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Thursday, February 9, 2017

What is the ICMRA?

What is the ICMRA?
The ICMRA is a venue for heads of national regulatory authorities around the world to enable a shared strategic leadership to address current and emerging global regulatory challenges and to better leverage resources in ways that expand global regulatory reach.


(1). what sets the ICMRA apart from other existing regulatory initiatives is that it brings together senior leaders to provide strategic, high-level advocacy and leadership.
ICMRA can provide direction for a range of areas and activities that are common to many MRAs’ missions and goals, identify areas for potential synergies to be made, and wherever possible, leverage existing efforts to maximize global impact. Four over-arching objectives help to guide the ICMRA: • to protect human health throughout the life-cycle of medicinal products;
  • To enable regulatory conditions which facilitate improved access to and availability of safe, efficacious and quality medicinal products. This also includes enabling innovation and advancing regulatory science as it related to medicine research and development;
  • To promote coherent and strategic multilateral cooperation among regulatory authorities, in order to strengthen mutual reliance, trust, synergies and regulatory systems, and to achieve better use of collective resources/work products and sharing of best practices; and
  • To promote the leveraging of regulatory authorities’ resources, including knowledge and expertise.
ICMRA has a medicines focus at this stage, and participants are currently working on selected joint efforts to stimulate collaborative thinking and action, piloting new ways of working to build mutual reliance, and facilitating early and timely identification of emerging public health crises that intersect with medical regulatory authorities as below.
Current ICMRA Working Groups
1) Governance
2) Mapping
3) Communications/Outreach
4) GMP Inspections
5) Generic Medicines
6) Rapid Sharing of Information
7) Capacity Building
Indeed, much of ICMRA’s true potential is in its ability to maintain a consistent and open dialogue among the heads of MRAs, enabling them to quickly connect on issues of mutual priority or concern. A good example of this coordinated response is the September 4, 2014 ICMRA Statement on Ebola.
The ICMRA is currently operating in an interim period (2013-2015) as it builds a strong foundation for governance and sustainable collaboration. It is supported by a Secretariat and guided by a Chair, two Vice-Chairs, and a Management Committee. Membership, currently envisioned by a small number of current members emanating from earlier heads of medicines summits, will be voluntary and will include regulatory authorities for medicinal products.

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