Malaysia: NPRA's Transition to Remote GDP Inspections (w.e.f. 18 December 2024)

The National Pharmaceutical Regulatory Agency (NPRA) has introduced a progressive initiative to improve the regulatory process for pharmaceutical distribution in Malaysia. Remote inspections for Good Distribution Practice (GDP) certification, or Amalan Pengedaran Baik (AEB), will now be implemented as a standard practice alongside traditional on-site inspections. This move marks a significant milestone in ensuring industry efficiency, adaptability, and compliance.

Key Highlights of the Implementation

1. Immediate Implementation

The initiative is effective as of the date of the notification letter (18 December 2024), signaling NPRA’s commitment to rapidly adopting innovative solutions

2. Remote Inspection as a Standard

Remote GDP inspections were initially introduced during the COVID-19 pandemic. Due to their effectiveness, they are now established as a regular practice, providing an alternative to on-site assessments. This method ensures that inspections are conducted efficiently without compromising safety and quality.

3. Broad Scope of Application

The implementation of remote inspections extends beyond first-time and pre-licensing assessments. It also applies to other types of inspections, subject to NPRA’s risk-based evaluation matrix. This ensures a comprehensive and equitable approach to regulatory oversight.

4. Streamlined Licensing Process

Enhancements have been made to the application and renewal processes for import and wholesale licenses. These improvements are part of a broader effort to modernize pharmaceutical regulations and ensure compliance with global best practices.

5. Support and Guidance

For additional clarity, stakeholders can refer to the Frequently Asked Questions (FAQ) document on the NPRA website.

The adoption of remote GDP inspections reflects NPRA’s dedication to maintaining high standards in the pharmaceutical supply chain. By leveraging technology, the agency not only ensures compliance but also enhances the efficiency of regulatory processes. This initiative is a testament to NPRA’s forward-thinking approach to safeguarding public health.

Source: National Pharmaceutical Regulatory Agency (NPRA)