Update on Guidance Notes for Active Pharmaceutical Ingredients (API) Information for Product Registration - Version 6.0 (March 2021)

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Please be informed that there has been an update on the Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration. The updated document is available for download:



The summary of changes on Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration are outlined below:



Description of Updates

Effective date

Version 6.0

Rearrangement of topics title. Topics which are incorporated in updated DRGD (Third edition, Jan 2021) are removed from this Guidance Notes.


Addition of Part D: Mode of Submission for Drug Master Files (DMFs)


Addition of Part E: Product Registration Application Referencing to WHO Prequalified APIs


Updating of Appendix I: Addition of WHO PQ requirements


Updating of Appendix IV: Addition of Cetylpyridinium Chloride, Mannitol and Malic Acid as examples of Atypical API


Editorial changes:

-   DRGD Appendix 6 changed to DRGD Appendix 11


-       Change of label of Appendixes of Guidance Notes from 1, 2, 3, 4 & 5 to I, II, III, IV & V

March 2021


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