Strategic Priority on Innovation – Final Report and Statement

April 24, 2019 

In the ever-changing regulatory landscape, new products, technologies, and production models are constantly challenging existing regulatory frameworks. In response to this, regulators are reviewing their approaches to find ways to enhance and creatively use existing methods, as well as exploring new regulatory tools to facilitate safe and timely access to innovative health products. While the existing novel licensing pathways have seen positive results in providing timely patient access, the ongoing wave of innovations will continue to challenge regulators. It is necessary for regulators to explore new approaches in order to provide adaptive as well as comprehensive regulatory oversight, facilitating the timely approval of novel medicines and technologies while at the same time protecting public health.

In order to enhance our understanding of the approaches being taken among regulators to address the challenges in the area of innovation, ICMRA adopted Innovation as a new Strategic Priority in 2017. An Innovation project framework was established and ICRMA members undertook research and analysis focusing on three themes which included:

Workstream 1 (WS1) analysis of global best practice in horizon scanning
Workstream 2 (WS2) leveraging outcomes of horizon scanning
Workstream 3 (WS3) novel approaches to licensing

The ICMRA Innovation project reviewed horizon scanning methodologies being used to identify innovative products and regulatory trends and assessed how regulators can effectively benefit from the outcomes of horizon scanning. Novel regulatory pathways currently in place, which provide frameworks for the regulation of disruptive innovative products, were also examined. The challenges at each stage of the process were identified, which formed the basis of recommendations for how ICMRA can play a strategic role in addressing some of the prominent issues in the evolving regulatory landscape.

The initial project phase of the Innovation Strategic Priority has concluded with the report presented here, which outlines activities undertaken by the three work streams. The following recommendations were agreed upon by the members:

• The establishment of an Innovation network within ICMRA
• The development of a capacity framework for expertise required for regulation in the future
• An Innovation position statement on behalf of ICMRA

The next phase of work will include the establishment of an informal Innovation network among ICMRA members in mid-2019. The network will aim to build on the positive interactions during the initial project process and to explore further innovative challenges and harmonised solutions on a global level.

The report and postion statement are available below:

Innovation Project Final Report

Statement on Innovation


Strategic Priority on Innovation – Concept Note

December 11, 2017 

Innovation has been discussed as a possible new project by IMCRA since the ICMRA meeting in Interlaken, Switzerland in November 2016. To identify topics of greatest interest, ICMRA conducted a survey of its members in early 2017 to determine specific project focus areas. The members agreed on the content, including concrete themes, of the ICMRA Strategic Priority on Innovation (SPI). The SPI was formally approved and launched by ICMRA at its October 2017 meeting held in Kyoto, Japan.

To maintain transparency of ICMRA’s activities, a Concept Note was prepared to provide a brief overview of the issues the ICMRA SPI aims to address, the rationale for why ICMRA should address these issues and how ICMRA plans to add value, and the concrete work plan for the SPI.  This Concept Note has been endorsed as a formal ICMRA document.