The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has published the second edition of the variation guideline for pharmaceutical products in July 2022.
The latest guideline has been updated in accordance with the ASEAN Variation Guideline for Pharmaceutical Products (Revision 1 & 2) and some country-specific requirements.
There are 17 new variation types, along with some reclassification and amendments to existing ones. Some new variation types include change of drug substance submission option, update of the Certificate of Pharmaceutical Product (CPP), and update of information following approval of Additional Indication.
Timelines for grouping of variations have been newly added for submissions involving multiple variation types. For applications that include a major variation application type (MaV), the timeline for the first correspondence or approval is 100 working days, whereas if the application does not include a MaV, the timeline is 80 working days.
More details can be found in: “Malaysian Variation Guideline for Pharmaceutical Products, 2nd edition, July 2022”: https://npra.gov.my/easyarticles/images/users/1131/MVG-for-Pharmaceutical-Products-2nd-Edition-July-2022.pdf