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Malaysia NPRA implement Guideline on Facilitated Registration Pathway: Abbreviated and Verification Review with the aim of increasing the efficiency of the NPRA in pharmaceutical product registration.

**1.1 Background **
An effective regulatory system is an essential component of health system strengthening and contributes to better public health outcomes. In order to improve regulatory capacity and efficiency, the National Pharmaceutical Regulatory Agency (NPRA) published the first edition of the Facilitated Registration Pathway (FRP) guideline in 2019. The guideline is developed based on reliance concept. The reliance mechanism is applied by leveraging the work performed by other regulatory bodies on the same products intended for the local market. This mechanism is initiated to reduce duplication of effort and enable NPRA to emphasize the risk-based approach in both pre and post-market authorization activities. Reliance procedures provide a more efficient review process and ultimately early access to pharmaceutical products in the market.

**1.2 Objectives **
This guidance document is intended to provide a transparent and consistent procedure in the utilization of the reliance approach.

The guideline describes the procedures, requirements for submitting the application to register a product via this pathway and serves as a supplementary document to Drug Registration Guidance Document (DRGD). The applicant should refer to both documents before completing product registration application via QUEST system.

**1.3 Scope **
The scope of this guideline applies to new drug products, generic medicines and biologics including cell and gene therapy products (CGTPs).

The final decision for a product to be considered via FRP is subject to NPRA discretion. NPRA may decide based on the eligibility criteria stated in this guideline, which may include risk-benefit assessment, country priorities, public health needs, and other reasons or opportunities for reliance.

**1.4 Review Pathways **
The following review pathways will be used to assess products eligible to be submitted via FRP:

• Abbreviated review: A limited independent assessment of specific parts of the dossier, or submission for suitability of use under local conditions and regulatory requirements, while relying on prior assessment and inspection outcomes from a reference authority or trusted institution to inform the local decision. OR
• Verification review: Review of the sameness of the product dossier to ensure that the medical product is the same as the one that has been assessed by ASEAN Joint Assessment.

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