Date: 19-Oct-2026
Agency: NPRA Malaysia
Intelligence Overview
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has issued Directive No. 21 of 2026 requiring updates to the package inserts and Consumer Medication Information Leaflets (RiMUP) for all products containing non-vitamin K antagonist oral anticoagulants (NOACs). The directive addresses the safety risk of anticoagulant-related nephropathy (ARN).
The directive was issued under Regulation 29 of the Control of Drugs and Cosmetics Regulations 1984, following a decision by the Drug Control Authority (DCA) on 8 October 2026. It aims to strengthen safety information for NOAC-containing products by ensuring that relevant kidney-related adverse reactions are appropriately reflected in product labeling.
The directive applies to products containing the following active ingredients:
- Dabigatran
- Rivaroxaban
- Apixaban
- Edoxaban
Key Labeling Updates
1. Package Insert Updates
Marketing Authorization Holders (MAHs) are required to update the relevant safety sections of product package inserts to include information on anticoagulant-related nephropathy.
The specified sections vary by active ingredient and include Adverse Effects/Undesirable Effects, Renal and urinary disorders, or Bleeding, as applicable.
2. Consumer Medication Information Leaflet (RiMUP) Updates
The Side Effects section of the RiMUP must be revised to communicate the risk in consumer-friendly language.
The updated information describes bleeding in the kidneys, which may be associated with blood in the urine and impaired kidney function. The directive indicates that the frequency of this adverse reaction cannot be estimated from the available data for the relevant products.
Regulatory Impact
This directive highlights the importance of ongoing pharmacovigilance and the timely incorporation of emerging safety information into approved product labeling.
MAHs responsible for NOAC-containing products in Malaysia should review the directive and its ingredient-specific requirements, coordinate updates to package inserts and RiMUP documents, and ensure compliance with the applicable NPRA procedures.
Regulatory affairs and pharmacovigilance teams should work together to assess the impact on affected product information and maintain consistency between professional labeling and patient-facing safety communications.
Source: https://www.npra.gov.my/easyarticles/images/users/1153/DCA/Direktif/2026/Direktif_NOACsPengemaskinian-sisip-bungkusan-dan-RiMUP-risiko-anticoagulant-related-nephropathy-ARN.pdf https://www.npra.gov.my/index.php/en/directive-general/1527891-direktif-untuk-semua-produk-yang-mengandungi-non-vitamin-k-antagonist-oral-anticoagulants-noacs-dabigatran-rivaroxaban-apixaban-dan-edoxaban-pengemaskinian-sisip-bungkusan-dan-rimup-dengan-maklumat-keselamatan-berkaitan-risiko-anticoagulant-related-nephropathy-arn.html