Regulatory requirements for the approval of Anti-Cancer drug (Mercaptopurine) in Myanmar as per ACTD
South East Asian pharmaceutical market is growing rapidly. In Asian country, The regulatory environment is similar among all countries. But still requirements and process of registration is varying among countries of Asian region. Although ACTD is harmonized for all ten countries but still every country differ in some of the local requirements such as administrative, technical, clinical and non clinical documents. Among this country Myanmar systematically regulate the manufacture, import, export, storage, distribution and sale of drugs. Aim of the present study is To discuss emerging challenges and requirements posed by compulsory licensing for drugs in diseases such as cancer. In this article we have observed documents requires for registration of Mercaptopurine drug belonging to anti – cancer category in Myanmar. Documents like batch manufacturing record, process validation records, stability study which include long term and accelerated stability studies as per zone specification of Myanmar, packing requirements for anti – cancer drug and certificate for product permission required for registration, which has covered all aspects from manufacturing to its packing and registration. This article will give the easy understanding on the drug registration requirements for anti – cancer drug such as Mercaptopurine in Myanmar.
2. The ASEAN (Association of Southeast Asian Nations) group of nations, namely Indonesia, Malaysia, Philippines, Singapore, Thailand, Brunei Darussalam, Vietnam, Laos, Myanmar and Cambodia [Internet]. 2013 [Cited 2013 Jan 11]. Available from:
3. Nagaraju P, Flary N, Kumar BM, Nagarjuna Reddy D and Nagabhushanam MV. Comparison of generic drug registration requirements in ASEAN countries. IJRPC. 2015; 5(1):145-9.
4. Thida A and Finch J. Pharmaceuticals in Myanmar - Law and Procedure. Singapore Journal of International and Comparative Law. 2000; 115-47.
5. All pharmaceuticals/drugs require a product license to import or sell in Singapore [Internet]. 2013 [cited 2018 Feb 21]. Available from:
6. A Guideline on Drug Registration Application [Internet]. 2014 [cited 2014 Apr 22]. Available from:
7. Dixit PB & Dilip M. Regulatory Requirement for the Approval of generic Drug in Thailand as per ASEAN Common Technical Dossier (ACTD) - A Review. JPSBR.2014; 4(4):243 -51.
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