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​ 

May 10, 2023
Cambodia’s Ministry of Health (MOH) has issued a notification reminding advertisers of health products and cosmetics in the country to obtain the required advertising approvals from the MOH. Issued on April 21, 2023, MOH Notification Letter No. 2198 on the Unauthorized Advertising of Modern Medicines, Traditional Medicines, Health Supplements, Medical Devices, and Health Supporting Products confirms that the MOH is aware of unauthorized advertising taking place in Cambodia, and signals its intention to increase enforcement efforts. It is therefore important for advertisers not yet in possession of the necessary approval to obtain the required advertising authorizations before marketing their health products in Cambodia. Advertising Framework for Health Products in Cambodia To legally advertise a health product in Cambodia, it must first be registered with the MOH (except for cosmetics, which only require notification). Only then can advertising approval be sought from the MOH, which will review the content of the proposed advertisement for compliance with Cambodian law. Approval is subject to a time limit, depending on the manner of advertising. All forms of advertising are covered under the MOH’s purview, including online, offline, business-to-consumer (B2C), business-to-business (B2B), promotion to healthcare professionals, and any other form of advertising. Key regulations prescribing general advertising rules are the Law on Consumer Protection, the Law on E-commerce, and the Sub-Decree on the Management of Commercial Advertising of Products and Services. However, product-specific regulations may also apply, depending on the type of product. For example, certain products may be subject to the regulation that sets rules for trading cosmetics in Cambodia, the (amended) Law on the Management of Pharmaceuticals, or others. Usually, product-specific regulations apply first, with the general product advertising rules being applied in addition wherever they do not conflict with the product-specific regulations. A key issue found among both general and product-specific
Read More
May 3, 2023
Attorneys from Tilleke & Gibbins have contributed the Laos and Thailand chapters to the newly released CMS Expert Guide to Cannabis Law and Legislation. The Thailand chapter was provided by Alan Adcock, partner and head of the firm’s regional life sciences team, while Dino Santaniello, head of Tilleke & Gibbins’ office in Laos, produced the Laos chapter. The guide provides an overview of the legal framework regulating cannabis in 33 jurisdictions around the world. It covers topics such as medical, recreational, and industrial use of cannabis, as well as the patentability of cannabis-based products. The guide’s chapters offer high-level information on the legal approach taken in each jurisdiction, as well as guidance for companies and business activities exploring possibilities in relation to cannabis and hemp. The Laos and Thailand chapters—as well as the full guide to cannabis law in 33 jurisdictions—are available on the CMS website.
Read More
April 20, 2023
Food safety is one important area of focus as Cambodia continues to improve its regulatory framework surrounding consumer protection. Last year, the new Law on Food Safety set out the main principles to regulate the food sector, providing general rights and obligations of food businesses and requirements for food products traded in Cambodia. Then in the first months of 2023, two implementing regulations were issued to clarify the overarching principles of the Law on Food Safety, as well as its enforcement mechanisms. The adoption of these enforcement-related regulations is once again a clear signal to the market that the Cambodian government is taking the enforcement of consumer protection laws seriously. Food Surveillance, Seizure, and Recalls The first of these implementing regulations was Sub-Decree No. 13 on the Conditions, Formalities and Procedures for Food Surveillance and Seizure, dated January 6, 2023 (SD 13), followed the next month by Prakas No. 080 on the Forms and Procedures to Seize Unsafe Foods or Foods Not Complying with Technical Regulations, dated February 22, 2023 (Prakas 80). These implementing regulations give clarity on how the authorities will monitor and inspect the food sector, and in what cases the authorities may resort to recalls or seizure of foods. Prakas 80 also provides the necessary paperwork for both inspecting officers and companies to use when reporting on unsafe foods to authorities and the public. Lastly, the regulations further clarify the obligations for food businesses and the penalties for noncompliance. The Consumer Protection, Competition, and Fraud Repression Directorate-General (CCF) of the Ministry of Commerce takes a key role as the main enforcement authority under the regulations. The CCF receives reports on unsafe foods, manages voluntary recalls, publishes warnings to the public regarding unsafe foods, seizes unsafe or otherwise noncompliant goods, and applies the administrative fines and penalties
Read More
March 24, 2023
Attorneys in Tilleke & Gibbins’ Jakarta office have contributed a new “Life Sciences Regulation in Indonesia” chapter to Practical Law’s updated Life Sciences Global Guide. The chapter covers a range of regulatory issues related to the development, manufacturing, and selling of pharmaceutical products and medical devices, including the following topics: Pharmaceuticals: Laws and regulatory authorities Clinical trials: Legal, regulatory, and procedural requirements Manufacturing and distribution Marketing: Authorization for marketing medicinal products, monitoring compliance and penalties, pharmacovigilance and other commitments, foreign marketing authorizations Data privacy Packaging, labeling, and tracking Biological medicines Medical devices: Legislation and regulatory authorities, definition and classification Healthcare IT Combination products and borderlines Natural health products Developments, reforms, and proposals Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Regulation in Indonesia” chapter can be accessed on the Practical Law website
Read More