Malaysia Advances Digital Transformation of Healthcare Product Labeling

Malaysia is accelerating the digital transformation of healthcare product labeling through new regulatory updates affecting both pharmaceutical and medical device manufacturers.

On May 13, 2026, the National Pharmaceutical Regulatory Agency (NPRA) published updated FAQs and a circular on electronic labeling, following a Ministry of Health circular issued the previous day. Separately, on May 22, 2026, the Medical Device Authority (MDA) revised foreign manufacturer contact detail requirements within its medical device labeling guidance.

Together, these updates signal Malaysia’s continued move toward digital regulatory communication while clarifying key labeling requirements for companies supplying healthcare products to the market.

NPRA Discontinues Printed DHCP Letter Distribution

The NPRA circular confirms that the Drug Control Authority (DCA), during its 420th meeting on May 7, 2026, approved the discontinuation of printed “Dear Healthcare Provider” (DHCP) letters accompanied by Package Inserts (PI) and/or Consumer Medication Information Leaflets (RiMUP - Risalah Maklumat Ubat untuk Pengguna) for products implementing e-labeling.

The decision applies during the current voluntary implementation period, which began on May 1, 2023. According to NPRA, no requests for printed PI or RiMUP copies have been received from healthcare professionals or healthcare facilities since the program was introduced, supporting the shift toward digital access.

Printed PI and RiMUP Copies Must Still Be Available on Request

Although routine distribution of printed materials is no longer required, product registration holders (PRHs) remain responsible for providing printed PI and/or RiMUP copies when requested by healthcare professionals or healthcare facilities.

DHCP letters may now be distributed electronically, reducing administrative burden while preserving access to printed information when needed.

Pharmaceutical e-Labeling Continues Through the Voluntary Phase

Malaysia’s pharmaceutical e-labeling framework remains in its voluntary phase through December 31, 2026.

The system allows approved product information to be accessed through QR codes on product packaging, directing users to the latest approved records within the QUEST3+ platform.

Available information may include:

• Product name and registration number
• Product registration holder details
• Manufacturer and importer information
• Active ingredients
• Packaging and label information
• Package Inserts (PI)
• Consumer Medication Information Leaflets (RiMUP)

By linking users directly to approved regulatory records, the framework helps ensure access to current product information without relying solely on printed documentation.

OTC Products Are Included from August 2026

The scope of pharmaceutical e-labeling covers registered pharmaceutical products for human use, including biologics, new drug products, and generic products containing scheduled poisons. The DCA approved this initial scope at its 383rd meeting in April 2023.

Beginning August 1, 2026, the scope will expand to include generic products containing non-scheduled poisons, commonly referred to as over-the-counter (OTC) medicines, following approval by the DCA at its 410th meeting on July 3, 2025.

For manufacturers supplying OTC products to Malaysia, the expansion may require updates to packaging and labeling strategies to support digital access to approved product information.

PRHs Use QUEST3+ for e-Labeling Submissions

Companies seeking to implement electronic labeling for existing products must submit a variation application under the “Minor Variation Notification (MiV-N): E-Labelling Verification” category through QUEST3+.

For new registrations, applications may be submitted as part of the product dossier.

NPRA recommends completing the necessary submission immediately after DCA approval — or before product launch at the latest — to ensure packaging links to the most current approved information.

During the voluntary phase, QUEST3+ remains the designated platform for hosting approved electronic labeling content.

MDA Revises Medical Device Foreign Manufacturer Labeling Requirements

Alongside the pharmaceutical updates, the MDA revised its guidance document, “Requirements for Labelling of Medical Devices”, on May 22, 2026.

The change affects Section 4.8(e), which outlines labeling requirements for foreign manufacturers. Under the revised guidance, foreign manufacturers must provide:

• Manufacturer name
• Manufacturer address

Contact details for technical assistance, such as email address, telephone number, and/or website address, are optional.

The revision simplifies labeling requirements while maintaining the essential information needed for product identification.

Regulatory Considerations for Foreign Manufacturers and PRHs

As Malaysia advances its digital labeling framework and refines healthcare product labeling requirements, companies should assess the broader compliance implications beyond the immediate regulatory changes.

Pharmaceutical e-Labelling Governance

Companies implementing e-labeling should ensure alignment between approved product information, QR code functionality, packaging artwork, and records maintained within QUEST3+. Robust change-control processes can help prevent inconsistencies between physical packaging and electronically accessible regulatory information.

Preparation for OTC Scope Expansion

With OTC medicines entering the e-labeling framework from August 2026, manufacturers may wish to evaluate whether existing packaging, artwork, and regulatory workflows can efficiently support implementation across larger product portfolios.

Medical Device Labeling Reviews

Foreign manufacturers should review current labeling formats against the revised MDA requirements and determine whether existing global label templates remain appropriate for products supplied to Malaysia. The updated guidance may provide opportunities to simplify locally applied labeling content while maintaining compliance.

Cross-Functional Alignment

As regulatory information becomes increasingly accessible through digital channels, coordination between regulatory affairs, labeling, packaging, and quality functions becomes increasingly important to ensure that approved information remains accurate, current, and consistently presented across all platforms.

Looking Ahead: Malaysia's Evolving Labeling Framework

The latest NPRA and MDA updates underscore Malaysia’s focus on improving access to approved product information while streamlining administrative requirements. They also demonstrate regulators’ willingness to adapt established labeling practices in response to digital adoption and real-world experience.

For pharmaceutical companies, the expansion of e-labeling reinforces the growing importance of digital regulatory information in product lifecycle management. For medical device manufacturers, the revised MDA guidance emphasizes proportionate, fit-for-purpose labeling requirements.

With the voluntary phase for pharmaceutical e-labeling running through December 2026, companies should monitor NPRA communications closely. A study currently being conducted in collaboration with University Teknologi MARA (UiTM) will assess the effectiveness of the initiative and help inform whether the framework transitions to mandatory implementation beyond that date.

Beyond reducing paper-based requirements, the Malaysian framework reflects a broader shift toward regulator-hosted digital product information. Companies should consider how e-labeling may affect global labeling governance, artwork management, change control, and lifecycle maintenance processes as digital product information becomes increasingly integrated into regulatory oversight.

As these frameworks evolve, aligning product information, labeling, packaging, and regulatory records becomes increasingly complex, making local regulatory expertise essential.

With a presence in Penang, Malaysia, and extensive Asia-Pacific experience, Cisema helps companies reduce compliance risk and ensure consistency across both digital and physical labeling throughout the product lifecycle.

For foreign manufacturers and product registration holders seeking guidance on regulatory alignment or digital labeling strategies, contact Cisema today.

Further Information

• Discover Cisema Medical device services in Malaysia 
• Explore Cisema’s Pharmaceutical consulting services

References ‍

• Revision to the Requirements for Foreign Manufacturer Contact Details in the Guidance Document: Requirements for Labelling of Medical Devices‍
• Frequently Asked Questions (FAQ) on E-Labelling‍
• Circular on the Discontinuation of Printed Dear Healthcare Provider (DHCP) Letters and Printed Copies of Package Inserts (PI) and/or Consumer Medication Information Leaflets (RiMUP) for the Implementation of Electronic Labelling (E-Labelling) for Pharmaceutical Products

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