Regulatory Oversight of Cell and Gene Therapy Products in Malaysia.

The National Pharmaceutical Regulatory Agency (NPRA) is the agency responsible for the registration of pharmaceutical, natural, and health supplement products and notification of cosmetic products that are marketed in Malaysia. The implementation of regulatory oversight of the different types of product was in a progressive manner, with the latest addition to be regulated being the cell and gene therapy products (CGTPs), beginning January 1, 2021. CGTP can be classified as low risk (that does not require registration) or high risk (that needs to be registered).

Correction to: An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology.

The authors have revised Figure 1. The revised figure is presented below.

An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology.

Introduction: The National Pharmaceutical Regulatory Agency (NPRA) embarked on a regulatory-strengthening program and is evaluating its processes. Optimising Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that provides benchmarking data that can define performance targets and focus performance improvement. The objective of this study was to use OpERA methodology to determine where time is spent in the NPRA approval process and to form a baseline to measure the performance improvements.