Overview

There are several innovations recommended in this Pandemic Preparedness and Response Playbook to accelerate vaccine development that are not currently defined in guidelines in many countries. Use of these innovations may require upfront agreement by National Regulatory Agencies, which will take time to negotiate, so early engagement is recommended. That is particularly true for developers that have a high-potential product. 

Engaging regulators one-on-one can be very effective, but it may be infeasible in the event of a Public Health Emergency. Two mechanisms that can be used to gain alignment during early development of regulatory strategies across many are provided below.

Former COVAX Regulatory Advisory Group

The COVAX Regulatory Advisory Group was created during the COVID-19 pandemic and consists of members from National Regulatory Authorities covering all WHO regions, including Africa (Ghana and South Africa), Americas (Argentina, Brazil, Canada, and US), Europe (EMA, EDQM, UK), Southeast Asia (India, South Korea), Western Pacific (Australia, Japan and Singapore).

While COVAX was disbanded on 31-Dec-2023, the former COVAX Regulatory Advisory Group continues to meet to discuss current and emerging epidemic and pandemic risks and align on ways to address them.

International Coalition of Medicines Regulatory Authorities (ICMRA)

International Coalition of Medicines Regulatory Authorities (ICMRA) is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together to

• address current and emerging human medicine regulatory and safety challenges globally, strategically and in an on-going, transparent, authoritative and institutional manner

• provide direction for areas and activities common to many regulatory authorities' missions

• identify areas for potential synergies

• wherever possible, leverage existing initiatives/enablers and resources

ICMRA will provide a global architecture to support enhanced communication, information sharing, crisis response and address regulatory science issues. [1]