National Pharmaceutical Regulatory Agency (NPRA) is the regulatory body under Ministry Of Health, Malaysia that is responsible to ensure health product which include pharmaceuticals, traditional medicine, health supplements and cosmetics fulfill the quality, safety and efficacy requirements before it could be marketed in Malaysia. This regulatory control is conducted through registration of product, product testing, licensing and surveillance.
Once a product is registered or notified (for cosmetics), NPRA continuously monitored these products in the market, through its Post Market Surveillance activities.
The main objective of the Post Market Surveillance activity are to monitor the quality of registered or notified products in the Malaysian market and to ensure compliances towards standards/specification set by the Ministry of Health, Malaysia. Through this monitoring programme, unsafe products shall be removed from the market hence protecting the consumer indirectly.
A unique registration number will be assign to each registered product/ notification for cosmetic.
Sampling of registered/ notified products is conducted either by scheduled sampling or risk approach for example through complaint received, track records of non-compliances towards criteria set, manufacturer who does not comply to Good Manufacturing Practice, monitoring of promotional material from the media or referring to reports from international regulatory bodies.
Label and Package Insert Checking
The next sampled products will be reviewed for packaging including labels and / or packing inserts. This review will be based on the latest labeling requirements set by NPRA as well as the product information contained in the registration record.
Packaging of the sampled product which include label and/ or package insert will then be check. Package checking will be conducted according to the latest requirement set by NPRA and also by referring to product registration record information. (Latest requirement of Drug Registration Guidance Document could be downloaded from web address:www.npra.gov.my under ‘News & Publication’.
Sampled product will then be tested by NPRA laboratory which is accredited ISO17025 since 2010. Among tests run in the lab includes adulteration screening, disintegration, heavy metal and microbial limit test for traditional products.
Pharmaceutical and health supplement on the other hand will be qualitative and quantitatively tested such as active ingredient, dissolution, weight/ content uniformity and the test will be conducted according to company’s protocol and pharmacopeia main reference.
Whereas for notified cosmetic, in addition to heavy metal and microbial limit test, adulteration test is conducted on suspicious cosmetics for example cosmetics with whitening and treatment claims.
Product Complaint Reporting
Besides proactive surveillance, NPRA also handles complaints from public on registered and notified product. Every single complaint received will be investigated and complainant will be informed on investigation result. Complaints received include complaint on quality of product, packaging, labelling that does not comply with requirements, efficacy of product, and suspicious adulterated product.
Complaint could be reported to NPRA by using Form 418.4 (health professional use) and Form 419 (consumer use) which could be downloaded from NPRA website as follows:
For health professional:
Regulatory Action against Registered Product/ Cosmetic
Action will be taken against products that were found non-compliance to requirements of labeling, quality and/ or safety. Actions include issuance of warning letter and/ or recall instruction to the product registration company. A detail report from the company on the reason of nonconformities and corrective & preventive action taken must be submitted to NPCB according to the date line given. NPRA will monitor the actions taken by the company to prevent further repetition of such offence.
In situation whereby a product is detected to be adulterated with prohibited substances, cancelation of registration/ notification could be taken and the company’s license could be withdrawn. Cancelation of product registration/ notification will be announced through media and also through NPRA website.
Responsible of All Parties
Product registration holder is responsible to ensure their product in the market complies with the registration requirements whether from the labelling, quality, safety aspects and/ or effectiveness. It is their responsibility to report to NPRA any issue which will affect the quality, efficacy and safety of the marketed product.
NPRA on the other hand through surveillance activity ensure that registered/ notified products in Malaysia always comply to the requirement set hence indirectly protect consumer from consuming substandard and harmful products.
Nevertheless, consumer as the biggest group in this chain should be alert and sensitive towards products they are using. Consumer could file an inquiries or complaint on registered/ notified products if any to NPRA. Besides that, consumer is also encouraged to report any adverse event cause by usage of product in the market.
|Last Reviewed||:||05 November 2014|
|Writer/Translator||:||Ahmad Huzaifi bin Ezani|
|Accreditor||:||Nurhayati bt. Othman|