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Drug Registration Process in Myanmar

Ministry of Health Mozambique's Medicine Registration- Mozambique National Medicines Control Authority (NMCA)

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 authorised 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. 

2. Updating Changes to Registered Drugs (Variations)

2.1 Application Process

Any changes to registered drugs must be approved by the FDA. The Registration Certificate holder applies for a variation, providing reasons, relevant data, and the effect of changes on drug specifications.

2.2 Submission Requirements

Submission includes an attestation from the country’s drug regulatory authority approving changes, a photocopy of the Drug Registration Certificate, and a 100,000 Kyats fee per variation.

2.3 Fee Waiver Possibility

The Drug Advisory Committee may waive the fee if the variation is deemed beneficial to the public regarding quality, safety, and efficacy.

3. Renewal of Registration

3.1 Timely Submission

Renewal applications must be submitted 90 days before the registration validity expires to avoid disruption.

3.2 Application Process and Fees

Renewal follows the same procedure as new registrations, including the submission of required samples and updated information. Registration assessment fees must be remitted during renewal application, and upon approval, a 500,000 Kyats Registration Fee is levied.

3.3 New Registration Number

Upon approval, a new Registration Number is designated, rendering the old one null and void.

3.4 Consequences of Non-Renewal

Failure to apply for renewal results in the invalidation of registration, effective from the certificate’s expiry date.

Documents required for product registration

Part I: Administrative Documents and Product Information

  • Application forms: This includes Form I (Registration Application) and any other relevant forms specified by the DFDA.
  • Company documents:
    • Certificate of Business Registration for local companies.
    • Attestation by the product owner on compliance with manufacturing procedures.
    • Product Owner Company Profile.
    • A statement describing the duties and responsibilities of each manufacturer.
    • Certificate of NRA of the country of origin showing acceptance of more than one manufacturer (if applicable).
    • Manufacture licenses with conditions, if applicable.
    • Manufacture profile including details of manufacturing site and facilities.
  • Product information:
    • Product name and brand name.
    • Chemical and pharmaceutical data.
    • Dosage form and characteristics.
    • Accompanying reconstitution diluent(s), if any.
    • Composition with details of each component and its function.
    • Indications and therapeutic uses.
    • Dosage and administration instructions.
    • Contraindications, warnings, and precautions.
    • Adverse reactions and side effects.
    • Labelling information, including package leaflet and product label designs.

Part II: Quality Documents for Drug Substance and Drug Product

  • Manufacturing details:
    • GMP certificates for the manufacturing plant(s) of the drug substance and drug product.
    • Process flow charts for the manufacture of the drug substance and drug product.
    • Specifications for the drug substance and drug product.
    • Analytical reports for the drug substance and drug product.
    • Stability data for the drug substance and drug product.

Additional Documents:

  • Fees as required by the DFDA.
  • Enough good shelf-life drug samples (at least two-thirds of shelf-life at lot release).
  • Any other documents requested by the DFDA during the review process.

Labelling and Packaging:

Ensure that the approved drug product complies with labelling and packaging requirements set by the FDA.

Post-Market Surveillance:

Once the drug product is on the market, post-market surveillance activities may be required to monitor its safety and effectiveness.