Thai FDA New Drugs Regulatory Services in Thailand

Services We Offer

Drug Approval & Regulatory Support In Thailand

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

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

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

*Por Yor 8 = Manufacturer drug product Nor Yor 8 = Importer drug product Yor Bor 8 = Manufacturer Thai Traditional drug II. Application for product registration approval Documents Required: ASEAN Common Technical Dossier (ACTD)

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