The ASEAN harmonized requirements for drug registration (SIAHR)- Full JA pathway has been developed by the ASEAN-SIAHR of ASEAN.
This pathway can be used where 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. .
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
For product selection: Up to 135 calendar days. For Joint Assessment: 150 days (140 if no meeting required) (Review of applications will start only after all participating NRAs have received the application(s) and related documentation and have considered it accepted for assessment). Target times for decisions to be made by individual countries vary as follows: ASEAN Member State Timeline (working days) Brunei Darussalam 60 Cambodia 90 Indonesia 45 Lao PDR 45 Malaysia 30 Myanmar 90 for normal situation 60 for urgent public health needs situation Philippines 30 Singapore 30 Thailand 30 Viet Nam 60