New Guidance from Malaysia's NPRA 03 July 2023

The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia released a guideline on the control of nitrosamine impurities in pharmaceutical products on 3 July 2023. The guideline, based on EMA and FDA guidance, applies to all pharmaceuticals including biologicals which are intended for human use and contain chemically synthesized active pharmaceutical ingredients. The text of the guideline can be found at Pekeliling Berkenaan Kawalan Impuriti Nitrosamines Dalam Produk Farmaseutikal.