely on the safety of use by humans, and there were no regulations on the use of cannabis in animals. However, on October 11, 2022, the Department of Livestock Development (DLD) published Notification Re: Guidelines on the Use of Hemp and Marijuana as Especially Controlled Animal Feed or Their Use as Ingredients in Especially Controlled Animal Feed in the Government Gazette. In general, the DLD notification requires that animal feed containing cannabis be shown to benefit the animals without causing concern for their safety. According to the Animal Feed Quality Control Act B.E. 2558 (2015), especially controlled animal feed must be registered before it can be manufactured domestically or imported into Thailand. The DLD notification lays down the following evaluation criteria for registration of animal feed containing cannabis: It is prohibited to use cannabis (both hemp and marijuana) apexes (i.e., leaf tips), inflorescence, or seeds—including extracts from apexes, inflorescence, or seeds—as especially controlled animal
Read More
October 14, 2022
Interest in organic farming, soil health, and regenerative agriculture has increased rapidly in recent years, and the demand for biological and organic fertilizers has accordingly undergone dramatic growth. Biological fertilizers contain specific levels of microorganisms (such as nitrogen-fixing bacteria); organic fertilizers similarly contain microorganisms and typically come from animals and plants, such as livestock manure and crop residues. Although responsible fertilizer use is still necessary to prevent unintended effects, these “living fertilizers” can boost yields and promote plant productivity without many of the adverse environmental effects and safety concerns of chemical fertilizers. This makes them highly sought after for organic farming, and prized by agricultural operators looking to promote soil health as a bedrock of sustainable agricultural practices. As the global trade for organic and biological fertilizers has scaled up, producers and agribusiness companies have expanded organic and biological fertilizer offerings to new markets. Not only do different countries have their own regulations for fertilizers in general, but they also often have specific requirements and rules for biological and organic fertilizers. This guide provides fertilizer producers and traders with an overview of the legal landscape for these fertilizers in three major Southeast Asian markets so that businesses can make their fertilizers available and foster sustainable agricultural practices in the region. The full Biological and Organic Fertilizers in Indonesia, Thailand, and Vietnam guide can be downloaded through the button below.
Read More
August 25, 2022
On July 27, 2022, Myanmar’s Ministry of Commerce (MOC) issued Newsletter No. 8/2022 to effectively ban foreign companies and foreign joint ventures from exporting value-added beans, corn, and sesame. This newsletter repealed Newsletter No. 2/2020, which had prescribed the criteria for beans, corn, and sesame to be considered “value-added” crops. These criteria had to be fulfilled in order for these commodities to be exported in accordance with Notification No. 24/2019, which had permitted foreign companies and foreign joint ventures to purchase seven categories of commodities from local manufacturers for export, subject to certain terms and conditions. These include: Meat and fish; Value-added crops; Pulp and paper; Seeds; Refined metals; Semi-finished or finished valued-added fruit products; and Timber-based furniture. With the repeal of the conditions in Newsletter No. 2/2020, foreign exporters are left with no reference criteria for how to achieve “value-added” status for beans, corn, and sesame, and thus will not be able to submit a complete application for the necessary export license. However, exportation of the other items in the list above remains unaffected and open to foreign exporters who meet the applicable requirements. The MOC explained their decision to revoke the permitted criteria by noting that some foreign companies were not actually producing beans, corn, and sesame that fulfilled the criteria for value-added status as laid out in Newsletter No. 2/2020, but were falsely exporting their goods as “value-added crops.” The revocation of the export criteria for beans, corn, and sesame took immediate effect. For more details on these export restrictions, or on any aspect of importation and exportation regulations in Myanmar, please contact Tilleke & Gibbins at [email protected].
Read More
August 23, 2022
On July 13, 2022, the Vietnamese government issued Decree No. 46/2022/ND-CP amending and supplementing some articles of Decree No. 13/2020/ND-CP providing detailed guidance on the Law on Animal Husbandry (“Decree 46”). The new decree took effect on the issuance date. Among the changes introduced by Decree 46 are a number related to animal feed. Recognition of Testing Methods of Exporting Countries Decree 46 clarifies the steps to recognize animal feed testing methods of laboratories in exporting countries. Under the amended regulations, the Department of Livestock Production (DLP) will organize an assessment team to appraise each dossier for recognition of animal feed testing methods within 30 days of receipt of a complete dossier. If the dossier lacks required information or authenticity, the DLP will organize a practical assessment team at the exporting country’s testing laboratory. If the dossier passes the assessment, within five working days from the completion of the assessment, the DLP will issue a decision on recognition of the testing method. The validity of this decision has been lengthened from three years to five years. State Inspection of Animal Feed Quality Process of State Inspection Decree 46 specifies the process to conduct state inspection of the quality of imported animal feed by unifying the regulations stipulated in the related legal documents listed in Decree 13. The process includes the submission of a state inspection dossier, timelines to receive feedback from the inspection authority, and further steps that can be taken upon receiving acceptance or refusal decisions from the authority. For traditional animal feed and complete compound animal feed, imported shipments are customs-cleared as soon as the importer completes the customs procedures. Within 15 days from the customs clearance date, the importer must submit the conformity assessment results. The importer has complete responsibility for the conformity assessment results, and
Read More