WHO collaborative registration procedure using stringent regulatory authorities' medicine evaluation: reliance in...

Area of Science:

• Regulatory Science
• Pharmaceutical Policy
• Global Health

Background:

• Lengthy regulatory approval processes hinder timely patient access to medicines in resource-limited settings.
• Reliance, leveraging evaluations from Stringent Regulatory Authorities (SRAs), offers a solution to improve efficiency.
• This approach reduces duplicated efforts and conserves resources while preserving national sovereignty.

Purpose of the Study:

• To analyze the outcomes and stakeholder experiences of the SRA Collaborative Registration Procedure (CRP).
• To evaluate the effectiveness of SRA assessments in expediting medical product approvals.
• To identify areas for improvement in reliance-based regulatory pathways.

Main Methods:

• Analysis of outcomes from the SRA CRP established in 2015.
• Examination of stakeholder experiences with SRA-led medicines assessments.
• Review of 59 approvals for 16 medicines across 23 countries via SRA CRP.

Main Results:

• The SRA CRP has facilitated 59 approvals for 16 medicines in 23 countries since 2015.
• The procedure demonstrates success in improving access and speeding up approvals.
• Positive long-term impacts are observed for resource-limited countries utilizing this reliance mechanism.

Conclusions:

• The SRA CRP effectively utilizes reliance by enhancing regulatory communication and information exchange.
• This collaborative approach leads to faster regulatory approvals and earlier patient access to medicines.
• Recommendations include developing guidance for post-approval changes and promoting wider adoption of the procedure.