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Malaysia announces revised timelines for variations of registered health supplements application

Malaysia

Jun 14, 2024

On May 31, 2024, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia announced revisions to the timelines for variation applications of registered pharmaceutical products and natural health supplements (TMHS). The new guidelines, aiming to enhance efficiency in post-approval changes, will be tested in a one-year pilot study starting June 1, 2024. The revised timelines vary from 10 to 150 working days depending on the type of product and variation. NPRA encourages product registration holders to plan accordingly, though applications exceeding the permitted variations won't be rejected but may face extended review periods.

For further information (in English), click on the Link

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