NPRA Product Registration Services in Malaysia

NPRA Product Registration

National Pharmaceutical Regulatory Agency (NPRA)

NPRA was established to implement quality control on pharmaceutical products. NPRA ensures the quality, efficacy and safety of pharmaceuticals through a registration and licensing scheme. Cosmetics must be notified and medicinal products and health supplements registered. These products cannot be placed on the Malaysian market until their scientific data and laboratory tests have been evaluated and approved by NPRA and given their respective Cosmetic NOT number or MAL registration number.

NPRA Product Registration in Malaysia

Cosmetics

If you are the Cosmetic Notification Holder (CNH), you are responsible for ensuring that the cosmetic has been notified with NPRA. Information such as ingredients, formula, labelling, claims must be checked for permissibility prior to submission to NPRA. Cosmetics are issued with a Notification number (NOT number).

Health Supplements

To register health supplements, you need to prepare a well-structured dossier application with information on the product particulars, formula, packaging, labelling, quality control and claims substantiation. Information such as dosage form, active ingredients, indication for use, contraindications, target population, stability, shelf life, batch size, packaging, certificate of Pharmaceutical Product (CPP) or Certificate of Free Sale (CLS) and Good Manufacturing Process (GMP) are some of the required data.

Natural Products

Natural products include traditional medicines, herbal products, homeopathic medicines and natural products with therapeutic claim. They are evaluated based on the criteria for safety and quality of the product, and where appropriate, efficacy and/or claimed benefits. Checks must be done on the ingredients, labelling, quality and stability of the product and a certificate of analysis for the active ingredients as well as one for the finished product must be submitted as part of the registration process.

Medicinal Products

Drug registration is a lengthy process – it involves the preparation and submission of the application to NPRA who will then screen, evaluate and advise of the regulatory outcome. During the process, there may be requests for clarifications, additional information and reports. You must apply for a QUEST 3+ token, classify the product category, check the patent and data exclusivity status, prepare the registration dossier in ASEAN CTD format, pay the fees and submit the application to NPRA.

Quest 3+

All cosmetic notifications, product registrations, licencing and market sampling are done using the Quest 3+ on-line system. The system holds a list of all licenced manufacturers, importers and wholesalers.

Malaysia Product Registration Service for NPRA

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