Thailand’s pharmaceutical sector is expanding rapidly, fueled by a growing healthcare market and an evolving regulatory environment that aims to balance safety, innovation, and accessibility. For companies seeking to enter the Thai pharmaceutical market, understanding the regulatory framework is crucial – particularly the drug classification system and product registration process administered by the Thai Food and Drug Administration (Thai FDA).
Classification of Drugs in Thailand
Thailand classifies pharmaceutical products into two primary categories: new drugs and generic drugs. This distinction not only determines the complexity and duration of the regulatory review process but also impacts the supporting documents required for registration.
New Drugs
“New drugs” in Thailand refer to pharmaceutical products containing active substances that have not previously been approved for medical use in the country. Due to the novelty and lack of prior local regulatory experience with these products, the Thai FDA imposes stringent requirements to assess their safety, efficacy, and quality.
Subcategories of new drugs include:
- New Chemical Entities (NCE)
- New Indications (NI)
- New Combinations (NCO)
- New Delivery Systems (ND)
- New Routes of Administration (NR)
- New Dosage Forms (NDOS)
- New Strengths (NS)
Registration of new drugs typically involves a detailed technical dossier, including clinical and non-clinical study results, and may require pre-submission consultations with the Medicines Regulation Division of the Thai FDA.
Generic Drugs
Generic drugs are pharmaceutical products that contain the same active ingredients as their reference brand-name counterparts. They are equivalent in dosage form, strength, route of administration, and intended use. Although they do not undergo the same rigorous clinical evaluations as new drugs, generic products must still meet strict standards for quality, safety, and bioequivalence.
Common attributes of generic drugs include:
- Identical active ingredient(s)
- Same dosage form and strength
- Same route of administration
- Same therapeutic use
The streamlined registration process for generics encourages wider accessibility and affordability of essential medicines in the Thai market.
Regulatory Oversight and Requirements
Thailand’s Drug Act B.E. 2510 (1967) and its subsequent amendments form the foundation of pharmaceutical regulation. Any pharmaceutical product, whether manufactured domestically, imported, or ordered into Thailand, must comply with this law.
Finished Pharmaceutical Products
Any finished product intended for human or animal use must be registered with the Thai FDA before it can be manufactured, imported, or distributed in Thailand. Once registration is granted, further steps may still be required, particularly for specialized products such as vaccines or controlled substances.
Additional Requirements for Certain Products
- Lot Release Certification:
Human vaccines and plasma-derived products must obtain a Certificate of Lot Release from the Institute of Biological Products, Department of Medical Sciences before being released for use.
- Approval for Controlled Drugs:
Certain finished pharmaceutical products and drug substances listed under the Ministry of Commerce’s Notification (e.g., beta-agonists) must receive additional approval from the Thai FDA before import permits can be issued.
Active Pharmaceutical Ingredients (APIs)
APIs, raw materials containing active substances, must be notified to the Thai FDA prior to importation, manufacture, or ordering into the country. These substances are categorized as “pharmaceutical chemicals,” and their manufacturers must comply with internationally recognized quality standards such as Good Manufacturing Practice (GMP).
Key requirements for APIs include:
- Notification to the FDA as pharmaceutical chemicals
- Proof of compliance with GMP standards for manufacturing facilities
- Payment of notification fees
Drug Registration Process and Documentation
The process for registering pharmaceutical products in Thailand depends on the type and intended use of the product. Whether registering a finished product or notifying an API, applicants must prepare and submit comprehensive documentation in line with established international standards.
ASEAN Common Technical Dossier (ACTD) and ICH CTD
Drug registration dossiers must follow one of two recognized formats:
- ASEAN Common Technical Dossier (ACTD)
- International Council for Harmonisation’s Common Technical Document (ICH CTD)
These dossiers include detailed information across four key modules:
- Administrative and Product Information
- Quality Documents
- Non-clinical Studies
- Clinical Studies
Applicants may consult the Thai FDA’s Medicines Regulation Division for guidance before dossier submission. Registration fees apply and vary depending on the type of product.
Registration of Products for General Sale
After obtaining a license to operate a drug facility (for manufacturing or importing), companies must:
- Submit a complete ACTD or CTD to the Thai FDA
- Obtain regulatory approval for each product before importation or manufacture
- Secure additional certificates (if required) for certain types of products (e.g., vaccines)
Special-Use Pharmaceutical Products
Thailand also permits the manufacture or importation of drugs for specific non-commercial purposes. These include:
- Drug Samples for Registration
Companies can import small quantities of pharmaceutical products as reference samples for dossier preparation and testing. - Clinical Trials
Drugs intended for human clinical trials must follow procedures under Section 79 bis of the Drug Act, including separate applications for trial authorization. - Analytical Testing
Laboratories or institutions may import drugs for analytical research without intent to market or sell them. - Donations to Healthcare Facilities
Drugs donated by humanitarian organizations or pharmaceutical companies must comply with specific procedures to ensure their safety and quality. - Exhibitions and Trade Shows
Products imported for display purposes only (e.g., in medical exhibitions) may be exempt from standard distribution requirements but still require prior notification.
Recent Regulatory Update: Streamlined GMP Approval Process
In June 2024, Thailand’s FDA released a draft bill to streamline GMP approval for imported drugs. The bill, now under review by the Ministry of Public Health, aims to simplify requirements and speed up the registration process.
Under the proposal, importers sourcing drugs from foreign facilities that are part of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) or ASEAN-listed inspection services will no longer need to submit traditional GMP certificates or CPPs. Instead, alternative documents proving GMP compliance will be accepted.
For manufacturers outside these recognized systems, a new risk-based approach will apply. Higher-risk facilities will face stricter scrutiny and must submit more extensive documentation. The Thai FDA also plans to accept a wider range of GMP evidence, instead of just official certificates.
If enacted, the bill would reduce regulatory burdens for trusted manufacturers while maintaining oversight for higher-risk sources, ultimately accelerating access to Thailand’s drug market.
Conclusion
Pharmaceutical registration in Thailand is a structured but nuanced process governed by the Thai FDA under the country’s Drug Act. Understanding the distinction between new and generic drugs is the starting point for regulatory planning. From dossier preparation and GMP compliance to post-approval requirements and importation procedures, companies must navigate multiple layers of review and approval.
By preparing thoroughly, engaging proactively with regulators, and adhering to both local and international standards, pharmaceutical companies can successfully access Thailand’s dynamic and growing market.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.