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In Malaysia, the classification of pharmaceutical products is a critical part of the Regulatory framework designed to ensure the safety, efficacy, and quality of medicines available to the public. This system is governed under the Sale of Drugs Act 1957 and the Control of Drugs and Cosmetics Regulations 1984, which lay down the legal basis for the manufacturing, importation, and marketing of pharmaceutical products.

Regulatory Authority: NPRA 

The National Pharmaceutical Regulatory Agency (NPRA), operating under the Ministry of Health (MOH), is the primary regulatory agency responsible for the classification of pharmaceutical products.

  • NPRA provides a classification form (BPFK-300).
  • While not mandatory or optional, submitting this form is highly recommended to confirm whether a product aligns with regulatory standards and classifies borderline products to determine the appropriate regulatory requirements
  • The classification considers aspects like the intended use, mode of action, and whether the product contains new chemical entities.

Drug Registration Guidance Document (DRGD) 

The DRGD offers additional guidance, especially for products that are not straightforward in classification, such as:

  • Food-Drug Interphase (FDI)
  • Medical Device-Drug-Cosmetic Interphase (MDDCI)

These are explained in detailed appendices that outline criteria and examples for accurate classification.

Categories of Medicinal Products in Malaysia 

Pharmaceutical products are registered under distinct categories, including:

  1. New Drug Products
    1. Contain new chemical entities
    2. Have not been previously approved in Malaysia
  2. Biologics
    1. Derived from living organisms
    2. Used for treatment, prevention, or diagnosis of diseases
  3. Biosimilars

a. A biologic product that is shown to be highly similar in terms of its quality, safety and efficacy to an already registered reference product in Malaysia.

  1. Generics
    1. Equivalent to brand-name drugs in strength, dosage, form, and intended use
  2. Health Supplements
    1. Supplement the diet with vitamins, minerals, herbs, or other botanicals
  3. Natural Products
    1. Include traditional and herbal remedies with therapeutic benefits
  4. Veterinary Products
    1. Intended for use in animals

Special Cases: Interphase Products 

For borderline products like FDI or MDDCI, the DRGD appendices provide comprehensive classification criteria to help companies determine the correct category.

Why Accurate Classification Matters 

  • Ensures Regulatory compliance
  • Helps companies meet the legal and regulatory requirements for manufacturing, importing, and marketing
  • Prevents legal consequences and safeguards public health

NPRA’s Role in Public Health 

The NPRA plays a vital role in:

  • Upholding a robust Regulatory system
  • Ensuring quality, safe and effective products are available
  • Ensuring regulatory product registration compliance, quality control, and post-market surveillance

Summary 

The classification process is a foundational step in Malaysia’s regulatory system. With proper classification, pharmaceutical companies can:

  • Ensure smooth product registration for borderline products
  • Avoid compliance issues
  • Gain faster market access

Need expert help navigating Malaysia's Regulatory system? Contact Freyr today.