Member Article

Pharmaceuticals and medical devices in Malaysia are governed by the following main legislation and regulations:

• the Sale of Drugs Act 1952 (SODA 1952);
• the Control of Drugs and Cosmetics Regulations 1984 (CDCR 1984);
• the Dangerous Drugs Act 1952 (DDA 1952);
• the Poisons Act 1952 (PA 1952);
• the Medicines (Advertisement and Sales Act) 1956 (MASA 1956); and
• the Medical Device Act 2012 (MDA 2012).

The main regulatory bodies for pharmaceuticals and medical devices are the:

• Drug Control Authority (DCA);
• Pharmacy Board (PB);
• National Pharmaceutical Regulatory Agency (NPRA);
• Medicine Advertisement Board (MAB); and
• Medical Device Authority (MDA).

All of the above legislation and regulatory bodies are under the purview of the Malaysian Ministry of Health (MOH).

Challenging Decisions of Regulatory Bodies Appeals may be made against the decisions of the regulatory bodies in accordance with the procedure set out in the applicable Act or Regulations.

Under Regulation 18, CDCR 1984:

• any person aggrieved by the decision of the Authority or the Director of Pharmaceutical Services may make a written appeal to the Minister of Health for Malaysia;
• all notice of appeals shall be made within 14 days from the date of notification from the Authority; and
• any decision of the Minister made on an appeal shall be final.

Nevertheless, a person who is adversely affected by a decision, action or omission in relation to the exercise of a public duty or function shall also be entitled to make an application to the court for judicial review, pursuant to Order 53 of the Rules of Court 2012. The remedies which may be sought under the judicial review application are:

• mandamus (peremptory or mandatory order);
• certiorari (quashing order);
• prohibition (prohibition order); and
• damages.

Pharmaceutical products are categorised into:

• those containing the scheduled poison(s) listed in the PA 1952;
• those containing active ingredients which are not listed in the PA 1952 and not categorised as health supplements or natural products or cosmetics which may be freely available over the counter.