Update on Guidance Notes for Active Pharmaceutical Ingredients (API) Information for Product Registration - Version 6.1 (July 2022)

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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 6.1

Updating of Appendix IV: Addition of Lysine Hydrochloride,          Taurine, Histidine Hydrochloride Monohydrate, Potassium Acetate,                          Sodium Dihydrogen Phosphate Dihydrate, Fish Oil (Rich in Omega-3-Acids) & Magnesium Acetate as examples of Atypical API.

July 2022



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