Malaysia NPRA Issues Directive on Registration and Enforcement of Cell and Gene Therapy Products(CGTPs) in Stages

On 14 Dec 2020, Malaysia NPRA issues Directive 19 of 2020 on Registration And Enforcement Of Cell And Gene Therapy Products(CGTPS In Stages And Additional List Of Products  Outside The Scope of  CGTPS Controlled by DCA. Registration And Enforcement By Stage For
Cell And Gen Therapy Products (CGTPS)

1.0          Scope
The scope of the product involved is the product that is already on the market in Malaysia for at least one year (starting on 1 January 2020 and before) but has not been able to meet the regulatory requirements of the dossier full registration.

2.0        Implementation Mechanism

2.1        For products that meet the scope, flexibility will be provided during this transition period. There are two stages in this transition period; first-stage screening and second stage screening. These products can still be marketed if it passes the first and second screening stage.

2.1.1       First-level screening:
The company can submit an application for stage screening first manually when the document is complete. If the product passes first stage screening, the product will be included in the list of products that can be marketed until 1 July 2022.

Documentation required during first stage screening:

1)           CGTPs manual screening form which includes basic information such as product name, mechanism of action indication, dosage, route of administration, active ingredients, eksipien dill. (Form in Appendix B)

2)           Invoice/sales record in Malaysia (minimum: 1 year) including name & recipient’s identity card number

2.1.2     Second stage screening
Products that have passed the first stage screening need to submit an application for second stage screening manually before 1 July 2022. If passed the second stage screening, the product will remain on the list and can be marketed until 31 December 2024.

More information could be obtained here :
Direktif berkenaan pelaksanaan pendaftaran produk dan penguatkuasaan secara berperingkat bagi produk terapi Sel dan gen (cgtps) serta tambahan senarai produk di luar skop kawalan cgtps oleh pbkd

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