Entering The Malaysian Pharmaceutical Market: A Step-By-Step Guide For Potential Entrants
In 2025, Malaysia’s Pharmaceutical Market revenue is expected to reach US$1.74 billion. For any company looking to tap into this lucrative market, understanding the local regulatory landscape is the first and most critical step. This landscape is primarily governed by the Control of Drugs and Cosmetics Regulations 1984 (“CDCR 1984”), enforced by the Drug Control Authority (“DCA”) under the National Pharmaceutical Regulatory Agency (“NPRA”) of the Ministry of Health.
According to Regulation of the CDCR 1984, “product” is defined as 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. For instance, biologics, generic drugs, including prescription medicines and Over The Counter (OTC) products, traditional medicines, veterinary products, and health supplements all fall under the purview of the CDCR 1984.
This article aims to present a general overview of the legally mandated processes for product registration, regulatory compliance, and post-registration obligations.
