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 processes, encourage applications and assist applicants in the procedures, as well as a JAIMS demo to support the stakeholders understanding of the platform used for product submissions management (Joint Assessment Information Management System – JAIMS). The documents and link are as follow:

1. ASEAN Joint Assessment Procedure for Pharmaceutical Products: Information for applicants – Revision 2 (November 2022)
2. List of Priority Products for JA Activities – Revision 2 (November 2022)
3. Frequently Asked Questions (FAQ) on the ASEAN Joint Assessment (JA) Procedure – Revision 2 (November 2022)
4. JAIMS demo link: https://youtu.be/IAwtK2iV-UQ