ASEAN Joint Assessment Procedure for Pharmaceutical Products Public Announcement

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The National Medicines Regulatory Authorities (NRA) of ASEAN Member States have developed a new procedure for marketing authorizations: the ASEAN Joint Assessment Procedure. The pilot JA project supported and advised technically by the WHO which started in July 2017 has completed. This is a public announcement for a new JA candidate product. 

 

 

ASEAN Joint Assessment Procedure for Pharmaceutical Products

Introduction

 In 2015, the PPWG started a WHO-supported project aimed at strengthening the implementation of ASEAN harmonized regulatory requirements (SIAHR). The PPWG discussed project outcomes and decided that issues related to different implementation or interpretation of harmonized requirements can be addressed through further cooperation among NRAs, such as joint assessment of applications for marketing authorization, hands-on training, and other similar activities where staff of different NRAs can work together. The PPWG also recognized that these measures require important funding and specific input from other parties such as industry and ad hoc expertise from well-resourced NRAs.

On this basis, the PPWG initiated work towards the establishment of the Joint Assessment Coordinating Group (JACG) to focus on activities aimed at intensifying collaboration among ASEAN NRAs, respecting national decision-making processes.

The JACG work is based on the following guiding principles:

  • Most regulatory authorities face limitations which prevent them from performing all regulatory functions at the highest possible level of competence, efficiency, and effectiveness.
  • Harmonization and cooperation are essential to ensure that no regulatory work is conducted in isolation, without taking into account that a similar product or manufacturing site has been or is being assessed in several other countries by authorities with different capacity, resources, and skills.
  • Harmonization and cooperation lead to improving access to essential medicines and building stronger regulatory capacity and trust.

The JACG has developed three (3) main procedural documents to guide the joint assessment process, encourage application and assist applicants in the procedures, as well as JAIMS demo to support the stakeholders understanding of the platform used for product submissions management (Joint Assessment Information Management System - JAIMS):

 

 

4.       JAIMS demo link: https://youtu.be/IAwtK2iV-UQ 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

 

 

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