Pharmaceutical Product Registration

Front

What is the purpose of product registration under the CDCR 1984?

Back

To ensure that products available on the local market are efficacious, of quality, and safe for human use.

Front

What does the term 'product' refer to under the CDCR 1984, Regulation 2?

Back

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.

Front

What are the categories of registrable products in pharmaceuticals?

Back

1. New Drugs 2. Generics 3. Biologics 4. Complementary Medicines 5. Traditional Medicines 6. Health Supplements

Front

What is a New Drug Product (NDP)?

Back

Any pharmaceutical products that have not been previously registered in accordance with the provisions of the CDCR 1984.

Front

What is a Generic Medicine?

Back

A product that is essentially similar to a currently registered product in Malaysia.

Front

What are the two types of Scheduled Poisons?

Back

Group A (Prescription Medicines) and Group B (Non-Prescription Medicines).

Front

What is the registration timeline for OTC products?

Back

Abridge Evaluation: 116 WD for single API, 136 WD for combi API; Full evaluation: 210 WD.

Front

What is the role of the Product Registration Holder (PRH)?

Back

The PRH must be a locally incorporated company responsible for all quality, safety, and efficacy information submitted in support of the product registration application.

Front

What is the significance of the Poison Act 1952 in pharmaceutical registration?

Back

It categorizes drugs and substances intended for medicinal purposes, including scheduled poisons.

Front

What is the regulatory outcome for product registration?

Back

Registration number is assigned, valid for 5 years, with updates and renewals required for maintenance.