Thailand Generic Drug Registration Process

Thailand Generic Drug Registration Process

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 support 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.

To register your generic drug in Thailand, you need to understand the following,

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

Get Details on Regulatory, Requirements, and Process for Registering Generic  Drugs in Thailand.

Credevo has prepared this report by collecting the relevant information as per the current understanding and awareness of Credevo. Click on the blue button below to download the report.

Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for registering generic drugs in Thailand. While the report can be considered as an informative resource, it is not being presented as legal guidance, a binding document, or any authoritative report. The information in this report was prepared based on relevant information from the public domain as of the date, however, the regulations and requirements may change with time and it is advisable to refer to current regulations at any given time. It is recommended to confirm the specific details, requirements, and processes applicable to your specific products at a given time before initiating any process of registration.