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Malaysia is improving efficiency in both pre-marketing product assessment and post-approval changes. Consequently, on May 31, 2024, Malaysia announced new timelines for variation applications of registered pharmaceutical products, natural product, and health supplement products. However, a pilot study will be conducted for one year before finalizing the new timelines. Therefore, starting from June 1, 2024, product registration holders are advised to follow the new timeline for submission.
The revised variation timelines for natural and health supplement products are as follows:
Variation type | Timeline |
MiV-N
| 10 working days (maximum of 5*) |
MiV-PA
| 70 working days (maximum of 5*) |
MaV
| 100 working days (maximum of 3*)
|
Grouping (bundle applications) | 120 working days (maximum of 5 variation applications including a maximum of 3 MaV applications*)
|
*Please note that the National Pharmaceutical Regulatory Agency (NPRA) will not reject variation applications that exceed the maximum number of permitted variation types per registered product. However, the timelines may be extended beyond the new timelines.
For more details and FAQs, please refer to the official notice. Explanations about different variation types can be found in the "Malaysian Variation Guideline for Natural and Health Supplement Products."
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