Drug Registration Process in Myanmar

Ministry of Health 

Ministry of Health

Regulatory Authority 

Food and Drug Administration, Myanmar

Link for Regulatory Authority 

https://www.fda.gov.mm/

Language 

Burmese/English

Local Authorised 

Yes

Listing or Registration Requirements

Drug type (new drug, generic drug, innovative product), Registration pathway (aiming for full registration, local listing, shadow registration), Novelty, Risk profile, ASEAN Common Technical Dossier.

Registration Timeline 

6-12 Months

Fee

• Registration Assessment Fees: 300,000 Kyats + Fees for Laboratory analysis.
• Registration Fees: 500,000 Kyats.
• Variation of Registration: 100,000 Kyats for each variation

License Validity

5 Years

Overview of Drug Registration Process in Myanmar

The process of drug registration in Myanmar involves a meticulous processing step to ensure the safety, efficacy, and compliance of pharmaceutical products. As of 26th February 2018, the Department of Food and Drug Administration (FDA) has implemented an online submission system, revolutionizing the application process. 

In this guide, we break down each stage of drug registration, from the initial application to variations and renewals. The FDA has released detailed guideline on Drug Registration Application.

1. Initial Application for Registration

1.1 Application Submission (Form I Registration)

The application process begins with the submission of the drug registration application in the prescribed form, known as Form, I Registration. Applicants must use the mandatory online facility at https://user.dcdfdamm.online. Detailed guidance on using the online application facility is provided in Annex VIII.

A separate registration application should be submitted for pharmaceutical preparation varied strengths, dosage or size.

1.2 Dossier Submission

After the online submission is screened and found receivable by the FDA, applicants are required to submit a physical dossier within 60 days. Failure to meet this deadline forfeits the application. The physical dossier, consisting of Form (I) and accompanying documentation, must adhere to a specified order, as listed in “Documents Required for Registration of Drugs” (Annex I).

1.3 Application Review and Fees

An authorized representative, who must be a resident of Myanmar, is responsible for submitting the application in person. Registration assessment fees of 300,000 Kyats are to be remitted to the FDA’s bank account before submission. Applications containing active substances not marketed in Myanmar require authorization from recognized regulatory authorities or prequalification by the World Health Organization.

1.4 Importation Approval for Drug Samples

For drugs manufactured outside Myanmar, an “Approval for Importation of Drug Samples” (Annex II) is issued upon application. Samples must comply with specified conditions and Trade and Customs Department regulations.

1.5 Evaluation Process

The evaluation process commences only when all requirements are met, including the remittance of fees, a complete set of documents, and enough good shelf-life drug samples.

1.6 Registration Approval and Fees

Upon approval, applicants are notified to remit 500,000 Kyats as Registration Fee within 90 days. Failure to comply results in the forfeiture of the application, with no return of assessment fees or registration documents.

1.7 Certificate Issuance

The Drug Registration Certificate is issued only after the acknowledgement of receipt of payments submitted to the FDA.

1.8 Irreclaimable Submissions

It’s crucial to note that submitted dossiers and fees are not reclaimable in case of rejection or forgoing of application.