Drug registration must be initiated by entering a list of drugs that the applicant wishes to register in a registry book at Drug Control Section 1 (‘DCS1’), part of the FDA. The notification will be made only on the notice board of FDA. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA (a) When the drug is approved for registration, the applicant will be notified to remit 300 United States Dollar as Registration Fees. Drugs@FDA includes most of the drug products approved since 1939. Officials from the FDA affirmed that Fluarix Tetra 2020 Influenza vaccines are not included on their list of overseas pharmaceutical drugs registered in Myanmar. (a) If it is an application for registration of drugs manufactured outside Myanmar, the Food and Drug Administration will issue “ Approval for 8. Registration assessment fees; 300000 Kyats must have been remitted to MD account of Department of Food & Drug Administration when submission of the application form is made. Internationally, Pyramax is registered in twenty-six countries with high malaria burden and locally registered by the Ghana Food and Drugs Authority since March 2020 for the management of uncomplicated malaria. To enhance accessibility in Low- and Middle-Income Countries, the Global Fund has also included Pyramax in its list of drugs. The Republic of the Union of Myanmar. Attachment-> : FDA Advisory No. Year . Asia's one-stop resource for medical news, clinical reference and education Registered Companies . The Myanmar FDA has advised people to buy and consume only flu vaccines which are approved by the FDA and with the recommendation of physicians and doctors. The “National Drug Law (1992)” is currently the only legislation available for medical goods, and there are no specific regulations pertaining to medical devices. 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 Myanmar was also put back of the US Financial Action Task Force’s “grey list” in 2020 in response to signs of ethnic cleansing of the Rohingya in Rakhine state. Background. For more information and inquiries, please e-mail us at info@fda.gov.ph. The Myanmar Ministry of Health’s Food and Drug Administration (MFDA) oversees the safety and quality of medical devices and pharmaceutical drugs within the country. Data & Statistics Month . Type Title File Size ; pdf. 2019-188 × The “grey” and uncertain picture for US companies was one of the reasons that Herzfeld & Rubin PC decided to shut up shop in Yangon in 2017. (b) Failure to remit registration fees within 90 days from the date of intimation will constitute forgoing of an application by an applicant. 7. The DCS1 will then issue a letter of intimation for remittance of assessment fees, which amount to US $100 plus fees in kyats for laboratory analysis, depending on the To report continuous sale or distribution of the above unregistered food product, e-mail us via report@fda.gov.ph, or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8112 or 8105.