Editor's notes: This article was originally published on April 10, 2024 and was updated on April 15, 2024 as per the latest developments. The updated contents are marked in red below.
Malaysia has approved the registration of natural products with modern claims, effective from April 4, 2024. The registration will be implemented following the Guideline on Natural Products with Modern Claim.
In Malaysia, products like health supplements and natural products are supervised as medicinal products. Before April 4, 2024, natural products were only allowed to bear traditional claims (e.g., relieving mild symptoms) and therapeutic claims (e.g., helping with the treatment of a disease).
Chart 1: Classification of Medicinal Products in Malaysia
Source: Drug Registration Guidance Document (DRGD)
However, as explained by the National Pharmaceutical Regulatory Agency (NPRA) of the MOH, with the evolvement of traditional medicines especially herbal ingredients manufactured through using modern technologies, newer scientific evidences showing different medicinal properties than traditional use have been discovered. However, based on the previous requirements, such products can only be registered under the traditional product category because they do not have enough evidence from clinical studies to have therapeutic claims. Therefore, there is a need to approve another category of intermediate natural products with modern demands.
Now, in the official announcement on April 6, 2024, Malaysia has granted approval for the registration of natural products with modern claims. Modern claim is the claim supported by scientific evidence, aiming to improve health, reduce the risk of disease, or aid in the management of a disease. Scientific studies verifying these modern claims must have a link between the product formulation and its health effects. This regulatory change represents a comprehensive step towards strengthening Malaysia's oversight of natural products and is expected to stimulate industry growth.
On April 15, 2024, the NPRA issued the full text of this Guidance, which details the application scope, definition of modern claim, and registration requirements. For details, please click here.
