The National Pharmaceutical Regulatory Agency (NPRA) is the central authority responsible for regulating pharmaceutical products in Malaysia. Operating under the Ministry of Health (MOH), it ensures that medicines, health supplements, traditional medicines, and cosmetics meet stringent safety, efficacy, and quality standards.

Roles and Responsibilities of NPRA:

1.Product Registration:

a. Evaluates and approves pharmaceutical products for safety, efficacy, and quality.

b. Requires comprehensive documentation and clinical data for market entry.

2. Licensing:

a. Regulates manufacturers, importers, and wholesalers through licensing.

b. Conducts routine inspections to ensure adherence to Good Manufacturing Practices (GMP).

3.Pharmacovigilance:

a. Monitors the safety of medicines post-market through adverse drug reaction (ADR) reporting systems.

b. Identifies and mitigates risks associated with pharmaceutical products.

4. Import and Export Controls:

a. Enforces strict regulations to prevent counterfeit or unregistered products from entering or leaving the market.

5. Post-Market Surveillance:

a. Conducts regular monitoring of products available in the market to ensure compliance with regulatory standards.

6.GMP Certification:

a. Assesses manufacturing facilities to ensure compliance with international GMP standards.

Key Contributions of NPRA:

• Safeguards public health by maintaining a robust regulatory framework.
• Strengthens Malaysia’s position as a trusted pharmaceutical hub in the ASEAN region.
• Encourages innovation while maintaining high-quality standards for healthcare products.

Why Choose Freyr Solutions?

Freyr Solutions is your go-to partner for all regulatory needs in Malaysia. With a dedicated team of experts and reliable local partners, Freyr offers:

• Comprehensive support for product registration and licensing.
• Guidance on GMP certification and compliance audits.
• Expert assistance in navigating NPRA’s regulatory requirements seamlessly.

Trust Freyr Solutions to simplify your compliance journey and accelerate your success in the Malaysian market. Together, we ensure your products meet the highest regulatory standards with ease.