|Control of Drugs and Cosmetics Regulations 1984|
|National Pharmaceutical Regulatory Agency (NPRA)|
|Main Supporting Rules|
|Feb 2017||Guidelines for Control of Cosmetic Products in Malaysia(2017)|
From year 2002 to the end of year 2007, the control of cosmetic products was conducted through pre-market registration; where the company which is responsible for placing the product in the local market submit product details and relevant certificates for review and registration before the product can be manufactured, imported or sold in the country.
As a member state of ASEAN Malaysia agreed to replace the system with a notification procedure starting from 1 January 2008 in conformance with the harmonization of cosmetic regulations in the ASEAN region. Instead of registration, companies are now required to only notify/declare their compliance status to the Director of Pharmaceutical Services (known as DPS) through National Pharmaceutical Regulatory Agency (NPRA). Regulatory action will be taken in the event of false declaration and/or product found to be non- compliant to the stipulated regulations and guidelines.
|Guidelines for Control of Cosmetic Products in Malaysia(2017)||Reference for notification process including quality control, inspection and post-market surveillance activities of cosmetics|
|Guidence how to organize and compile the PIF based on a recommended PIF format|
Help the Cosmetic Industry in assessing the safety of the product as well as the Regulators in auditing the data contained in the Product Information File (PIF)
Guidance to the cosmetic industry in developing advertising message in ethical manner and to ensure responsible advertising by the advertiser
Guidance for the labelling requirements of cosmetic products
Provides a simple 5-step decision-making process that helps to identify products and claims which can be considered to be cosmetics
Offer assistance to the cosmetic industry in compliance with the requirements for Cosmetic GMP
Director of Pharmaceutical Services (DPS) is the authority responsible for the regulation of cosmetics products.
National Pharmaceutical Regulatory Agency (NPRA) acts as a secretariat to the DPS which is in charge of the cosmetic notification process and the post-market surveillance.
The definition of cosmetics is based on the ACD. A cosmetic product shall mean “any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”. (click here to see the illustrative list of cosmetic product by categories).
All cosmetic products must be manufactured in accordance to the Guidelines for Cosmetic Good Manufacturing Practice or its equivalent. For details, please refer to Guideline for Cosmetic Good Manufacturing Practice and List of Equivalent Cosmetic GMP Guidelines. Local manufacturer is subjected to periodical inspection by GMP auditors from the NPRA to ensure continuous compliance. For foreign manufacturer, documentation to prove GMP compliance is to be made available upon request by the NPRA.