Malaysia: Implementation of the Updated Guideline FRP by NPRA (1 January 2024)

ARQon
Nov 21, 2023
2 min read

On the 390th meeting on the 3rd of November 2023, the National Pharmaceutical Regulatory Authority (NPRA) agreed to update the Guideline for Facilitated Registration Pathway (FRP), Revision 1, 2023 and will be enforced effectively from 1 January 2024.

The revision was decided to align the Guideline FRP for pharmaceutical-related products that have been approved by the WHO Collaborative Registration Procedure (CRP) or assessed by the ASEAN Joint Assessment (AJA).

As previously in 2020 and 2022, NPRA representing Malaysia joined WHO CRP for Products Authorized by WHO Stringent Regulatory Authorities (SRAs), WHO prequalified (PQ) medicines and vaccines, ASEAN Joint Assessment (AJA) for joint product evaluation, and chaired the AJA Coordinating Group (JACG), the rollouts were important to ensure NPRA is competent and efficient in providing thorough services.

Furthermore, NPRA approved the addition of the Health Canada (Canada), Pharmaceuticals and Medical Devices Agency (PMDA - Japan), Swissmedic (Switzerland), Therapeutic Goods Administration (TGA - Australia), and Medicines and Healthcare products Regulatory Agency (MHRA – United Kingdom) into the approved reference authorities. This initiative helps to shorten the assessment period and increase the volume of the products to be assessed via the FRP procedure at once.

Among the revised aspects in the Guideline FRP can be referred to below:

Product scope expansion: Covering new drug products, generic medicines, and biologics including cell and gene therapy products (CGTPs)
Addition reference authorities for procedures as stated above
Abbreviated Review for WHO CRP & all products that have been approved by the stated reference authorities above
Verification Review applicable for ASEAN Joint Assessment
Submission of the application period to NPRA from the approval date by the reference authorities is extended to 3 years
The revision timeline for the Abbreviated Review was shortened to 90 working days and the Verification Review shortened to 30 working days

All product registration holders should be alert to the important changes and dates to avoid product disruption in the market. For more details on the updated guideline, can refer here (Guideline for Facilitated Registration Pathway (FRP), Revision 1, 2023)

Source: National Pharmaceutical Regulatory Authority (NPRA)