Malaysia: Circular Update of GMP Requirements for CTIL Application for Foreign Manufacturers

The National Pharmaceutical Regulatory Agency (NPRA) published a circular on updating the Good Manufacturing Practice (GMP) requirements for foreign manufacturers in the application of Clinical Trial Import Licenses (CTIL).

Currently, the GMP requirements for foreign manufacturers of investigational products are required to provide the following:

1. For manufacturers in Pharmaceutical Inspection Co-operation Scheme (PIC/S) member countries, valid GMP compliance certificates are issued by the participating authority of member countries.

2. For manufacturers from a non-PIC/S member country that has been inspected by a recognized regulatory authority, a valid Certificate of GMP Compliance issued by the inspecting regulatory authority can be used for the application.

However, the demands and needs of the current developments have led NPRA to agree on updating the GMP documents requirements for foreign manufacturers in applying for CTIL to:

• GMP certificate from PIC/S member country, or

• GMP certificate from International Council for Harmonization (ICH) Regulatory Member country, or

• Qualified Person’s (QP) Declaration of Equivalence to European Union Good Manufacturing Practice (EU GMP) for Investigational Medicinal Product (IMP) and QP registration verification documents by the Europe-authorized body.

The circular is effective immediately as the released date, 11 May 2023, and will be updated in the Malaysian Guideline for Application of Clinical Trial Import Licenses (CTIL) and Clinical Trial Exemption, 8th Edition, published on September 2023.

Source: National Pharmaceutical Regulatory Agency (NPRA)

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