The Abridged Route pathway has been developed by the Brunei Darussalam Medicines Control Authority (BDMCA) of Brunei Darussalam.
When relevant, the agency relies on prior decisions from Australia Canada EU-EMA Malaysia Singapore United Kingdom United States
1. Assessment by Product Regulation Team and Drug Registration Committee (DRC) • Generic: 132 working days • New Chemical Entity/Vaccines/Biologics: 246 days 2. Endorsement by Brunei Darussalam Medicines Control Authority (BDMCA): 45 Working days