NPRA Malaysia Mandates Declaration of Competent Personnel for GMP Compliance in Clinical Trial Products

Details of the Update

Under the new directive, applicants must submit a Declaration of Competent Personnel as formal evidence of GMP compliance when investigational medicinal products are manufactured in jurisdictions where authorities do not issue official GMP certificates. This includes products sourced from China, the United States, ASEAN countries, and other regions without GMP certification frameworks.

The declaration must confirm that manufacturing activities are equivalent to ICH or PIC/S GMP standards. It must also include audit details conducted by qualified personnel or, where audits are not performed, a written justification explaining the rationale. Based on the submitted declarations, manufacturing sites may be subject to NPRA inspection as part of the review process.

All new CTIL and CTX applications involving investigational medicinal products from impacted regions are required to comply with these provisions.

Why It Matters

This directive provides regulatory clarity for clinical trial sponsors sourcing investigational medicinal products from countries without GMP certification issuance. By formalizing alternative GMP evidence through a Declaration of Competent Personnel, NPRA supports regulatory alignment with international standards, enhances oversight efficiency, and maintains compliance assurance while minimizing procedural barriers to clinical trial approvals.

Who This Is Relevant For

The update is relevant for Regulatory Affairs, Quality Assurance, Clinical Operations, and Compliance teams, as well as manufacturers, importers, and sponsors involved in the import or manufacture of investigational medicinal products for clinical trials in Malaysia.

Next Steps

Stakeholders should review current and upcoming CTIL and CTX applications to identify investigational medicinal products sourced from affected jurisdictions. Regulatory Affairs teams should coordinate with Quality Assurance to prepare the required Declaration of Competent Personnel, ensuring GMP equivalence statements, audit documentation, or written justifications are complete and aligned with NPRA expectations. Internal supplier qualification and documentation processes should also be reviewed and updated to support ongoing compliance.

As regulatory requirements for clinical trial products continue to evolve across jurisdictions, RegASK supports teams in staying aligned with local GMP expectations and submission requirements. RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that empowers global organizations in highly regulated sectors, including consumer products and life sciences, to proactively navigate complex regulatory landscapes. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely predictive actionable insights and end-to-end automation, streamlining compliance processes, mitigating risks, and accelerating market access across more than 160 countries. Learn more or book a demo now.

FAQs

What is a Declaration of Competent Personnel under the NPRA directive? 

It is a mandatory document confirming GMP compliance for investigational medicinal products manufactured in jurisdictions that do not issue official GMP certificates.

Which applications are affected by this requirement?

All new CTIL and CTX applications involving investigational medicinal products sourced from affected regions must comply.

What GMP standards must be referenced in the declaration?

The declaration must confirm GMP equivalence to ICH or PIC/S standards, supported by audit details or written justification.

How can RegASK help organizations comply with this NPRA directive?

RegASK helps Regulatory and Quality teams track NPRA updates, assess applicability to ongoing clinical trials, and streamline documentation workflows needed to support GMP compliance declarations.