1. REPUBLIC OF The UNION OF
MYANMAR
Drug Registration Procedure
in Myanmar
 Dr.Aye Nyein Myat
 Dr. Myo Zarni Saw
 Control Officers (Drug)
 Food and Drug Administration Department
 Department of Health

2. Pharmaceutical
Administration in Myanmar
 To protect the public from unsafe drugs-
 1992 October - National Drug Law
 1993 August Notifications --Registration,
manufacturing, sales, distribution,
importation, labelling and advertisement
 Administrative committee - MFDBA, CFDSC
 Technical committee - DAC

3. Pharmaceutical
Administration in Myanmar
 FDA - in 1995
 Drug control activities- under guidance
of MFDBA
 Registration, Manufacturing ,
Importation Sales and Distribution ,
Labelling and Advertising are
regulated and controlled by Myanmar
Food and Drug Board of Authority
(MFDBA)

4. ORGANIZATIONAL STRUCTURE FOR FOOD AND DRUG CONTROL ADMINISTRTION IN MYANMAR
Cabinet of ministers
MFDBA Ministry of health
chairman
Department of health
CFDSC DAC FAC Director General
Director
FDA
State/Division (secretary) Deputy Director
FDSC Deputy Director (Food)
(Drug)
District FDSC AD AD AD AD AD AD
(Drug (lab service) (Medical device (Food (Lab (Bio &chemical
&safety lab) safety lab)
control) control) service)
Township FDSC

5. Registration Procedure in Myanmar
Flow Chart for Drug Registration Application
Applicant
• Guideline for drug registration application
• Asapsessment fees paid to bank (US$ 100)
• Submit application in prescribed form and dossier
• Submit samples

6. Registration Procedure in Myanmar
FDA
• Review documents
• Conduct evaluation
• Prepare a list of complete and assessed applications
• Submit to DAC Meeting for Submission and
Consideration for Acceptnce/Rejection
• Laboratory Analysis & Confirmatory aClinical Trial
• Submit to DAC Meeting for Approval
• Submit to MFDBA for Confirmation

7. Registration Procedure in Myanmar
Applicant
• Registration fees paid to bank (US$ 300)
• Registration Certificate received

8. Registration Procedure in Myanmar
Fees Levied
 Registration Assessment Fees
-100 US$ + Fees (in Kyats) for laboratory
analysis
 Registration Fees - 300 US$
 Variation of Registration- 100 US$
Note: (1) & (2) are levied either for fresh
registration or renewal of registration.

9. Registration Procedure in Myanmar
Dossier Requirements
•To implement the ASEAN common technical
Dossier (ACTD) Starting January, 2009.
• Required dossiers can be available in our guideline
on drug registration application (updated in 2012)

10. Registration Procedure in
Myanmar
 Registration Validity
 The period of validity of registration certificate is 5
years and renewal for registration application shall
be submitted 90 days before the validity of
registration terminates.
 Application procedure and the documentary
requirement (except the sample amount) is the
same as initial registration but information has to be
updated.

11. Thank You