NPRA of Malaysia Implements Fast-Track Review for Clinical Trials

On 18 June 2020, the National Pharmaceutical Regulatory Division (NPRA) of Malaysia has published a circular announcing a fast-track review for clinical trials applicable for clinical trial import license applications and unauthorized manufacture of unregistered products for clinical trial purposes.

This working procedure was tabled and approved by the Drug Control Authority (DCA) at its 345th meeting.
The criteria for fast-track review include the application of new research products used for treatment/prevention in pandemic/epidemic situations for public health except for the First-in-Human (FIH) study.

The existing application and evaluation procedures remain unchanged except for a shorter application evaluation period than the available procedure.
There are two categories of the product, one being a biological product, Cell & Gene Therapy Products( CGTP), herbal products with therapeutic claims that only require 22 business days as compared to 45 business day within the standard review.

Other products that do not fall in Phase 1 Category require 14 business days under the fast track review as compared to 30 business days within the standard review.

The implementation is effective from 01 April 2020 onward.

For more information, kindly refer to :- https://www.npra.gov.my/index.php/en/component/content/article/40-english/circulars/1527115-pekeliling-berkenaan-pelaksanaan-prosedur-kerja-fast-track.html?Itemid=1391