I. Reischl (Vienna, AT)

AGES MEA Clinical trials
Ilona Reischl joined the Austrian Medicines and Medical Devices Agency AGES/MEA in March 2006 and has been affiliated with the Clinical Trials Unit since then and heading the division until 2019. This division in the Institute Surveillance is responsible for clinical trials with medicinal products or medical devices and GCP inspections. After an initial degree in pharmacy; a PhD in immunology/allergology and postdoctoral experience at an industrial research institute (AT); post-doctoral positions followed at the University of Southampton (UK) and the National Institutes of Health (USA) in immunology. The current regulatory focus started with a dual research/regulatory position at the US Food and Drug Administration (FDA). Ilona Reischl is a quality assessor and the Austrian member of the European Medicines Agency Committee for Advanced Therapies and the Biologics Working Party. She is actively involved in manufacturing; procedural and scientific issues pertaining to biotech products in general and ATMPs in particular. Her regulatory expertise covers clinical trials with medicinal products and medical devices. Her particular interest is in legal and regulatory interface issues in the context of combination products and in vitro diagnostics.

Presenter Of 1 Presentation

Extended Abstract (for invited Faculty only) Others

22.1.4 - Regulatory Issues for ATMPs

Presentation Topic
Others
Date
15.04.2022
Lecture Time
09:00 - 09:15
Room
Potsdam 1
Session Type
Plenary Session

Abstract

Introduction

The outcome of the translation of basic knowledge into a clinical application is often covered by specific legislations and thus associated with regulatory requirements linked to them. Broadly speaking, legal, procedural and scientific issues need to be considered.

While scientific issues might be more globally aligned, procedural and legislative frameworks differ approaches between regions. The presentation will focus on the EU and provide considerations to ensure compliance, usability and robustness of data generated in development. In addition, innovative developments frequently bridge the interface between multiple legislations, which adds scientific and regulatory complexity to their development. With a focus on Advanced Therapy Medicinal Products (ATMPs), the presentation will give a brief overview on issues to consider and support available.

The first regulatory consideration is whether a certain development falls under the legal definition of a medicinal product, medical device or other, considering indication and mechanism of action. Procedural requirements for clinical trial submissions are revised at the beginning of 2022 with the practical application of the EU Clinical Trials Regulation (Regulation (EU) 536/2014), further information is available in EudraLex Volume 10 (https://ec.europa.eu/health/documents/eudralex/vol-10_en), where dedicated guidance is also available according to the nature of the investigational medicinal product (e.g. small molecule, biologic, ATMP). Guidance for later development stages and requirements for marketing authorization can be found on the webpage of t he European Medicines Agency (EMA, www.ema.europa.eu).

For developments incorporating device elements or codevelopment of in-vitro diagnostics, the Medical Device Regulation (Regulation (EU) 2017/745, MDR) and the In Vitro Diagnostics Regulation (Regulation (EU) 2017/746, IVDR) need to additionally be considered. Where a product has a device element, procedural requirements during development differ depending on whether the device is considered as integral or not. Intregral devices need to comply with the general performance and safety requirements of annex I of the MDR, but procedurally, a clinical trial with such a product falls under the medicines legislation only. In contrast, where a medicinal product and a non-integral medical device are being co-developed, the procedural requirements for clinical trials according to both legislations need to be considered. The latter also applies for the co-development of in-vitro diagnostics including companion diagnostics. The legislative framework currently does not provide for a single procedure investigating both medicines and medical devices/IVDs.

Efforts are ongoing to clarify interface issues between medicines and medical device legislations with guidance to follow. Guidance on the consultation procedure for Companion diagnostics has recently been published on the EMA website. Further, for cell-based approaches, the ongoing revision of the EU Tissues and Cells Legislation is to be considered for donation and procurement requirements.

Support for developers is available through the Innov ation Network, which includes Innovation offices at National Competent Authorities and EMA. In addition, scientific advice is provided on both National and EMA level, where EMA scientific advice focuses on marketing authorization requirements.

Content

The presentation will highlight regulatory requirements during early development of a biological medicinal product, give a brief guide on the regulatory system and highlight interface issues for medicinal products combining drug and device elements, including in vitro diagnostics

References

https://ec.europa.eu/health/documents/eudralex/vol-10_en

www.ema.europa.eu

www.who.int/groups/expert-committee-on-biological-standardization

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