The Expedited Joint Assessment Procedure pathway has been developed by the ASEAN of ASEAN.
This pathway can be used where 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 timelines, by each individual NRA through their normal decision-making process based on the joint assessment report and, where applicable, nationally-relevant considerations. Notes announcing priority therapeutic areas and indications will be periodically posted on ASEAN NRAs websites inviting expressions of interest from applicants for the submission of applications for joint assessment candidate product selection. Although there is preference for products within the priority areas, applicants can submit applications for other products - outside priority areas - for consideration by ASEAN NRAs as long as the products have already been approved by a reference NRA, prequalified by WHO, or assessed through special regulatory pathways such as EU Article 58 or US FDA tentative approval. In addition, products should be manufactured in a PIC/S-GMP compliant site (documentary verification only, no inspections foreseen). List of priority Finished Pharmaceutical Product types/categories for ASEAN Joint Assessment Procedure: https://www.hsa.gov.sg/docs/default-source/gdo/international-collaboration/asean/listof-1b76330e3338e48ec8d2b40957bb23b0a.pdf .
Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Brunei Darussalam Cambodia Indonesia Lao People's Democratic Republic Malaysia Myanmar Philippines Singapore Thailand Vietnam
When relevant, the agency relies on prior decisions from Australia Austria Belgium Bulgaria Canada China Croatia Cyprus Czech Republic Denmark EU-EMA Egypt Estonia Finland France Germany Ghana Greece Hungary Iceland India Indonesia Ireland Italy Japan Latvia Liechtenstein Lithuania Luxembourg Malta Netherlands Nigeria Norway Poland Portugal Romania Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sweden Switzerland Tanzania Thailand United Kingdom United States Vietnam WHO
The following timelines apply if the following preconditions are met: 1. The joint assessment report recommends granting marketing authorization; 2. The applicant complies with specific requests included in the joint assessment report; 3. The applicant complies with applicable national administrative requirements. Regulatory decision-making at country level: Brunei Darussalam = 60 working days; Cambodia = 90 working days; Indonesia = 45 working days; Lao PDR = 45 working days; Malaysia = 30 working days; Myanmar = 90 working days for normal situation and 60 working days for urgent public health needs situation; Philippines = 30 working days; Singapore = 30 working days; Thailand = 30 working days; and Viet Nam = 60 working days.