Regulatory Reforms
Tilleke & Gibbins / Thailand
Keen to learn more about regulatory reforms in Thailand? Read on! Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75.
1. Are there proposals for reform or significant change to the healthcare system?
The Patent Act
The Patent Act is currently under review and final revision by the Department of Intellectual Property, and is expected to be passed soon. The Act’s amendments aim to update Thai patent law according to international agreements and standards. Areas for amendment include:
- Reducing the long periods of pendency for patent registration and improving the patentability and enforceability of petty patents.
- Accepting the Protocol Amending the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) regarding Thailand’s public health.
- Facilitating Thailand’s accession to the Hague Agreement regarding design protection.
The Narcotics Act, 7th Amendment B.E. 2562 (2019)
The Narcotics Act was recently amended to allow:
- The use of medicinal cannabis and government controlled production of medicinal cannabis. Private Thai companies are now allowed to partner with certain government organizations to begin development and production of medicinal cannabis facilities. Private organizations will likely be licensed for commercializing medical marijuana independently, without government cooperation in 2024.
- Production of hemp for industry, so long as it contains less than 1% THC by dry weight and is produced in certain designated regions of Thailand.
- Ministerial regulations regarding the specific policies have not yet been published.
The Drug Act, 6th Amendment B.E.2562 (2019) and Notification of Thai FDA: Patent Declaration Form
According to the implementation of the Drug Act (6th Amendment) B.E. 2562 (2019), and Notification of Thai FDA: Patent Declaration Form, applicants who wish to register a modern drug are now required to submit a patent declaration form (Ror 1 Form)together with the drug registration application.
Herbal Product Act 2019
The Herbal Product Act 2019 was recently enacted, subordinate laws in relation to licensing, product registration/notification, official classification, etc., are currently under revision and/or public hearing. At present, if an individual or company aims to register a herbal medicine product, they must follow the current regulations published by the Division of Food or Drug.
2. When are they likely to come into force?
Implementation of Good Distribution Practice (GDP) for Drug Manufacturers and Drug Importers
In 2021, the Good Distribution Practice (GDP) will be officially implemented in Thailand. Thus, thus drug manufacturers and importers will soon be required to pass GDP inspections. Otherwise, their manufacturing import licenses cannot be renewed.
Full Implementation of the Risk Classifications According to the AMDD
In the future, the full implementation of risk classifications according to the AMDD will lead to the reclassification of medical devices in Thailand. The Thai FDA is currently drafting several notifications in order to facilitate the transitional period and prevent the shortage of medical devices in the country.
Implementation of a Complaint System for Medical Device
MPH Notification: Rules, Procedures and Conditions for Complaint Channels, Recorded Complaints and Management System of Complaints Relating to Medical Devices— Manufactured, Imported or Sold for Inspection by the Authorities was issued on November 5, 2020 and will be effective on May 4 , 2021. Once this Notification is implemented, medical device importers, manufacturers, and sellers will be required to implement a “complaint management system” and maintain records of complaints they receive. Records of complaints can be kept in hard copy format or as an electronic file in Thai or English language at the manufacturing place, importation place, or selling place. Complaints must be kept for at least 5 years from the manufacturing date.
Implementation of the Thai FDA Notification: Rules, Procedures and Conditions for Preparing Technical Documents to Confirm the Quality Standards, Efficiency, and Safety of Medical Devices upon the Inspection or Request of the Official B.E. 2563 (2020)
Medical device manufacturers and importers will be obliged to keep technical documents for all the registered medical devices at its manufacturing place or importation place. The documents can either be in a soft copy or hard copy format (in Thai or English). All of the documents must be available upon inspection or request by a Thai FDA official. This new requirement will be effective on June 13, 2021, for medical devices in Classes 1, 2 and 3 (low- to moderate-risk), and will become effective on September 11, 2021, for medical devices in Class 4 (high-risk).
Examples of required documents that must be kept at a manufacturing place or import place include:
- Documents that indicate the details of a medical device (e.g., generic name and trade name of medical device, GMDN code, name and address of manufacturer/ importer/ distributor, etc.)
- Executive summary
- Device description
- Device labeling
- Package insert (if applicable)
- Batch record/lot release
- Letter of Authorization for authorized representative
- Quality system certificate (if applicable)
Medical Device Defects or Adverse Effects Report (if applicable)
