The International Coalition of Medicines Regulatory Authorities (ICMRA) have released a report which outlines how regulators worldwide are working together to identify and address future regulatory challenges posed by new categories of therapeutics, such as cell and gene therapies, and new tools for drug development, including artificial intelligence. Singapore, Japanese and European drug regulators also discussed topics such as additive manufacturing and genome editing.
The report is part of a wider effort to decrease duplicative work and increase harmonisation among medicines regulators from the United States (US), Europe, Japan and elsewhere. The report discusses the topic of horizon scanning for new innovations and addresses novel regulatory pathways, for example expedited pathways and those related to early engagement with stakeholders, such as Health Technology Assessment agencies.
The report states that “the pace of innovation in medical devices has surpassed medicines due to 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 reports also adds that “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”.
Drug regulators will need to ensure staff are trained on new product types, and have access to outside experts such as software engineers, who will also require regulatory training.
To read the innovation strategic project report, please click here.