Module 9 2024

03/09/2024

Regulatory Processes for Global Access

For access to UN procurement:

Relies on Stringent Regulatory Authority, SRA (country of manufacture)

WHO prequalification (vaccines)

F Mechanism to assess quality, efficacy and safety of product supplied to UN agencies

Special focus on relevance of data*

May require national registration in UN recipient country

For wider access to Low and Middle Income Countries (LMICs), examples:

Collaboration with WHO and regulators/experts from LMICs where intended to be used

Scientific opinion for medicines intended for use outside the EU

EU Medicines for All or EU M4all

F

Collaboration with WHO and regulators/experts from LMICs where intended to be used

PQ used as reference for CRP in LMICs (n.b. there is a similar CRP with a SRA reference)

Collaborative Registration Procedure (PQ)

The Organisation for Professionals in Regulatory Affairs

*target population, lot testing, GMP inspection, and Programmatic Suitability aspects (PSPQ)

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Prophylactic Vaccines Can be Treated More Stringently – Examples in Asia

China

• Phase I paediatric overseas data must be available for simultaneous development program for a

paediatric vaccine (may be more flexibility in future)

• Vaccine sample size requirements usually larger than therapeutic products, > 500 in phase III

• No Contract Manufacturing Organisation allowed at NDA or in late phase III studies

• Lot release for clinical lots (as well as marketed)

• Require national lab testing for certain variations e.g., change of test

Japan

• Registration and routine marketed lot testing (opportunities to waive or reduce testing in future)

Singapore

• Vaccine lot release notification is required for every batch of all registered vaccines when

imported for supply since 1 Jul 2022

Taiwan

• New vaccines - clinical trials conducted in TW required

• Registration sample testing and per batch commercial lot testing by national lab is required

The Organisation for Professionals in Regulatory Affairs

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