Snapshot

The Abridged Route pathway has been developed by the Brunei Darussalam Medicines Control Authority (BDMCA) of Brunei Darussalam.

It is an abridged review (a reliance pathway).

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