Strategic Priority on Innovation – ICMRA Innovation Project 3D Bio-Printing Case Study: Summary of Discussions and Considerations for the New Informal Innovation Network
October 1, 2019
The International Coalition of Medicines Regulatory Authorities (ICMRA) Innovation Project identified 3D printing, artificial intelligence and gene editing as emerging disruptive technologies that challenge traditional health product regulatory systems. In an attempt to identify novel regulatory approaches to license health products manufactured or developed through these technologies, the Innovation Project team launched a case study on 3D bio-printing. Health Canada led these discussions with the following ICMRA members participating: the Therapeutic Goods Administration (TGA) of Australia; the Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil; the European Medicines Agency (EMA) of the European Union; the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency (MHLW/PMDA) of Japan; and the Health Sciences Authority (HSA) of Singapore.
From a public health, biotechnology and tissue engineering perspective, engineered therapies for musculoskeletal and vascular applications are advancing to address patient treatment demands. A hypothetical 3D bio-printed human knee meniscus was chosen for this case study, based on the current developments seen in the field and in the literature. The goals of the case study were to better understand key challenges for regulating this product, identify emerging regulatory solutions, and suggest areas for further scientific and policy discussions.
There are many components of 3D bio-printing that could require regulatory oversight. These may include the printer itself, software, production processes, living and non-living printing material, and the deployment of the technology. 3D bio-printing technology challenges regulators with respect to classification of the output, and regulating different models of manufacturing (centralized model versus point-of-care production).
For this 3D bio-printing case study, agencies suggested that standards could be used to support regulatory processes. Standards would be especially important for the point-of-care production model of 3D bio-printing, although it was acknowledged that they have thus far been established only for centralized production settings. There would be a need to review standards to address specific aspects pertaining to the point-of-care production model.
Agencies called for risk-based oversight that combines regulatory requirements that are “fit for purpose”, so that quality evidence can be generated to support short-term and long-term product safety and efficacy. Other suggestions by agencies included fostering regulator capacity building to fill the knowledge gaps, engaging with other regulatory authorities and stakeholders to mitigate uncertainties, and clarifying the roles and responsibilities of regulators vis-à-vis stakeholders.
Throughout the discussions, agencies suggested regulatory approaches that were highly convergent. Agencies agreed to the importance of product risk management plans and maintaining product registries for traceability. Three out of the six agencies reported that they were developing new regulatory frameworks (i.e., ANVISA and HSA) or implementing new legislation (i.e., Health Canada) aimed at facilitating innovative product development. 3D bio-printed products would be addressed in these new frameworks/legislation.
The agencies concluded that certain new approaches and challenges that would require further discussion among regulators could continue as part of the newly established ICMRA informal Innovation Network.
Disclaimer: This report reflects the outcome of an exercise based on a hypothetical product, and none of the content of the report should be taken as the regulatory thinking or position of any of the ICMRA members.
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:
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.