Drug Regulators Look to Harmonize How They Tackle Innovation

Regulatory NewsRegulatory News | 21 May 2019 |  By 

The International Coalition of Medicines Regulatory Authorities (ICMRA) recently released a report on how various regulators worldwide are working together to better identify and address future regulatory challenges posed by new categories of therapeutics, like cell and gene therapies, and new tools for drug development, such as artificial intelligence (AI).

The report, which is part of a wider effort to reduce duplicative work and increase harmonization among drug regulators from the US, Europe, Japan and elsewhere, delves into the topic of horizon scanning for new innovations, which for most regulators is “still in its infancy.” The report also addresses novel regulatory pathways, such as expedited pathways, and others related to early engagement with stakeholders, such as Health Technology Assessment agencies.

“The pace of innovation in medical devices has surpassed medicines due adaptable approaches to the regulation of innovative products. While the existing novel licencing pathways for medicines have seen positive results in providing timely patient access, current and upcoming innovations will continue to challenge regulators,” the report notes.

European, Japanese and Singapore drug regulators also further explored the topics of additive manufacturing, genome editing and AI.

“The products and technologies explored in the case studies show that many regulatory science tools are missing at present (e.g. off-target effects detection methods) and must be developed in order for regulators to be able to assess the products across their life-cycle. In addition, new technologies (such as additive manufacturing) require adaptation of the existing regulatory frameworks, as they facilitate the production of more complex products at the point of care rather than in dedicated manufacturing sites,” the report adds.

Regulators will need to train staffers on the new product types, but will also have to access outside experts (e.g., software engineers), who will require regulatory training, as well. The agencies proposed developing a capacity framework for expertise as a common resource, featuring the mapping of the required skills and expertise for various types of products or technologies to assist regulators in identifying their capacity needs.

ICMRA, which is also looking to establish an informal innovation network among ICMRA members later this year, will seek to better articulate the common characteristics of novel regulatory pathways and to assist the analyses and considerations of new and existing regulatory methods.

In addition to the strategic priority project report on innovation, ICMRA recently released a framework for the involvement of health authorities in the management of global health crises.

Innovation Strategic Priority Project Report


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