1. Regional regulatory initiatives use different approaches
Level of reliance
Work sharing
e.g., Zazibona
Joint assessments
e.g., ACSS, EAC, ASEAN
Centralised
e.g., CRS-CARPHA, EMA
Country A
(Lead)
Country A
(speciality)
Country B
(support)
Country B
(speciality)
Country C
(speciality)
Central review
Country C
(support)
The past 5 years has seen the rapid emergence of new regional regulatory initiatives (RRIs) in which consortia of agencies work together to share expertise and resources with the goal of streamlining the regulatory review process. This coordination of efforts is based on the concept of facilitated regulatory pathways (FRPs), wherein a reliance approach is used to inform decisions by using the outcomes of prior reviews, thereby ensuring that the work conducted by the RRI is not duplicative and of “added value” for the local population. No single approach works across RRIs to implement a coordinated review process. The three main approaches that have been used to date are illustrated in this graphic.  
Australia, Canada, Singapore, Switzerland (ACSS), East African Community (EAC), Association of Southeast Asian Nations (ASEAN), Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS), European Medicines Agency (EMA)
Individual country Acceptance
Acceptance by the whole region OR
Australia, Canada, Singapore, Switzerland (ACSS); Association of Southeast Asian Nations (ASEAN); Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS); East African Community (EAC); European Medicines Agency (EMA)