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 is 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 supports 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) 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.

How To Start Process For Generic Drug Registration In Thailand?


Follow the below steps for registration of generic products in Thailand!

Step 1: Understand the regulations and requirements to register generic drugs in Thailand

Credevo has prepared a ready-to-refer Report on the Regulatory Process, Requirements and General Cost and Time Considerations for Registration of Generic Products in Thailand

👉 Click here to download the report

Step 2: Get free assessment of your product details with Credevo to confirm the applicable process, requirements, documents and cost of registration of drug product in Thailand

Step 3: Provide the required documents to Credevo to start the registration process

Potential therapeutic area for generics in Thailand

  • Communicable diseases such as
    • Requiring Antibiotics
    • HIV/AIDS
    • Tuberculosis
    • 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
    • Hypertension
    • Diabetes
    • Cancer
    • 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 that import Pharmaceutical ingredients, produce and sell them as Generic to Thai consumers and the 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.

Generic drug regulatory 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: The 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.
  • Documents required
    • Administrative Documents
    • Drug Product
    • Non Clinical Documents
    • Clinical Documents

Type of generic drugs

  • Generic drugs
  • New Generic drugs

Generic Drugs

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.

New Generic Drugs

Medicines with the same active ingredients, doses, and dosage forms as those of the new compounds registered after 1992 are considered as New Generics.

Process to register generic drugs in Thailand

Given the various rules and regulations, different categories of drugs, and different requirements for each drug category, one may wonder how to start the process of filing the application.

The process to register generic drugs in Thailand can be considered in 4 steps, as follows.

  1. Understand the regulations, requirements, and process.
  2. Review the product details to confirm the drug class and applicable considerations.
  3. Collect and submit all the details, information, certificate, and data, as per the product review, to the regulatory team for submission.
  4. Respond to queries and receive the product registration.

Step 1: Understand the regulations, requirements, and process of generic drug registration in Thailand

This involves collecting information on the different regulatory aspects related to generic product registration. One can start by finding answers to the below questions related to the overall process of registration in Thailand.

  1. What are the different categories of generic drugs in Thailand?
  2. Which category does a specific product belong to?
  3. What are the documents required to register the specific category of generic drugs?
  4. What is the applicable accreditation or certification required for generic drug registration in Thailand?
  5. Are bioequivalence studies required to register the generic drug in Thailand?
  6. Who can register the generic drugs in Thailand and/or hold the marketing authorization for a specific drug in Thailand?
  7. What is the overall process applicable for registering a specific generic drugs in Thailand?

Answers to all such questions and information on the complete process of registration of drugs in Thailand can be obtained from the following ‘Report on the Process of Generic Drug Registration in Thailand‘, provided by Credevo.

Thailand Generic Drug Registration Process
What would you get by downloading this report?
  1. Details on the regulations, requirements and process to register generic drugs in Thailand.
  2. Free assessment of your drug product by Credevo to check specific requirements applicable for its registration.
  3. Discount of $100 in service charges for registration, while availing services from Credevo.
You’ll be able to get help on following questions related to Thailand generic drug registration.
  1. What are the different categories of generic drugs in Thailand?
  2. Which category does a specific product belong to?
  3. What are the documents required to register the specific category of generic drugs?
  4. What is the applicable accreditation or certification required for generic drug registration in Thailand?
  5. Are bioequivalence studies required to register the generic drug in Thailand?
  6. Who can register the generic drugs in Thailand and/or hold the marketing authorization for a specific drug in Thailand?
  7. What is the overall process applicable for registering a specific generic drugs in Thailand?
$100

Note: Do not forget to note the Transaction ID after downloading the report in order to receive the following benefit.


Step 2: Review the product details to confirm the drug class and applicable considerations

While there are many common requirements applicable to the registration of generic drugs in Thailand, some requirements are specific to the category of generic drugs that a specific product belongs to.

It is extremely important to identify the category and specific requirements applicable to the product, not only to comply with the regulations but also to identify the fastest way to secure the approval.

If you have downloaded the above referred ‘Report on the Process of Generic Drug Registration in Thailand’, just fill up the information below to receive a free assessment of your drug product details by Credevo to check specific requirements applicable for its registration.
Free assessment of drug product for Thailand registration
This form will be submitted by user after buying the report on generic drug registration process in Thailand
Provide the transaction ID received while downloading 'Report on the Process of Generic Drug Registration in Thailand'
Provide your work email, which you used while downloading the report.

With this assessment, you can also choose to receive a cost proposal for the registration of your drug product. If you’d like to proceed with the registration, you can go ahead with the next step.


Step 3: Collect all the details, certificates, and data, as required

With the requirements ascertained in step 2, collect all the information required.

This may include information like

  • Dossier as per the specified format
  • Results from specified testing
  • Data on the product
  • Accreditations and certifications.

Your regulatory team will utilize this information to submit the application on your behalf.


Step 4: Submit and respond to queries and receive the product registration

Once the application has been submitted, Thai FDA officials will start the review process.

During this review time, if there are any queries, you will be notified and will need to respond within timelines.

Generally, the approvals received from the FDA include the following, before you can start selling your product in Thailand.

  1. A license from the FDA
  2. Approval of drug quality control and analytical methods
  3. Obtain FDA registration for the medicine to market and sell in Thailand

Process flow

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.

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 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 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 the 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 have additional queries on Thailand generic drugs, e.g. BE study design, study management, dossier preparation or PIC/S accreditation?

Send us a message below. Credevo has an excellent team of experts on the ground to assist with the generic drug registration in Thailand.

Provide your work email, where we can contact you

Reference

  1. https://www.pacificbridgemedical.com/publication/thailand-drug-market-update-2017/
  2. https://www.business-sweden.se/contentassets/18717dc559704fe98f03af9de7b70a60/opportunies-in-thailands-healthcare-sector.pdf
  3. https://www.business-sweden.se/contentassets/c5a46df88398454490c8e4ce4934d1da/capture-the-business-opportunities-in-thailand-2018.pdf
  4. https://www.boi.go.th/tir/issue/201507_25_7/42.htm
  5. https://pharmaphorum.com/views-and-analysis/thailand-pharmaceutical-market-update-2014/
  6. https://www.statista.com/outlook/18000000/126/otc-pharmaceuticals/thailand
  7. https://ijdra.com/index.php/journal/article/download/158/77
  8. http://www.indianembassy.in.th/pdf/Market%20Survey%20Thailand%20Pharmaceutical%20Industry%202017.pdf

Comments are closed.