Asia – Asia-Pacific Roundup: Malaysia publishes guidance on manufacturing cell and gene therapies

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has released guidance about cell and gene therapy manufacturing facilities. The guidance describes the process for setting up a facility in Malaysia and the local and international regulations and guidelines that cover the production of cell and gene therapies.

NPRA has provided a step-by-step guide to the regulatory side of setting up a facility to manufacture higher-risk cell and gene therapy products in Malaysia. The first step is to submit an application for the evaluation of the layout of the manufacturing plan along with the supporting documents and a processing fee. Manufacturers can only start setting up the pharmaceutical quality system (PQS) after receiving approval for the facility layout.

Preparation of the PQS is covered by guidelines such as the PIC/S Guide to Good Manufacturing Practice for Medicinal Products. NPRA will apply the guidelines to activities including construction of the manufacturing facility, the qualification of equipment and establishment of documentation about the training of personnel…