The National Pharmaceutical Regulatory Agency (NPRA) continues to monitor registered products and notified cosmetics in the local market to ensure the compliance of regulatory requirements in terms of quality, safety, and efficacy.
This summary highlights the key activities and programs undertaken by the Surveillance and Complaints Section (SVA), Centre for Compliance and Quality Control (CCQC), NPRA in 2025, focusing on six primary activities, as below:
1. SAMPLING OF REGISTERED PRODUCTS AND NOTIFIED COSMETICS
Sampling of registered products and notified cosmetics that are available in the local market, is carried out proactively and reactively to monitor compliance. Regulatory oversight in post-marketing surveillance is currently transitioning from conventional sampling toward a more focused, risk-based approach under the Risk-Based Product Quality Monitoring (RB PQM) Programme. Using risk matrix tools, product selection is guided by product characteristics, compliance history, and market signals.
A new approach for sampling registered products which has been initiated in a hybrid manner, namely risk-based sampling (RBS), continued as full RB PQM consist of RBS and risk-based testing (RBT) in 2025. The implementation of the RB PQM approach aims to ensure that the RB PQM Programme remains sustainable, systematic, and effective in optimizing the use of limited resources.
The notified cosmetics were also sampled based on the RBS Sampling method in which cosmetics with a higher risk of containing prohibited substances (e.g. whitening creams, baby-use cosmetics etc.) were prioritized.
In cases involving stock unavailability at the Product Registration Holders (PRHs) or Cosmetic Notification Holders (CNHs) level, the NPRA will conduct random test purchases from the market to obtain the products and cosmetics for sampling and analysis, thereby ensuring continuity and effectiveness of post-market surveillance activities.
In 2025, a total of 2488 samples were collected: 1863 (75%) notified cosmetics and 625 (25%) registered products as shown in Chart 1. Among the 625 registered products were:
I. 309 (13%) products of Prescription or Scheduled Poison (A)
II. 80 (3%) products of Over the Counter – OTC (X)
III. 29 (1%) products of Health Supplement (N)
IV. 207 (8%) products of Natural (T) Category
1.1 Laboratory Testing
A total of 2,188 samples were tested, comprising 654 registered products and 1,534 notified cosmetics. The sample tested for notified cosmetics comprising 646 locally manufactured samples (42.1%) and 888 imported samples (57.9%). A total of 88 samples were found to be out of specification (OOS) or had failed results, comprising 49 registered products and 39 notified cosmetics, as illustrated in Chart 2.
As a consequence of these OOS findings, regulatory actions such as warnings, product recalls, suspension of registration, and cancellation of registration or notification were imposed on the PRHs of the registered products and CNHs of the notified cosmetics.
1.2 Regulatory Action: Recall
One of the regulatory actions is a product/cosmetic recall, which is an action taken by its PRH/CNH, licensed manufacturer, licensed importer, licensed wholesaler to remove or withdraw a particular product/cosmetic from the market or to retrieve the product/cosmetic from any person to whom it has been supplied.
Chart 3 shows the number of registered products and notified cosmetics in the year 2025 that have been recalled with its degrees and levels. A total of 55 products, comprising 30 registered products and 25 notified cosmetics, were instructed to recall from the market. There were 1 (2%) recalls for registered products with Degree I, 10 recalls with Degree II and 19 recalls with Degree III, mainly due to quality defects.
Meanwhile, for notified cosmetics, a total of 25 recalls were conducted, comprising 17 recalls classified as Degree III and 8 recalls involving Degree II accompanied by notification cancellations. These recalls involved cosmetics that tested positive for prohibited substances listed in the Scheduled Poisons List under the Poisons Act 1952.
However, there remains a possibility that consumers may continue using recalled cosmetics. To safeguard public health, the Ministry of Health (MOH), through the National Pharmaceutical Regulatory Agency (NPRA), issues press releases advising the public to immediately discontinue the use of affected cosmetics.
In 2025, the NPRA issued and published a total of six (6) press releases involving 14 cosmetics and one registered product, on NPRA’s official website (www.npra.gov.my). These press releases were also shared with other regulatory authorities through the ASEAN Post-Marketing Alert System (ASEAN PMAS) to facilitate regional information sharing and coordinated regulatory responses among ASEAN Member States.
This approach reflects proactive regulatory engagement and effective dissemination of safety-related information, thereby supporting timely risk mitigation measures and enhancing consumer protection across the ASEAN region.
1.3 Label Review
Label review is another important activity to ensure the information and details on product labels and packaging inserts comply with the stipulated regulatory labelling requirements.
In 2025, a total of 1,118 product labels were reviewed, comprising 581 labels of registered products and 1,623 labels of notified cosmetics, as shown in Chart 4.
Of the registered products reviewed, 114 labels (20%) were found to be non-compliant with established labelling requirements. In such cases, warning letters and label recall were issued to the respective PRHs to ensure corrective actions are taken.
A total of 58 (10%) natural products (category T) were found to have the highest number of non-compliances with labelling requirements (refer to Chart 5). Examples of labelling non-compliances include:
i. Details of the manufacturer and product registration holder (PRH) on the product label is different from the approved label;
ii. Repeated non-compliance with labelling requirements despite the issuance of warning letter;
iii. Product labels that use old labels that have had their registration number revoked;
iv. Failure to include the batch number, manufacturing date and expiry date on the product label;
v. Discrepancies with the information of the active ingredient and the dosage;
vi. Failure to include specific warning statements for certain ingredients;
vii. Use of stick-on labels for some unapproved labelling information and logos;
viii. Discrepancies between the information or graphics on the product label and the approved label.
Meanwhile, for notified cosmetics (Chart 6), a total of 1,074 products were found to be non-compliant with the stipulated labelling requirements. As a result, 1,060 warning letters were issued to the relevant CNHs while 14 cosmetic notifications were cancelled due to non-compliance. These regulatory actions demonstrate consistent measures undertaken to safeguard consumer safety and uphold regulatory integrity. Common examples of labelling non-compliances identified during surveillance activities include:
i. Missing information on the country of manufacture;
ii. Absence of a batch number;
iii. Cosmetic name inconsistent with the name notified;
iv. Labelling information provided only in a foreign language;
v. Missing name and address of the notification holder; and
vi. Inclusion of non-permissible claims on cosmetic labels, such as therapeutic or medicinal claims (e.g. claims to treat, cure, or prevent diseases), or claims that imply pharmaceutical effects beyond the scope of cosmetic use.
These data indicate that there is a higher incidence of non-compliance among notified cosmetics compared to registered products. This may be due to the different regulatory controls between registered products and notified cosmetics, where control over cosmetics is based on notification compared to products which are subject to full registration requirements. Stricter enforcement actions may be required in the future to overcome this problem and raise awareness among the cosmetic industry.
2. HANDLING OF COMPLAINTS ON REGISTERED PRODUCTS AND NOTIFIED COSMETICS
In 2025, the SVA received, investigated, and addressed a total of 1035 complaints and quality reports related to registered products and notified cosmetics. These reports covered various issues such as quality, efficacy, labelling, and packaging, and comprised 888 (86%) cases involving registered products and 147 (14%) concerning notified cosmetics, all handled in accordance with established procedures.
2.1 Quality Reporting of Registered Product
As illustrated in Chart 8, a total of 888 complaints regarding registered products were documented in 2025. A thematic analysis reveals that the majority of complaints were centred on quality (374 cases) and packaging (289 cases) defects, with common issues including empty blisters or fractured tablets and ampoules, representing approximately 74% of the total volume. These were followed by reports on efficacy (132), often linked to brand substitutions, labelling discrepancies (70) frequently involving look-alike sound-alike items or absent labels, and others (e.g. adverse events) (23).
Analysis of procurement categories reveals that reports were largely concentrated within government healthcare supply channels. The Approved Products Purchase List (APPL) accounted for the largest volume, with 404 complaints (45%), followed by Local Purchase (LP) at 201 cases (23%), Tender procurement at 196 cases (22%), and miscellaneous categories such as public complaints and private facility complaints, totalling 87 cases (10%). The higher number of complaints related to APPL-supplied products may be attributed to the increased production capacity required to meet public sector demand, which could potentially impact product quality.
2.2 Quality and Safety Reporting of Notified Cosmetic
As illustrated in Chart 9, the majority of complaints were related to manufacturing issues, accounting for 54 cases (37%), primarily involving manufacturer-related non-compliance. Examples of regulatory complaints included reports claiming that cosmetics were manufactured at facilities that did not comply with Good Manufacturing Practice (GMP) requirements, such as residential premises or shop lots. Other complaints involved declarations from manufacturers confirming that they had not undertaken any manufacturing or packaging activities for the cosmetics concerned.
This was followed by complaints concerning claims, with 42 cases (29%), indicating ongoing issues related to misleading claims and non-compliant cosmetics information. Complaints associated with prohibited substances, including reports of adverse effects and suspected adulteration, accounted for 34 cases (23%), highlighting the importance of continuous monitoring of cosmetic safety.
Meanwhile, quality-related complaints comprised 11 cases (7%), including issues such as packaging defects, as well as reports from healthcare facilities (e.g., hospitals and clinics) concerning cosmetics found to have quality defects, including fungal contamination, black spots, or visible foreign matter.
It should be noted that the use of notified cosmetics for treatment purposes in healthcare facilities is not appropriate. Therefore, it is recommended that the healthcare facilities take measures to ensure that only registered products/medicines are used for treatment or patient care purposes.
A smaller proportion of complaints fell under other categories, with 6 cases (4%), encompassing miscellaneous issues not classified under the main complaint categories, such as parallel import or counterfeit cosmetics.
Overall, the distribution of complaints underscores the need for continued regulatory oversight, particularly in addressing regulatory non-compliance and misleading claims, to protect consumer safety and ensure cosmetic compliance.
3. HANDLING OF REPORTS RELATED TO QUALITY ISSUES FROM PRODUCT REGISTRATION HOLDERS (PRH) AND FOLLOW-UP ON ALERTS/ DIRECTIVES
Maintaining the quality, safety, and efficacy of pharmaceutical products is paramount to protecting public health. This subtopic outlines the key activities carried out by the SVA in 2025 related to the handling of quality issue reports submitted by Product Registration Holders (PRHs) and the subsequent follow-up on alerts and directives.
A comprehensive analysis of these reports reveals key trends in product quality incidents within Malaysia, highlighting the prevalence of Out-of-Specification (OOS) incidents, voluntary recalls, and responses to specific regulatory directives and emerging impurity concerns. This overview provides valuable insights into the challenges and efforts involved in ensuring that registered products meet the quality standards.
As illustrated in Chart 10, Out-of-Specification and Impurity reports accounted for 33 cases (53%), while voluntary recall (VR) reports comprised the remaining 29 cases (47%). Together, these two categories represent a total of 62 handled reports related to quality issues and follow-up actions in 2025.
Out-of-Specification (OOS) reports predominantly originated from stability study deviations, specifically concerning dissolution parameters, assay precision, and related substances, including nitrosamine impurity thresholds. To mitigate identified risks, Product Registration Holders (PRHs) executed proactive voluntary recalls of the affected pharmaceutical batches, ensuring continued compliance with safety standards and market integrity.
4. HANDLING OF ASEAN POST MARKETING ALERT SYSTEM (PMAS) AND RAPID ALERTS
This section provides a summary of the SVA involvement in managing International Regulatory Alerts via ASEAN Post Marketing Alert System (PMAS) and Rapid Alerts during 2025, of both products and cosmetics.
The handling of a product/cosmetic alert is a critical process undertaken by regulatory authorities to protect consumer safety and ensure regulatory compliance. The process involves timely detection, assessment, communication, and follow-up actions to address potentially harmful or non-compliant products/cosmetics in the market.
These international alert mechanisms strengthen national surveillance systems and help prevent public exposure to unsafe products/cosmetics, especially in cases where products/cosmetics are traded across borders or available online.
4.1 Handling of Product Alert
The data presented in Chart 11 illustrates the number of Rapid Alerts received and reviewed by the SVA in 2025, totalling 550 alerts involving 2795 products.
However, only 2 Rapid Alerts were issued by the NPRA, all of which involved 2 registered products. These alerts were disseminated to inform stakeholders and regulatory counterparts of significant safety concerns requiring immediate attention.
The infographic above illustrates the number of ASEAN Alerts related to products that were received, reviewed, and issued by the SVA in 2025. A total of 32 ASEAN Alerts were issued by the SVA, involving 38 registered products.
Meanwhile, the SVA received and reviewed 214 alerts from other ASEAN member countries, involving a total of 354 products.
4.2 Handling of Cosmetics Alert
Chart 13 above presents the number of ASEAN PMAS and Rapid Alerts related to cosmetics that were received and reviewed by the SVA in 2025. 17 alerts were received comprising 16 ASEAN PMAS alerts (94.1%) and 1 Rapid Alert (5.9%). These alerts involved 60 cosmetics (96.8%) under ASEAN PMAS and 2 cosmetics (3.2%) from Canada under the Rapid Alert mechanism. Of the cosmetics received through ASEAN PMAS, 11 cosmetics (17.7%) were notified cosmetics in Malaysia, while none of the cosmetics received through Rapid Alerts were notified cosmetics.