REPUBLIC OF The UNION OF MYANMARDrug Registration Procedure in Myanmar Dr.Aye Nyein Myat Dr. Myo Zarni Saw Control Officers (Drug) Food and Drug Administration Department Department of Health
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
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)
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
Registration Procedure in Myanmar Flow Chart for Drug Registration ApplicationApplicant• Guideline for drug registration application• Asapsessment fees paid to bank (US$ 100)• Submit application in prescribed form and dossier• Submit samples
Registration Procedure in MyanmarFDA• 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
Registration Procedure in MyanmarApplicant• Registration fees paid to bank (US$ 300)• Registration Certificate received
Registration Procedure in MyanmarFees 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.
Registration Procedure in MyanmarDossier Requirements•To implement the ASEAN common technical Dossier (ACTD) Starting January, 2009.• Required dossiers can be available in our guidelineon drug registration application (updated in 2012)
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.