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 key activities and programs undertaken by the Surveillance and Complaints Section (SVA), Centre for Compliance and Quality Control (CCQC), NPRA in 2024, focusing on five primary activities, as below:
1. SAMPLING OF REGISTERED PRODUCTS AND NOTIFIED COSMETICS
Sampling of registered products and notified cosmetics that available in the local market, is carried out proactively and reactively to monitor compliance. A hybrid Risk-Based Sampling (RBS) method was implemented to optimize resources and improve systematic monitoring. 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) were prioritized.
In 2024, a total of 2,747 samples were collected: 2007 (73%) notified cosmetics and 740 (27%) registered products as shown in Chart 1. Among the 740 registered products were:
i. 190 products of Prescription or Scheduled Poison (A)
ii. 36 products of Over the Counter – OTC (X)
iii. 36 products of Health Supplement (N)
iv. 478 products of Natural (T) Category
1.1 Laboratory Testing
A total of 2,915 samples were tested, comprising 1,338 registered products and 1,577 notified cosmetics. A total of 86 samples were found to be out of specification (OOS) or had failed results, comprising 47 registered products (3.5%) and 39 notified cosmetics (2.5%), 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 Product Registration Holders (PRHs) of the registered products and Cosmetic Notification Holders (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 year 2024 that have been recalled with its degrees and levels. A total of 42 products, comprising of 20 registered products and 22 notified cosmetics, were instructed to recall from the market. There were 6 (30%) recalls for registered products with Degree II Level B and 14 (70%) recalls with Degree III Level B, mainly due to quality defect. There was no recall involving Degree I or Levels A and C.
Meanwhile, for notified cosmetics, a total of 22 recalls were conducted, comprising 14 recalls (64%) classified as Degree III, Level B, and 8 recalls (36%) classified as Degree II, Level B. 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.
These alerts are published on the NPRA’s official website (www.npra.gov.my). They are also shared with other regulatory authorities via the ASEAN Post-Marketing Alert System (ASEAN PMAS) to ensure regional information sharing and coordinated regulatory response across ASEAN member states.
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 2024, a total of 2,813 product labels were reviewed, comprising 870 labels of registered products and 1,943 labels of notified cosmetics, as shown in Chart 4.
Of the registered products reviewed, 253 labels (29%) were found to be non-compliant with established labelling requirements. In such cases, warning letters were issued to the respective PRHs to ensure corrective actions are taken.
A total of 202 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. Discrepancies between the information or graphics on the product label and the approved label,
ii. Absence of a batch number, and
iii. Failure to include specific warning statements for certain ingredients.
Meanwhile, for notified cosmetics (refer to Chart 6), a total of 1,510 products (80%) were found to be non-compliant with the stipulated labelling requirements. As a result, warning letters were issued to the relevant CNHs. Examples of labelling non-compliances include:
i. Missing information on the country of manufacture,
ii. Absence of a batch number,
iii. Cosmetic name inconsistent with the name notified,
iv. Label information provided only in a foreign language, and
v. Missing name and address of the notification holder.
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 2024, the SVA received, investigated, and addressed a total of 1,112 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 944 cases involving registered products and 168 concerning notified cosmetics, all handled in accordance with established procedures.
2.1 Quality Reporting of Registered Product
The infographic in Chart 8 below illustrates the breakdown of complaints received for registered products by procurement category, namely: Approved Products Purchase List (APPL) – 397 complaints (42%), Local Purchase (LP) – 241 complaints (25%), Tender – 204 complaints (22%), and Others – 102 complaints (11%).
The majority of complaints originated from Ministry of Health (MOH) facilities, as purchases through the APPL primarily involve government healthcare institutions. 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 Complaints of Notified Cosmetic
In 2024, a significant portion of complaints concerning notified cosmetics were related to adverse side effects reported by consumers and suspected presence of prohibited substances, including mercury, hydroquinone, and tretinoin. These complaints were typically submitted by users who experienced skin reactions or had concerns about cosmetic safety and ingredient transparency.
As illustrated in Chart 9, these issues highlight the ongoing need for post-market surveillance and enforcement to ensure that cosmetics sold in the market comply with safety and regulatory requirements.
Complaints involving exaggerated or misleading claims on cosmetic labels, such as making medical claims or claims beyond the scope of cosmetics, represented the second highest category of complaints, totalling 66 cases (39%). This was followed by regulatory related complaints at 12 cases (7%), and other miscellaneous complaints at 9 cases (5%).
An example of a regulatory complaint includes a report alleging that a cosmetic was manufactured at a facility lacking Good Manufacturing Practice (GMP) certification, with additional concerns such as fungal contamination, black spots, or visible dirt on the cosmetics.
The highest number of complaints involved the presence of prohibited substances, reflecting a heightened level of consumer awareness regarding cosmetic safety. This awareness is likely reinforced by regular public updates and press releases issued by the Ministry of Health (MOH) through the National Pharmaceutical Regulatory Agency (NPRA) concerning the detection of banned substances in notified cosmetics.
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 2024 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, the highest number of reports received were Out-of-Specification (OOS) incident reports, accounting for 70 cases (55%). Of these, 65 reports involved imported products, while 5 involved locally manufactured products.
The second highest category was voluntary recall reports, with a total of 28 cases (22%), submitted by PRHs. These included 23 local products and 5 imported products.
In addition, 16 recall reports (13%) were submitted in response to a regulatory directive issued on 19 November 2024, which prohibited the use of chloroform/chloroform spirit as a preservative in pharmaceutical products, natural products, and health supplements.
Lastly, reports related to nitrosamine impurities comprised 11 cases (9%) of the total reports received, reflecting the ongoing efforts to monitor and address potential carcinogenic contaminants in pharmaceutical products.
In addition, reports concerning Diethylene Glycol (DEG) and Ethylene Glycol (EG) impurities, as well as follow-up reports related to PIC/S Alerts, accounted for approximately 2% of the total quality reports handled in 2024. Specifically, one report was received regarding a local product suspected of containing DEG/EG in the overseas market. However, following a thorough investigation and sample testing conducted by the NPRA and overseas laboratories, it was confirmed that the product did not contain DEG or EG.
As for PIC/S Alert follow-up reports, two reports were received. The low number was attributed to the fact that most PIC/S Alerts issued during the year did not involve products registered in Malaysia.
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 2024, 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 2024, totalling 346 alerts involving 460 products.
However, only 6 Rapid Alerts were issued by the NPRA, all of which involved 6 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 2024. A total of 24 ASEAN Alerts were issued by the SVA, involving 55 registered products.
Meanwhile, the SVA received and reviewed 107 alerts from other ASEAN member countries, involving a total of 165 products. These efforts reflect active regional collaboration and information sharing under the ASEAN Post-Marketing Alert System (PMAS) to enhance regulatory vigilance and protect public health across the region.
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 2024. In total, 17 alerts involving 240 cosmetics were received and assessed. Of these, 4 cosmetics were found to be notified in Malaysia, prompting further regulatory review and action where necessary.
On the other hand, 7 ASEAN Post-Marketing Alerts (PMAS) were issued by the SVA to other ASEAN Member States last year, involving 19 cosmetics found to contain prohibited substances. As shown in Chart 14, mercury was the most frequently reported substance (30%), followed by tretinoin, hydroquinone, betamethasone 17-valerate, clindamycin, and metronidazole. Notably, some cosmetics were found to contain more than one prohibited substance.
5. MONITORING OF COSMETIC ADVERTISEMENTS AND HANDLING OF COMPLAINT REPORTS ON NOTIFIED COSMETIC ADVERTISEMENTS
5.1 Proactive Monitoring of Cosmetic Advertisements
Advertising of notified cosmetics is regulated by the SVA, NPRA in accordance with the Guideline for Cosmetic Advertisement, which is outlined in Annex 1, Part 10 of the Guidelines for Control of Cosmetic Products in Malaysia.
In 2024, a total of 1,226 notified cosmetics advertisements were screened across various platforms, including social media (Facebook, TikTok, Instagram, YouTube, X) and e-commerce sites (Shopee, Lazada, Temu).
The results of advertisement monitoring (refer to Chart 15) revealed that 842 advertisements (68%) were compliant, while 384 (31%) were non-compliant. Among the non-compliant cases as below:
i. 291 cosmetics (76%) had their notification status cancelled due to prohibited medical claims, such as treatment for asthma, eczema, scabies, joint pain, body slimming, and sexual enhancement,
ii. 89 cases (23%) resulted in advertisement warning letters issued to CNHs for making claims not aligned with cosmetic guidelines,
iii. 4 cases (1%) were categorized under other types of non-compliance.
5.2 Handling of Complaint of Notified Cosmetic Advertisements
In addition to proactive monitoring, the SVA also handle complaint reports related to advertisements of notified cosmetics that may breach regulatory guidelines. These complaints typically involve issues such as misleading or exaggerated claims, medical claims and non-compliance with stipulated requirements.
Upon receiving a complaint, thorough investigations are conducted in accordance with the procedure. Where non-compliance is confirmed, appropriate regulatory actions are taken, which may include:
i. Issuance of warning letters to CNHs,
ii. Request for immediate removal or correction of non-compliant advertisements,
iii. Cancellation of cosmetic notification status for serious violations.
This complaint-based enforcement complements routine advertisement surveillance, ensuring that cosmetic promotions remain within the permitted scope defined for cosmetic and do not mislead consumers.
In 2024, SVA received and investigated a total of 101 complaints related to notified cosmetic advertisements. Of these, 75 complaints were lodged by private companies, 24 by members of the public, and 2 from other sources, as illustrated in Chart 16.
Investigations confirmed that all complaints were valid, and appropriate regulatory actions were taken against the respective CNHs. These actions included notification cancellations (32 cases) and issuance of warning letters (32 cases), as summarised in Chart 17.
In several cases, CNHs were required to submit supporting data for advertisements that included suspicious or exaggerated claims, such as “fading acne scars” or “skin whitening in 5 minutes”, which may fall outside the permitted scope for cosmetic.
Prepared by:
Team SVA
July 2025