Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated its variation guideline for pharmaceutical products, reflecting revisions to the Association of Southeast Asian Nations’ (ASEAN) position on the topic.
NPRA published the first version of the guideline in 2013. Since then, ASEAN has made two rounds of changes to its variation guideline for pharmaceutical products, first in 2019 and then in 2021. The ASEAN-related revisions affect the reclassification of two variation types, the addition of new variation types and changes to existing variation types.
Most of the changes relate to the addition of new variation types. The new types listed by NPRA in its summary of the revisions include addition of a primary packaging site for non-sterile drug product, change of drug substance submission option and update of the good manufacturing practice certificate.
NPRA made some other changes unrelated to the ASEAN update, including timeline revisions. NPRA will issue first correspondence or approval for single major variations within 60 working days. If variations, including a major variation, are grouped, NPRA will take up to 100 working days to issue first correspondence or approval.
SCOPE OF THIS GUIDELINE
This Malaysian Variation Guideline concerns the variation applications submitted by the PRH for pharmaceutical products for human use only. It is intended to provide supportive information on the requirements for submission of a variation application to implement a change to a pharmaceutical product. There are separate guidelines for biological products, traditional medicines and health supplement products.
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