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Hello everyone
I am working on DMF Submission for an API in Malaysia. I have read the DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) Appendix 6 (
https://npra.gov.my/easyarticles/images/users/1047/Drug-Registration-Guidance-Document-DRGD-Second-Edition---July-2020-Revisio_20200910-01Septh_1.pdf) and understood that there are following three options to submit the API with NPRA
>>Option 1: Drug Master File (DMF)
>>Option 2: CEP
>> Option 3: Asean Common Technical Dossier (ACTD)
My Queries are: If I opt for Option1: DMF, Do I need to file the complete DMF i.e. Closed and Open part with the agency via CD only or is there any other sections also I need to submit like any cover letters etc. as we do in Module-1 in USDMF submission??
And Can someone please elaborate on Option 3?? I could not understand and find the difference between Option 1 and Option 3 since the information required for Option 2 and Option 3 is mostly same. Please advise. Is this is my first Asian Market submission.
Thanks in advance.