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Hello Everyone
I am working on a new API submission with NPRA (Malaysia). I read the Drug Registration Guidance Document: Appendix 6 and understood that there are following three options to do the submission:
>>Option 1: Drug Master File
>> Option2: Certificates of Suitability
>> Option 3: Full details of Part II-S ACTD in the product Dossier
My queries are:
If I opt for Option1, Do I need to submit closed and open part both to the NPRA via CD only or still I need to send other docs like cover letter etc. as we do in USDMF submission??
And Can anyone please elaborate more on Option3 since I could not figure out any difference between Option 1 and Option 3 since the documents and the format required for both are the same. Please advise.
Looking forward to have some inputs. Thanks much!