ASEAN Joint Assessment Procedure for Pharmaceutical Products (JAP)

Introduction

 Joint assessment is a formal procedure in which the same application is simultaneously submitted to all participating ASEAN National Medicines Regulatory Authorities (NRAs). Assessment work is then carried out together by all participating NRAs and a joint assessment report is prepared. At the end of the process, the final decision on the application is then taken, within established time lines, by each individual NRA through their normal decision-making process based on the joint assessment report and, where applicable, nationally-relevant considerations.

Applications can be submitted via three (3) different routes: 1). the responsive application route: applications concerning products that are included in the priority lists published by ASEAN NRAs; 2). the proposed application route: applicants propose products that are not included in the priority lists published by ASEAN NRAs; 3). the invited application route: applicants are approached by ASEAN NRAs or WHO and invited to submit an application for a product of important public health value.


For each route, two (2) regulatory pathways are available: the 1) full JA procedure and the 2) expedited JA procedure. For both procedures the full application dossier is uploaded by the applicant to the dedicated IT platform developed by WHO. The applicant also provides all participating NRAs with access to detailed assessment reports of the product (scientific evaluation and inspections reports)1 generated by a reference NRA or WHO.

For further information, please refer to the documents and links below:

1. ASEAN Joint Assessments: Information for Applicants  PDF
   
2. Frequently Asked Questins (FAQ) onthe ASEAN Joint Assessment (JA) Prcedure PDF
   
3. ASEAN Joint Assessment Procedure Public Announcement  PDF
   
4. List of Priority Products for JA Activities   PDF
    
   
5. JAIMS demo link: https://youtu.be/IAwtK2iV-UQ