top of page
Image by Mos Sukjaroenkraisri

Pharmaceuticals Registration 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.

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.

tfda.png

Drug 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:

  1. 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

  2. Labels

  3. 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

 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  

Regulatory Operations

Our regulatory operations services support pre and post registration of pharmaceutical products.

  • Publishing and submission in required format

  • Notarization where applicable

  • Translation in Local Language

  • Regulatory Information Management

  • Post Approval Maintenance such as license renewals, annual reports

Labeling & Artwork

Our end to to end labeling and artwork services support compliance driven labeling content authoring, graphic design and printing for pharmaceutical products. With teams experienced in managing clinical and commercial labeling for diverse products, Artixio provides high quality services to supporting our clients' labeling and artwork requirements.  

  • Target Product Profile 

  • Core Data Sheet Authoring and Management 

  • Core Safety Information Authoring 

  • Literature Search and Review 

  • Medical Writing 

  • Labeling Operations Management 

  • International Labeling 

  • SmPC, PIL Support 

  • Artwork Proof Reading (SmPC, PIL, Blister Packs, Cartons etc.)

  • Graphic Design 

  • Artwork Change Management 

  • Artwork Process Coordination 

  • Labeling and Artwork Project Management

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 in reimbursement scenario

Market Intelligence

Artixio enables data driven executive decisions across C-Level, marketing, R&D, clinical, regulatory and commercial department right from product development, product launch and post marketing support. Our team has decades of experience and insights to global markets in planning and commercializing pharmaceutical, med-tech, cosmetic and nutrition products.

 

Our comprehensive market intelligence approach covers all key areas of life-sciences products to enable critical commercial decisions for,

  • Develop key product differentiators and product development plan

  • Competitor analysis (business, Intellectual Property, clinical, product claims/benefits etc) and developing counter competitive strategies

  • Market landscape analysis to

    • quantify market opportunity and market size

    • identify key sales and distribution channels (pharmacy and retail sales, hospital sales, salons/spas, online ecommerce and others)

    • Develop country specific product launch strategy – product portfolio selection, pricing, sales/distribution channels, marketing messages, marketing collateral requirements, regional Key Opinion Leaders, consortiums and events

  • Assess target market and key market positioning

  • Develop key marketing strategy and marketing messages

  • Pricing benchmarking for product positioning and value proposition

  • Disease Area Strategy based on therapeutic area landscape analysis, therapeutic modalities and cost of treatment

  • Clinical Intelligence to assess competitors’ product development and clinical strategy to develop a differentiated clinical development roadmap

Branding & Product Launch

Our end to to end labeling and artwork services support compliance driven labeling content authoring, graphic design and printing for pharmaceutical products. With teams experienced in managing clinical and commercial labeling for diverse products, Artixio provides high quality services to supporting our clients' labeling and artwork requirements.  

  • Target Product Profile 

  • Core Data Sheet Authoring and Management 

  • Core Safety Information Authoring 

  • Literature Search and Re

bottom of page