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Thai FDA New Drugs Regulatory Services in Thailand
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Drug Approval & Regulatory Support In Thailand
- Thailand’s Pharmaceutical market was estimated $6.4 billion in 2021
- Thailand is Asia’s 2nd biggest pharmaceutical market after Indonesia
- The Thai Government plans to implement various initiatives through 2016 to 2025 to make Thailand a “Hub of Wellness and Medical Services”
Artixio’s regional presence in Thailand and experience with pharmaceutical products compliance in the country has helped our clients access the market to register and introduce their pharmaceutical products in Thailand. We can support through entire product lifecycle using regulatory advisory and operational services for new molecules, generic drugs, biologics and biosimilars.
Thai FDA Drug Approval & Licensing Process
Ministry of Public Health
Food & Drug Administration
Bureau of Drugs
- System Development Division
- Pre-Marketing Division
- Standards & Regulations Division
- Post-Marketing Division
Pre-Marketing Division
- Pharmaceutical Products Division
- Advertising Control Sub-Division
- IND Sub Division
- Biological Product Sub Division
- Herbal & Traditional Medicine Sub Division
- Veterinary Medicine Sub Division
- New Strength (NS)
Regulatory Authority for Pharmaceuticals in Thailand
The pharmaceutical products are regulated by Bureau of Drugs under Food and Drug Administration Secretariat. The main role of the Thai FDA is to protect consumers health, especially, to ensure safety, quality and efficacy of health products within its remit. These include foods, drugs, psychotropic substances, narcotics, medical devices, volatile substances, cosmetics and hazardous substances available in the country. This has to be implemented in accordance with national legislation and international agreements.
New Drugs Regulations in Thailand
The current laws and regulations in Thailand for drugs are:
- Drug Act B.E. 2510 (1967)
- Drug Act (3rd Revision) B.E. 2522 (1979)
- Drug Act (4th Revision) B.E. 2527 (1984)
- Drug Act (5th Revision) B.E. 2530 (1987)
- Ministerial Regulation on Drug Registration B.E. 2555 (2012)
Definition of New Drugs
- New Chemical Entities (NCE)
- New Indication (NI)
- New Combination (NCO)
- New Delivery System (ND)
- New Route of Administration (NR)
- New Dosage Form (NDOS)
- New Strength (NS)
Definition of Generic Drugs
- Same active ingredient(s)
- Same dosage form
- Same strength
- Same route of administration
- Same conditions of use
Compared to reference drugs (New Drugs in Thailand which registered after 1991)
Drug Registration Process in Thailand
There are two main steps in registration of pharmaceutical products in Thailand
I. The permission to import/manufacture drug samples
Documents Required:
- Application form (Por Yor 8/Nor Yor 8/Yor Bor 8)*
- Manufacturer/Importer Name and Address
- License to manufacture/import Number
- Product Name and Description
- Drug Formula (active ingredient(s) only)
- Packaging
- Quantity of drug sample to manufacture/import
- Labels
- Leaflets
- Part 1: Administrative Data and Product Information
- Part 2: Quality Document
- Part 3: Nonclinical Document
- Part 4: Clinical Document
Artixio's Services in Thailand
Regulatory Strategy & Intelligence
Artixio’s regional regulatory experts provide insights into Thailand regulations for pharmaceutical and biologic products right from development to authorization. Depending on the stage you are in of your journey, our team can provide you evidence based strategic insights to make suitable decision for successful product registration in Thailand. Our services include,
- Insights on Thailand’s Regulations for New Molecules, Generics, Biologics, Biosimilars and Combination products
- Consultation on Regulatory Pathway for your product and therapeutic indication
- GMP and audit requirements based on your existing approvals in other countries
- Insights on pricing, market opportunity, distribution channels and cost of landing the product
- Thai FDA consultation strategy
Regulatory Affairs
Our experience with Thai FDA and regional experts support our clients with end to end registration of pharmaceutical and biologic products in Thailand. Our services include,
- Dossier gap analysis based on existing approvals in reference markets (USA, EU, Australia etc.)
- Dossier preparation for Thai FDA submission
- Consultation meeting with Thai FDA
- Response to queries
- Obtaining license post approval
Market Access
Market Access
Enabling patients’ access to therapies requires authorization from health authorities and payers’ acceptance of pricing based on therapy’s benefits and advantages over existing options. The pricing is driven by insights from key opinion leaders, prescribers’ understanding of the therapy, payers’ policies and regulatory framework on certain disease areas in the country.
The key benefits and advantages over existing treatments are part of drug development planning and therefore, it can be stated that Market Access is a key consideration right from the early stage of drug development.
Artixio’s team brings wealth of experience across complex therapeutic areas and global markets to help you address key questions for your market access strategy –
Pricing:
- Targeting expected indication and therapy
- Existing therapeutic modalities and line of therapy
- KOL opinion on new therapy’s advantages and benefits over current options
- Price comparator with existing therapies under applicable treatment setups to assess ‘effective cost of treatment’ through the lifecycle of treatment
- Risks based on side effects
- Scientific data supporting product’s advantages
- Reimbursement:
- Reimbursement policies in the country
- Timeline and process for reimbursement approvals
- Identification of primary markets for product launch based on reimbursement scenario
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