Regulatory Classification of Drugs Malaysia

August 15, 2023

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Malaysia, like many other countries, has a robust regulatory framework in place to ensure the safety, efficacy, and quality of pharmaceutical products and medicines available in the market.

The regulatory classification of drugs plays a crucial role in governing their availability, distribution, and use. We will delve into the regulatory classification of drugs Malaysia and explore the categories and requirements for each classification.

Regulatory Classification Of Drugs Malaysia

Regulatory Classification Of Drugs Malaysia

The regulatory authority responsible for drug registration and control in Malaysia is the National Pharmaceutical Regulatory Agency (NPRA), which operates under the Ministry of Health.

The NPRA ensures that drugs marketed in the country comply with stringent standards and regulations, safeguarding public health. Drugs are classified into four main categories based on their use, risks, and dosage forms. These categories are:

Over-the-Counter (OTC) Drugs (Malaysia Drug Regulatory Authority)

Over-the-counter drugs are the first type of regulatory classification of drugs Malaysia. OTC drugs are medications that can be purchased directly by consumers without a prescription.

Common examples include pain relievers, cough syrups, antacids, and topical creams. While these drugs do not require a prescription, they still need to meet specific quality standards set by the NPRA.

They are typically considered safe and effective when used as directed. However, different outcomes will happen if they misuse it and get addicted to it. Hence, it is best to just comply with the prescribed dosage.

Prescription-Only Medicines (POM) (Drug Classification Malaysia)

Prescription-only medicines, as the name suggests, require a valid prescription from a registered healthcare professional. These drugs are usually more potent, have a higher risk profile, or require careful monitoring during use.

POMs include antibiotics, certain chronic disease medications, and drugs with potential for abuse or dependency. The NPRA closely regulates the prescribing, dispensing, and use of POMs to ensure they are used safely and appropriately.

Controlled Medicines (CM)

Regulatory Classification Of Drugs Malaysia

Controlled medicines encompass substances with a higher potential for abuse or addiction, such as opioids, benzodiazepines, and certain psychotropic medications.

These drugs are subject to stricter controls due to their psychoactive effects. Special regulations and permits are required for their manufacture, distribution, prescription, and dispensing.

The NPRA closely monitors the supply chain and usage of controlled medicines to prevent their diversion or misuse. With the presence of NPRA, Malaysia is able to monitor any drugs categorized in this type to be drastically minimized.

Traditional and Complementary Medicines (TCM)

The last category from the 4 regulatory classification of drugs Malaysia is the traditional and complementary machines. You might guess that since it is traditional medicines, it should not be regulated?

Traditional and complementary medicines include herbal remedies, traditional preparations, and traditional health supplements. These products are derived from natural sources and are often used in traditional medicine practices.

TCM products are regulated under the Traditional and Complementary Medicine Act 2013. The NPRA ensures that these products meet specific safety and quality requirements, including the absence of prohibited substances.

Regulatory Classification Of Drugs Malaysia

It is essential to note that drugs in Malaysia undergo a rigorous registration process before they can be marketed and sold in the country.

The registration process involves the submission of comprehensive scientific data on the drug’s quality, safety, and efficacy. The NPRA conducts a thorough evaluation of the data to ensure compliance with regulatory standards.

Once approved, the drug is assigned a registration number and can be legally marketed in Malaysia. All the drugs can now be obtained at your nearest registered medical stores.

The classification of drugs in Malaysia is pivotal in promoting patient safety, ensuring access to effective treatments, and preventing the misuse or abuse of certain medications.

The NPRA’s vigilant oversight and adherence to international standards contribute to the country’s healthcare system’s overall integrity and quality.

Those are the 4 regulatory classification of drugs Malaysia that you should know. If you want to seek the best supplier for your pharmacies or for personal medical purposes, you can contact us or WhatsApp us directly.