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 pharmaceutical industry is predicted to quickly grow into a $1.12 billion industry in the future.

In Myanmar, both non-communicable diseases and communicable diseases are more or less equally balanced. Two of the most disease seen are diabetes and cancer. Around 50% of the cases of diabetes are undetected in Myanmar. Along with this, cardiovascular diseases and HIV are also predominant. Hence, bringing opportunities to most of the generic drug manufacturers, especially overseas producers, and this disease trend is expected to continue in the long term.

Myanmar generic drug market

Myanmar is very dependent on imported pharmaceutical products. Myanmar is 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). 

Who can register the generic drugs in Myanmar?

  • Applications for registration of medicinal products must be submitted by an authorized representative of the product license holder. An authorized representative must be a resident of Myanmar.
  • In the case of a foreign company, the applicant must be a resident representative of the company and an authorization letter must be submitted by the foreign manufacturer to the local party.

Regulatory for Generic drugs in Myanmar

  • Generic products are considered as pharmaceutical equivalents of products already approved for marketing in Myanmar.
  • In Myanmar, the Food and Drug Administration (FDA) ensures the quality and safety of food, drugs, medical devices, and cosmetics in the country. FDA is responsible for the evaluation of pharmaceutical registrations.
  • Drug Control Division is one of the five major divisions of the FDA. The Drug control division is involved in activities such as registrations, inspection and licensing for manufacturing and import, drug sample collection and analysis, postmarketing surveillance. 

Generic Drug Registration Process in Myanmar

The APAC market for generic drugs is forecasted to grow US USD 112.86$ billion by 2025 from 75 billion in 2020 with a CAGR of 8.34% from 2020 to 2025. There is a growing demand for generic drugs in regions like Vietnam, Myanmar, Philippines, Laos, Brunei, etc.

The generic drug registration in these regions is simple but obtaining a clear regulatory process is difficult due to language barriers, lack of information availability, poor regulatory exposure, etc.

However, due to increased demands for registering drugs in these regions, we have seen a steep rise in requests for knowing the regulatory, requirements, and registration service.

To register your generic drug in Myanmar you need to know the following

  • 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.

Due to the interest of the manufacturers to register and market their generic drugs in Myanmar, we are receiving an increased number of queries.

To handle the queries for knowing the regulations and requirements for registering generic drugs in Myanmar we have created a report answering all the questions mentioned above, which describes the complete generic drug regulatory scenario in Myanmar.

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

What would you get by downloading this report?

  1. Details on the regulations, requirements, and process to register the generic drugs in Myanmar.
  2. Free assessment by Credevo to review your generic products and available data to know the applicable regulations.

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, Myanmar 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.

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Definition of the generic drug product

The generic drug is a product considered to be essentially similar or bioequivalent to a reference drug. These are drugs that are pharmaceutically equivalent but may or may not be therapeutically equivalent and are not covered by patent protection and which are labeled solely by their international non-proprietary name or generic name.

The requirements for the generic drugs vary based on the type and category of the generic drugs, Bioequivalence studies status, manufacturing accreditation etc.

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Application dossier requirements

Application dossier for registration has to be in compliance with the ASEAN Common Technical Dossier format. For generic drugs, the dossier involves Part I (Administrative documents and product information) and Part II documentation (Quality documents for drug substance and drug product).

Registration process

The registration process for the generic products can be summarized into the following steps

Prerequisites for submission of application

  • The first step is the submission of the list of products to the FDA for which the applicant intends to apply for registration. 
  • After that, the FDA issues a letter for the payment of assessment fees.
  • If the application is to register drugs manufactured overseas, the applicant has to request FDA approval for the importation of drug samples.
  • Applicants have to submit samples to FDA before submission of the application and within one week from the date of clearance. FDA checks the samples and issues a receipt with the date and reception number.

Submission of application

The applicant has to start a new application. Submission of the application. Application number will be generated automatically. There are some important points that need to be considered while making an application.

Evaluation and Approval

  • After submission, the applications are screened by DFDA-DCS and the applicant will be notified of the verification outcomes.
  • If the drug is approved for registration, the FDA will issue a letter of payment of registration fees for the issuance of the drug registration certificate.
  • The applicant has to do the payment within 90 days and upload the receipt through the online system.

Approval timeline

In Myanmar, the generic drug registration process usually requires approximately 9 months.

Registration fees

There are three types of fees such as registration assessment fee, registration fees, and variation of registration.

The fee for registration assessment is 300,000 Kyats with additional fees for Laboratory analysis.

Importation of drugs

  • The Ministry of Health regulates the drugs importation procedures. Only a resident of Myanmar or a corporation that is a generally licensed importer may import registered drugs.
  • In addition to this, the importer must have a specific registration certificate for pharmaceuticals known as a drug importation approval certificate, and a separate license is required per shipment issued by the Ministry of Commerce.
  • All imported drugs have to be registered and authorized by the Food and Drugs Administration (FDA) that inspects manufacturing sites and also tests the quality of drugs.

Do you have additional queries on registering your generic drugs in Myanmar
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References

  1. https://translate.google.com/translate?hl=en&sl=my&tl=en&u=https%3A%2F%2Fwww.fda.gov.mm%2F%3Fcat%3D20&prev=search
  2. https://www.myanmarinsider.com/myanmars-pharmaceutical-industry-promising-growth/
  3. https://oxfordbusinessgroup.com/overview/promoting-pharmaceuticals-health-care-provision-expands-demand-both-local-and-imported-20
  4. http://www.mtg.com.mm/fda/wp-content/uploads/2018/03/Guideline-for-Drug-Registration-Applicants-20JAN2018.pdf
  5. https://pharmexcil.com/uploads/countryreports/Myanmar.pdf
  6. https://www.mfds.go.kr/brd/m_617/down.do?brd_id=ntc0068&seq=33275&data_tp=A&file_seq=1
  7. https://www.tvpmyanmar.com/industryoverview.php?sub=19