Date: 19-Oct-2026
Agency: NPRA Malaysia
Intelligence Overview
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has issued Directive No. 20 of 2026 requiring the package inserts and Consumer Medication Information Leaflets (RiMUP) of all atorvastatin-containing products to be updated with safety information regarding the risk of photosensitivity reactions. 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).
The directive aims to strengthen safety information for atorvastatin, a statin medication used to manage cholesterol levels and reduce cardiovascular risk. The updated labeling will communicate the potential for abnormal skin reactions associated with exposure to sunlight or ultraviolet (UV) radiation.
Key Labeling Updates
1. Package Insert
The Adverse Effects/Undesirable Effects – Post-marketing Experience section must include the following information:
- Skin and subcutaneous tissue disorders: Photosensitivity reaction and photodermatosis.
2. Consumer Medication Information Leaflet (RiMUP)
The Side Effects section must include the following information:
- Side effects reported during post-marketing experience: Abnormal skin reactions to sunlight or UV rays.
Implementation Timeline
NPRA has established the following deadlines for implementation:
| Product category | Implementation requirement |
|---|---|
| New applications | Immediately |
| Products currently undergoing registration evaluation | 1 November 2026 |
| Already registered products | Submit a MiV PA2 variation application for product labeling changes before 1 May 2027 |
Regulatory Impact
This directive highlights the importance of post-marketing safety surveillance and timely updates to product information in response to emerging safety concerns.
Marketing Authorization Holders (MAHs) of atorvastatin-containing products in Malaysia should review the directive, update the relevant package inserts and RiMUP documents, and plan the necessary regulatory variation submissions within the specified timelines.
Regulatory affairs and pharmacovigilance teams should coordinate to ensure that the revised safety information is accurately reflected in product labeling and communicated appropriately to healthcare professionals and patients.
Source: https://www.npra.gov.my/easyarticles/images/users/1153/DCA/Direktif/2026/Direktif_Atorvastatin_Pengemaskinian-sisip-bungkusan-dan-RiMUP-risiko-reaksi-fotosensitivit_20261020-09Octth_1.pdf https://www.npra.gov.my/index.php/en/component/content/article/225-english/1527890-direktif-untuk-semua-produk-yang-mengandungi-atorvastatin-pengemaskinian-sisip-bungkusan-dan-rimup-dengan-maklumat-keselamatan-berkaitan-risiko-reaksi-fotosensitiviti-photosensitivity-reaction.html?Itemid=1391