Thailand is the second-largest healthcare market in Southeast Asia after Indonesia making up roughly about 20% of the region’s expenditure.
Thailand’s pharmaceutical market is the eighth largest in the Asia Pacific region and considered one of the largest and most developed in ASEAN.
Top 5 reasons to choose Thailand as your generic drug market
Thailand’s Generic market presents numerous opportunities for foreign pharmaceutical companies
Thailand is a leading Hub of Generic Drugs for its
- Huge market size due to
- Aging population,
- The general trend in increasing risk of illness such as High blood pressure, Diabetes, Heart disease, Strokes, Cancer and communicable disease such as HIV/AIDS, Tuberculosis, Dengue fever, etc and
- Growth of medical tourism
- Support from the Thai government such as tax holidays and reduced import duties for equipment to foreign pharmaceutical investors
- New Regulations that no longer require state agencies to purchase from the Government Pharmaceuticals Organization (GPO), the state-run agency for pharmaceuticals and medical equipment providing a huge opportunity for foreign pharmaceutical companies.
- The Government of Thailand support for the usage of generics medicines in government-run hospitals
- Thailand hospitals purchase about 75% of all medicinal drugs fabricated and sold locally in Thailand usually based on Generic tenders 
Thailand vs other ASEAN countries
- The Thai Generic market is large and fast-growing, with the government remaining the biggest client for the industry.
- Entry into the Pharmaceutical Inspection Co-operation Scheme (PIC/S) which opens the way for Thai manufacturers of medicines and medical supplies to expand their exports to the ASEAN region
- The Board of Investment (BOI) (through tax exemption) is making an effort to invite pharmaceutical companies to invest in Thailand.
- Thailand highly imports pharmaceuticals and medical devices to overcome the needs of the healthcare sector and Thailand imports about 90% of the ingredients used to produce the final products. 
Need support for your drug registration in Thailand?
Credevo offers expertise in drug product registration, clinical trial regulations, and many more services in Thailand. Talk to our experts now.
Potential therapeutic area for generics in Thailand
- Communicable diseases such as
- Requiring Antibiotics,
- Other infections etc
- The highest value medicines, such as
- Analgesics and
- Medicines for treating fevers
- The potential Non-Communicable disease market which has demand for drugs include
- Kidney disease and
- Heart disease
Thailand pharmaceutical market size
- According to the Thai Board of Investment, the Thai Pharmaceutical Market value is 4.6 Million US$ in 2016 and expected to be doubled by 2020
- The Domestic market has about 160 companies which import Pharmaceutical ingredients, produce and sell them as Generic to Thai consumers and Market value is estimated to be 1 Million US$
- The export of Pharmaceutical products has grown steadily over the years and most Pharmaceuticals were exported to ASEAN regions like Myanmar, Vietnam, Cambodia, etc
- Almost 90% of Pharmaceutical trade comes from Generic drugs and Generics are mainly imported from China, India, United States, Germany, France, and Switzerland 
Global footprints in Thailand
Prominent foreign pharmaceutical companies that operate in Thailand include GSK, Sanofi, Roche, AstraZeneca, and Novartis
Some of the Foreign pharmaceutical companies also manufacture products in Thailand.
- PharmaCyte Biotech (Laguna Hills, CA) announced that the company would be using Austrianova’s existing live-cell encapsulation facility in Bangkok.
- Teva Pharmaceutical (Israel) owns a Thai generics manufacturer, Silom, after acquiring Actavis in 2016.
- Not only multinational drug firms have made investments in in-country facilities but even foreign pharmaceutical companies generally employ several large Thai contract manufacturers to either re-package their imported drugs or produce their products locally. 
Requirements & procedure to register generic drugs in Thailand
- Regulatory Body: The Drug Control Division of the TFDA (Thai Food and Drug Administration) is responsible for registration, licensing, surveillance, inspection and adverse event monitoring for all pharmaceuticals and pharmaceutical companies in Thailand
- Application Format: Format followed for submission & Drug registration is ACTD (ASEAN Common Technical Document) and additional country-specific requirements
- Type of Application: Registration requirements differ for general drugs such as generics, new medicines, new generics, and traditional drugs.
Type of generic drugs
- Generic drug
- New generic drug
The Pharmaceutical products with the same active ingredients and the same dosage forms as those of the original products, but manufactured by different manufacturers are considered as Generics
Registration requires only dossiers on product manufacturing and quality control along with product information
Applications are made to the FDA
- Step 1: Companies and individuals wishing to enter a drug on the market must obtain a license from the FDA to manufacture, sell or import drugs in Thailand.
- Step 2: Application for approval of drug quality control and analytical methods. (at Department of Medical Science)
- Step 3: Then the licensed applicant must obtain FDA registration for the medicine to market and sell the drug in Thailand.
- The applicant should submit various details about the drug production process to be used, including:
- Manufacturing methods.
- In-process controls.
- Specifications of the active ingredients
- Excipients used in the production process
- To register new generics, the FDA requires dossiers of bioequivalence studies, in addition
- Information about the drug storage conditions and details about the stability of the drug is also required
New Generic Drug
Medicines with the same active ingredients, doses and dosage forms as those of the new compounds registered after 1992 are considered as New Generics
- Registrations require dossiers of bioequivalence studies in addition to the required dossiers for generics submission.
- A protocol on bioequivalence study must be submitted for approval at the Drug Control Division.
- Application to seek permission for import or manufacture the drug samples.
- Performing the bioequivalence study according to the approved protocol in a specified government institute.
- Submitting an application for registration along with the bioequivalence report and other useful documents. 
Generic & New Generic Comparison
|Type||Generic drug||New Generic Drug|
|Dossier Requirements||1. Product Manufacturing|
2. Quality Control
3. Product Information
|1. Bioequivalence Studies|
2. Product Manufacturing
3. Quality Control
4. Product Information
|Process||1. Obtain a license from the FDA to manufacture, sell or import drugs|
2. Application for approval of drug quality control and analytical methods
3. Obtain FDA registration for the medicine to market and sell the drug in Thailand
|1. A protocol on bioequivalence study for approval at the Drug Control Division|
2. Obtain a license from the FDA to manufacture, sell or import drugs
3. Application for approval of drug quality control and analytical methods
4. Obtain FDA registration for the medicine to market and sell the drug in Thailand
|Timeline||4-5 Months||5-6 Months|
Review fast track
Drug application for generics can be processed in either of the two-track depending on the need by the patients
- Track 1: Standard view which takes approximately 110 working days
- Track 2: Accelerated or Priority Review (Drugs for public health problems/life-threatening) which takes about 70 working days 
Requirements for drug registration in Thailand
- Administrative Documents
- Drug Product
- Non Clinical Documents
- Clinical Documents 
|Administrative Documents||Drug Product||Non Clinical Documents||Clinical Documents|
|1. Application Form|
2. Copy of Valid Certificate of Brand Name Clearance
3. Certificate of a pharmaceutical product (COPP)
5. License For Pharmaceutical Manufacturing
6. Site master file (SMF)
7. Permission For Manufacturing & Marketing
8. In Country of Origin
9. Letter of authorization (LOA)
10. Labeling Documents
11. Patent Information
Patient information leaflet (PIL)
13. Mock Up And Specimen
14. Environmental Risk Assessment (Depends)
|1. Description & Composition|
2. Pharmaceutical Development
4. QC of Excipients
5. QC of Finished Product
6. Reference Standard
7. Container Closure System / Packing
8. Product Stability
9. Product Interchangeability
|1. Non Clinical Overview|
2. Literature References
|1. Clinical Overview|
2. Clinical Study Reports (Only Bioequivalence)
Thailand current and future market
- According to the IMF (International Monetary Fund), Thailand’s GDP based on Purchasing Power Parity (PPP) exceeded $1.1 trillion dollars in 2016, making Thailand the second largest economy in Southeast Asia after Indonesia, which has a GDP of $3 trillion.
- Thailand imported over $2.2 billion in pharmaceuticals in 2016, an increase from $1.8 billion in just two years ago and in 2016, over 65% of Thailand’s pharmaceutical imports came from the United States, Europe, and Canada and Germany is also a largest pharmaceutical exporter to Thailand, followed by the US, France, then Switzerland.
- The Thai pharmaceutical market was valued at over $5 billion in 2016 and the current value of $7 Billion making it the second-largest market in Southeast Asia and the value of Thailand’s pharmaceutical market is expected to double by 2020.
- Revenue in the OTC Pharmaceuticals market amounts to US$ 990m in 2019. The market is expected to grow annually by 0.7% (CAGR 2019-2023) and Pharmaceutical sales per-capita are also predicted to grow from $75 in 2016 to $125 by 2024. 
Do you need support or do you have queries on drug registration requirements?
Credevo offers a wide range of drug development and regulatory services in Thailand. Provide your query details below to connect with us.