Generic Drug Registration Process in Myanmar

Generic Drug Registration Process in Myanmar

Myanmar’s pharmaceutical market size was $456 million in 2017, with a percapita pharma expenditure of $8.5 and expected to reach $656 million in 2022. Myanmar’s economy is growing continuously, and the experts predict the pharmaceutical industry to quickly grow into a $1.12 billion industry in the future. Myanmar depends on the import of pharmaceutical products and remains a huge generic drug market for overseas manufacturers.

Myanmar depends on the import of pharmaceutical products and remains a huge generic drug market for overseas manufacturers. All kinds of prescription drugs, including steroids and antibiotics, can be purchased as over-the-counter (OTC) products.

India is a key trading partner of Myanmar. Indian generic firms such as Sun Pharmaceuticals, Dr. Reddy’s, Wockhardt, and Cipla are the big foreign companies operating in Myanmar and have a significant market share in Myanmar's local market.

In 2017, India (USD 181.5mn) was the main source for the importation of pharmaceutical products followed by Thailand (USD 46.8mn), Indonesia (USD 32.9mn), Singapore (USD 5.2mn), and China (USD26.5mn).

To register your generic drug in Myanmar, you need to know

  • Which is the regulatory authority in Myanmar to register your drug?
  • How can foreign manufacturers register their generic drugs in Myanmar?
  • How about Bioequivalence studies?
  • Is the foreign bioequivalence data acceptable in Myanmar?
  • What are the regulatory parameters & requirements to register your generic drug in Myanmar?
  • How about the manufacturing site accreditation, or other such requirements?
  • What are the timelines and costs involved in the generic drug registration in Myanmar?
  • What is the post-approval process such as importation and license to import?

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

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 Myanmar. 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.