Myanmar Generic Drug Registration Process
Myanmar’s pharmaceutical market size was $456 million in 2017, with a percapita pharma expenditure of $8.5 and market researchers expect 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.
Note: This article was updated in September 2022.
Both non-communicable diseases and infectious diseases are more or less equally balanced. Two of the most disease seen are diabetes and cancer.
Along with this, cardiovascular diseases and HIV are also predominant. Hence, this brings opportunities to most the generic drug manufacturers, especially overseas producers, and this disease trend is expected to continue in the long term.
Myanmar generic drug market
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. They 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?
- An authorized representative who is a product license holder shall submit applications to register, and he needs to be a resident of Myanmar.
- For a foreign company, the applicant must be a resident representative of the company and need an authorization letter from the foreign manufacturer to the local party.
Regulatory for Generic drugs in Myanmar
- Myanmar considers generic products 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 involves activities such as registrations, inspection and licensing for manufacturing and import, drug sample collection and analysis, post marketing surveillance.
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.
Definition of the generic drug product
A generic drug is a product that is essentially similar or bioequivalent to a reference drug. These drugs are pharmaceutically equivalent but may or may not be therapeutically equivalent and don’t cover patent protection. These drugs are labeled solely by their international non-proprietary name or generic name.
The requirements for generic drugs vary based on the type and category of the generic drugs, Bioequivalence studies status, manufacturing accreditation, etc.
Application dossier requirements
The application dossier for registration has to comply with the ASEAN Common Technical Dossier format. Generic drugs dossier contains Part I (Administrative documents and product information) and Part II documentation (Quality documents for drug substance and drug product).
The process to register for the generic product can be summarized into the following steps
Prerequisites for submission of application
- The first step is to submit the list of products to the FDA for which the applicant intends to apply for registration.
- After that, the FDA issues a letter for assessment fee payment.
- If the application is to register drugs manufactured overseas, the applicant has to request FDA for the import 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 sample and issues a receipt with the date and reception number.
Submission of application
The applicant has to start a new application and needs to obtain an application number automatically. The applicant needs to consider the following points to make an application.
Evaluation and Approval
- After submission, the DFDA-DCS screens the application and notifies the applicant about the verification outcomes.
- If the FDA approves the drug, it issues a letter of payment of registration fees for the issuance of the drug registration certificate.
- The applicant has to complete the payment within 90 days and upload the receipt through the online system.
In Myanmar, the generic drug registration process usually requires approximately 6-12 months. Validity of registration is 5 years.
- 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 and an additional fee for Laboratory analysis.
Importation of drugs
- The Ministry of Health regulates drug importation procedures. Only a resident of Myanmar or a corporation with a license for import may import registered drugs.
- In addition, the importer must have a specific registration certificate for pharmaceuticals known as a drug importation approval certificate and needs to have a separate license for each shipment issued by the Ministry of Commerce.
- The applicant needs to register and gain authorization from the Food and Drugs Administration (FDA), which inspects manufacturing sites and tests the quality of drugs.