1 min read

Listen to What Is...?

What is Malaysia’s Pharmaceutical Registration Process?

Malaysia’s pharmaceutical market is regulated by the National Pharmaceutical Regulatory Agency (NPRA), ensuring that all drugs meet stringent safety, efficacy, and quality standards. Pharmaceutical companies looking to enter the Malaysian market must navigate the NPRA registration process while complying with Good Manufacturing Practices (GMP), WHO, and ICH guidelines.

Key Submission Requirements

To register a pharmaceutical product in Malaysia, companies must submit:

  • Clinical Data for New Chemical Entities (NCEs)
  • Bioequivalence Studies for generic drugs
  • Product Monograph detailing dosage, safety, and ingredients
  • Compliant Labeling in accordance with local language and regulatory standards

NPRA Approval Process

The NPRA regulatory process consists of five essential stages:

  1. Pre-Submission Consultation – Engaging with NPRA to clarify regulatory requirements.
  2. Dossier Preparation – Compiling the registration dossier, including clinical, manufacturing, and quality data.
  3. Submission to NPRA – The dossier is reviewed for safety, efficacy, and compliance.
  4. NPRA Evaluation – NPRA conducts a detailed review and may request additional data.
  5. Approval & Post-Approval Monitoring – Once approved, products receive market authorization, followed by continuous post-market surveillance.

The Role of a Local Representative

A Product Registration Holder (PRH) is mandatory for regulatory submissions. This entity must be registered with Malaysia’s Companies Commission (SSM) to act as the local regulatory representative.

Ensuring a Smooth Approval

Failure to meet NPRA compliance can lead to delays or rejection. Companies must ensure well-prepared dossiers and strict adherence to regulations to expedite approval and market entry.

Freyr Solutions: Your Regulatory Partner

Freyr Solutions offers end-to-end regulatory support, from product registration to compliance and post-market monitoring, ensuring a seamless approval process in Malaysia.

Looking to launch your pharmaceutical products in Malaysia? Contact Freyr Solutions today!