The Drug Control Authority (“DCA”) is the executive body established under the Control of Drugs and Cosmetics Regulations 1984 (“CDCR 1984”), to ensure the safety, quality and efficacy of pharmaceuticals, health and personal care products that are marketed in Malaysia.
The DCA is responsible for the registration of all pharmaceutical and cosmetics products, licensing of premises for importer, manufacturer and wholesaler, monitoring the quality of registered products in the market and Adverse Drug Reaction Monitoring.
The National Pharmaceutical Regulatory Agency (“NPRA”), formerly known as the National Pharmaceutical Control Bureau, which is a secretariat of DCA, was established to implement quality control on pharmaceutical products.
The NPRA is also responsible for ensuring the quality, efficacy and safety of pharmaceuticals through the registration and licensing scheme.
Product Registration for Pharmaceutical Products
Regulation 7(1)(a) of the CDCR 1984 provides that all products need to be registered with the DCA prior to being imported, manufactured, sold or supplied, unless the product is exempted under specific provision of the CDCR 1984.
Product is defined as “(a) a drug in a dosage unit or otherwise, for use wholly or mainly by being administered to one or more human beings or animals for a medical purpose or (b) a drug to be used as an ingredient of a preparation for a medicinal purpose”.
A registered drug is a drug that has been evaluated, tested and approved by the DCA for the sale and use in Malaysia. Every registered drug is given a registration number that must be printed on its label or package.
The drugs that are required to be registered are pharmaceutical products containing scheduled poisons, pharmaceutical products containing non-scheduled poisons, traditional products and veterinary products.
Product registration can only be done via online submission through NPRA’s website.
For first time users, the applicant must register for an access to Quest3+ online system (a system created by NPRA for the purpose of pharmaceutical and cosmetic product registration) before the applicant can proceed with the product registration.
Once the account has been created, the applicant will receive a username and password from NPRA via email, subsequently the applicant will be able to access the registration website and proceed with the online submission.
The processing fee for the product registration is as follows:-
The DCA will charge any costs as it may incur for the purpose of carrying out laboratory investigation/testing prior to the registration of any product. Applications without the prescribed fees will not be accepted and such processing fee is not refundable. The duration required for the product registration is calculated from the date of final and complete submission. The timeline for the product registration of each category is as follows:
A product will only be registered if it satisfies all the requirements of the DCA, particularly in respect of the safety, efficacy and quality of the products. The DCA will also take into consideration as to whether the product is needed in the Malaysian market in respect of issues such as potential of abuse, number of registered products, different dosage forms and etc. Further, criteria such as whether the product provides therapeutic effect will also be taken into consideration.
Product Notification for Cosmetic Products
Effective from 1 January 2008, cosmetic products registration is no longer required and it has been replaced with online notification procedure. Regulation 18A(1)(a) of the CDCR 1984 provides that all cosmetic need to be notified with the DCA prior to being imported, manufactured, sold or supplied, unless the product is exempted under specific provision of the CDCR 1984.
Cosmetic is defined as “any substance or preparation intended to be placed in contact with the various external parts of the human body (including epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membrane of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance or correcting body odours, protecting them or keeping them in good condition”.
The company or person who is responsible for placing a cosmetic product in the market is responsible to notify the NPRA. In the event the company or person applying for the product notification is not the owner of the product, a letter of authorisation from the product owner is required during the application.
Product notification for cosmetic product is only limited to companies that are duly incorporated or registered with Syarikat Suruhanjaya Malaysia or Malaysian Registrar of Business. If a foreign company intends to bring in cosmetic products into Malaysia, they will first be required to appoint a local agent (a company registered in Malaysia) to be the holder.
The appointed agent would then be responsible for all matters pertaining to the product notification for the cosmetic products. Product notification can only be made online through the NPRA website.
All applicants must register for an access to Quest3+ online system (a system created by NPRA for the purpose of pharmaceutical and cosmetic products registration). After having access to this system, applicants will be required to fill in the notification form and to complete the process until payment submission.
The product notification number typically takes 1-3 days to be generated after the payment confirmation by NPRA to enable printing of the notification note by the applicant themselves. This notification note will serve as the authorisation to market, manufacture, import and wholesale cosmetic products. In respect of any imported product, the NPRA permits more than one importer provided that they are authorised by the responsible company who notified their cosmetic products with NPRA by issuing a copy of the notification note to the interested party. The processing fee for the product notification is RM50.00 for each cosmetic product and each variant (if any)/and it is not refundable. The product notification is only valid for two years and renewal should be done no later than one month prior to expiry.
4 Regulation 2 of the Control Drugs and Cosmetics Regulations 1984
6 Ibid 3
Justin Dominic Wong Chi Wen (Senior Associate) email@example.com
Jack Lee Yong Jie (Associate) firstname.lastname@example.org