Malaysia – Malaysia Provides Guidance on Regulatory Control of Atypical APIs

The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has shared guidance on atypical active pharmaceutical ingredients (APIs). NPRA expects companies to show batches of atypical APIs comply with specifications set by the finished product manufacturer before they are used.

Version 1.0 of the Malaysian API guidance came into force in April 2018. A section on how the rules applied to ingredients registered before the country implemented a regulatory control directive was added months later. Now, NPRA has updated the guidance for a second time, adding a section on the regulatory control of excipients, food additives and cosmetic ingredients used as APIs in medicines.

When used in medicines, these materials are known as atypical APIs. This subcategory of APIs poses a lower risk than conventional active ingredients, according to NPRA, and is widely used outside the pharmaceutical industry…