Announcement
Update on Guidance Notes for Active Pharmaceutical Ingredients (API) Information for Product Registration - Version 6.1 (July 2022)
Written by Pharm Mee Ngoh · 28 July 2022
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:
|
Version |
Description of Updates |
Effective date |
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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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