By Khairul Fazli Abdul Kadir and Siti Munirah Maarof
The National Pharmaceutical Control Bureau of the Ministry of Health, Malaysia has issued the Drug Registration Document Guidance Document (DGRD) which serves as a reference for the drug registration process including quality control, inspection and licensing and post-registration activities of medicinal products.
We discuss below the general requirements for product registration based on the Control of Drugs and Cosmetics Regulations (CDCR), 1984 which was promulgated under the Sale of Drugs Act, 1952.
Registrable products
Products is defined in the CDCR as
(i) 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 medicinal purpose (ii) a drug to be used as an ingredient of a preparation for a medicinal purpose. Further, such products that shall be registered with the Drug Control Authority include:
(i) pharmaceutical products containing scheduled poisons
(ii) pharmaceutical products containing non-scheduled poisons
(iii) natural products including herbal and traditional products and
(iv) veterinary products
Products which are non-registrable include:
(a) Diagnostic agents and test kits for laboratory/invitro use;
(b) Medical devices;
(c) Food as defined under the Food Act, 1983;
(d) Sports nutrition;
(e) Raw herbs used in extemporaneous preparations;
(f) Insect repellants, insecticides, pesticides and parasiticides; and
(g) Detergents/disinfectants for domestic use.
The product registration holder
The applicant or the Product Registration Holder (“PRH”) must be a locally incorporated company, corporate or legal entity, with permanent address and registered with the Companies Commission of Malaysia. If the PRH is not the product owner, it should be authorized in writing by the product owner to be the holder of the product registration and hold responsibility towards all matters concerning the quality, safety and efficacy of the product.
Key factors for the application
Prior to the submission of an application for product registration, it is important for the PRH to determine the following aspects of the product:
(a) Category of product (different product category requires different data) - Products can be separated according to different categories such as:
(i) new drug
(ii) biologics
(iii) generics
(iv) health supplements
(v) natural products.
(b) Method of evaluation - The product will be required to undertake either full evaluation or an abridged evaluation subject to the product category.
(c) General and specific requirements - The PRH is required to submit the general and specific requirements to support an application for product registration according to the different category of the product.
(d) Conditions applied - The PRH shall comply with the conditions applied on product registration applicable according to the type of product such as the special conditions for registration for a particular product or group of products, the list of permitted, prohibited and restricted substances, labeling requirements, guideline on patient dispensing pack for pharmaceutical products in Malaysia.
(e) Multiple application - The PRH is required to make separate applications for each product in the following instances:
(i) products containing the same ingredients but made to different specifications, in terms of strength/content of ingredient(s), dosage form, description, etc.; or
(ii) different manufacturer.
(f) Variants
If a variant of the product is registered, the differences should only be in terms of fragrance, flavor or colour. The product name of the variants shall remain the same, with the addition of an identifying variant name.
(g) Language - All data and information including supporting documents for product registration such as certificates, letters and product labels shall be in English or Bahasa Malaysia.
The DGRD lists down further information on the guidelines for drug registration and is updated on a monthly basis by the National Pharmaceutical Control Bureau.