PMDA’s Vision for Horizon Scanning of Emerging Technologies Potentially Relevant to the Development of New Medical Products: The Regulatory Challenge

Shimokawa, Masafumi; Sato, Daisaku; Wakao, Rika; Arai, Hiroyuki

doi:10.1002/cpt.1986

Cited by 6 publications

(6 citation statements)

References 5 publications

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“…These and other emerging types of therapeutics challenge current regulatory practices and regulators are responding by using horizon scanning to be more alert to the new technologies coming through development to ensure they can meet expertise gaps in the regulation of these technologies (15,(57)(58)(59). Independent horizon-scanning groups are also developing to support regulatory and policy development such as the Innovation Observatory, which is a national horizon scanning facility funded by the National Institute for Health Research in the UK.…”

Section: Evolving Therapeutic Landscapementioning

confidence: 99%

Future directions in regulatory affairs

Chisholm

Critchley²

2023

Front. Med.

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The field of regulatory affairs deals with the regulatory requirements for marketing authorization of therapeutic products. This field is facing a myriad of forces impacting all aspects of the development, regulation and value proposition of new therapeutic products. Changes in global megatrends, such as geopolitical shifts and the rise of the green economy, have emphasized the importance of manufacturing and supply chain security, and reducing the environmental impacts of product development. Rapid changes due to advances in science, digital disruption, a renewed focus on the centrality of the patient in all stages of therapeutic product development and greater collaboration between national regulatory authorities have been accelerated by the COVID-19 pandemic. This article will discuss the various trends that are impacting the development of new therapies for alleviating disease and how these trends therefore impact on the role of the regulatory affairs professional. We discuss some of the challenges and provide insights for the regulatory professional to remain at the forefront of these trends and prepare for their impacts on their work.

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Section: Evolving Therapeutic Landscapementioning

confidence: 99%

Future directions in regulatory affairs

Chisholm

Critchley²

2023

Front. Med.

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“…This foresight facilitates the creation of specific guidelines or legislation, ensuring that all innovations are well addressed within their applicable regulatory framework. The objective is to establish expertise in advance of evaluating forthcoming innovative products, thereby streamlining their path to market by minimizing potential developmental, legal or regulatory bottlenecks ( 12 ).…”

Section: Introductionmentioning

confidence: 99%

Implementing Horizon Scanning as a tool for the strategic development of regulatory guidelines for nanotechnology-enabled health products

Rodríguez-Gómez,

Monferrer,

Penon

et al. 2024

Front. Med.

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Strategic regulatory development is essential to ensure that new innovations in nanotechnology-enabled health products (NHPs) successfully reach the market and benefit patients. Currently, the lack of specific regulatory guidelines for NHPs is considered one of the primary causes of the so-called “valley of death” in these products, impacting both current and future advancements. In this study, we have implemented a methodology to anticipate key trends in NHP development and compare them with the current regulatory landscape applicable to NHPs. This methodology relies on Horizon Scanning, a tool commonly used by policymakers to foresee future needs and proactively shape a regulatory framework tailored to those needs. Through the application of this methodology, different trends in NHP have been identified, notably NHPs for drug delivery and dental applications. Furthermore, the most disruptive elements involve NHPs that are multicomposite and multifunctional, harnessing nano-scale properties to combine therapeutic and diagnostic purposes within a single product. When compared with the regulatory landscape, current regulations are gradually adapting to accommodate emerging trends, with specific guidelines being developed. However, for the most disruptive elements, multicomposite and multifunctional NHPs, their novelty still poses significant regulatory challenges, requiring a strategic development of guidelines by regulatory agencies to ensure their safe and effective integration into healthcare practices. This study underscores the importance of proactive regulatory planning to bridge the gap between NHP innovation and market implementation.

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“…Notably, new classes of therapeutics of unprecedented modality represent a regulatory challenge owing to the gaps in our knowledge. To accommodate emerging technologies, the Pharmaceuticals and Medical Devices Agency (PMDA) introduced “horizon scanning,” which involves systematic information gathering followed by activity prioritization ( 1 ). For the high-impact technologies that are difficult to assess under the existing regulatory standards, the PMDA Science Board, a committee of external experts, sheds light on significant points for the relevant area to ensure an optimal review and appropriate regulation ( 2 ).…”

Section: Introductionmentioning

confidence: 99%