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MALAYSIAN (NPRA): VARIATION GUIDELINE FOR PHARMACEUTICAL PRODUCTS

The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has updated its variation guideline for pharmaceutical products to be in line with recent revisions to Association of Southeast Asian Nations’ (ASEAN).


In this guidance the Two variation types have been reclassified, new variation types have been added, and existing variation types have been modified.

This Malaysian Variation Guideline concerns the variation applications submitted by the product registration holder (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.

Throughout the life of a pharmaceutical product, the product registration holder (PRH) is required to take into account technical and scientific progress, and to make any amendments that may be required to enable the pharmaceutical product to be manufactured and checked by means of generally accepted scientific methods.

Such amendments, regardless of their nature, are referred to as variations and have to be approved by National Pharmaceutical Regulatory Agency (NPRA).


Variation applications are categorized into major variation, minor variation (prior approval) and minor variation (notification)

  • Major variation (MaV) Variation to a registered pharmaceutical product that may affect significantly and/or directly the aspects of quality, safety and efficacy and it does not fall within the definition of minor variation and new registration.

  • Minor Variation-Prior Approval (MiV-PA) & Notification (MiV-N) Variation to a registered pharmaceutical product in terms of administrative data and/or changes with minimal/no significant impact on the aspects of quality, safety and efficacy.

CLICK this LINK to know more about the recent updates to the variation guideline.


Also NPRA released Guidance Notes for Active Pharmaceutical Ingredients (API) Information for Product Registration, CLICK this LINK to know more about the updated information.

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