##  [What is the Classification of Pharmaceutical Products in Malaysia?](/what-is-the-classification-of-pharmaceutical-products-in-malaysia) 

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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.