Malaysia Regulatory News

On 9 December 2022 the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published revised cosmetics control regulations, including new product categories and labelling requirements. The Control of Drugs and Cosmetic Regulations (CDCR) 1984 rules have outlined some standards that the companies who produce, market, sell, import, or keep the products are required to adhere to all those standards.

The following amendments are included in the update:    

• Three new cosmetics product categories have been added: hand sanitisers, sunscreen products, as well as essential oil for skin, hair, and nails.
• Before products may be marketed in Malaysia, they must be labelled in accordance with the regulations. Products in the vials or ampoules must be labelled "for external use only."
• A Halal logo may be used on a notified cosmetic product, but it must be approved by the Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM), or any Islamic entity recognised by JAKIM.
• In addition, the list of approved components for UV filters, preservatives, and colouring agents has been eliminated.
• The guidelines for Good Manufacturing Practise (GMP) have also been amended. New regional producers and manufacturing lines will now be inspected by the NPRA before being notified under the CDCR.
• The production facility's layout must be established and constructed in accordance with GMP guidelines.
• Manufacturers from other countries will need documentation of GMP compliance from an authorised body.
• Requirements for claims, product recalls and complaints are now included in the updated guidelines.