New European Regulation for Clinical Trials of Medicinal Products

2015 ◽  
Vol 191 (1) ◽  
pp. 16-18 ◽  
Author(s):  
François Lemaire ◽  
Mihaela Matei ◽  
Philippe Juvin
Keyword(s):  
Clinical Trials ◽  
Medicinal Products ◽  
European Regulation

scholarly journals Defining the Threshold of Permissible Risk for Non-therapeutic Clinical Trials with Children in Europe

2017 ◽  
Vol 24 (4) ◽  
pp. 414-431
Author(s):  
Katherine Wade*
Keyword(s):  
Clinical Trials ◽  
Medical Care ◽  
Medicinal Products ◽  
Council Of Europe ◽  
Therapeutic Trials ◽  
Research With Children ◽  
Individual Trial ◽  
The One ◽  
Definition Of ◽  
Trial Participants

Abstract It is important that clinical research with children is encouraged so that they are not exposed to the dangers of extrapolation from adult treatments. Clinical trials with investigational medicinal products (imps) are an important part of improving medical care for children. Both the 2001 Clinical Trials Directive and the 2014 Regulation recognise the need for such research, including the need for non-therapeutic trials with imps. However, it is also recognised that a balance must be struck between permitting tailored medical care for children as a group on the one hand, and protecting individual trial participants from harm on the other. A central issue in striking this balance relates to defining the threshold of risk which should be permitted in such research. This article provides a critical analysis of the current European law in relation to the definition of acceptable risk for non-therapeutic clinical trials with imps and makes recommendations for reform, drawing on law from the Council of Europe, as well as law from the us.

scholarly journals EMEA and Gene Therapy Medicinal Products Development in the European Union

2003 ◽  
Vol 2003 (1) ◽  
pp. 3-8 ◽  
Author(s):  
Marisa Papaluca Amati ◽  
Francesco Pignatti ◽  
Alexis Nolte ◽  
Nirosha Amerasinghe ◽  
Daniel Gustafsson ◽  
...  
Keyword(s):  
Gene Therapy ◽  
European Union ◽  
Clinical Trials ◽  
Good Clinical Practice ◽  
Evaluation Agency ◽  
The European Union ◽  
Medicinal Products ◽  
Regulatory Processes ◽  
National Competent Authorities ◽  
Practice Implementation

The evaluation of quality, safety, and efficacy of medicinal products by the European Medicines Evaluation Agency (EMEA) via the centralized procedure is the only available regulatory procedure for obtaining marketing authorization for gene therapy (GT) medicinal products in the European Union. The responsibility for the authorization of clinical trials remains with the national competent authorities (NCA) acting in a harmonized framework from the scientific viewpoint. With the entry into force of a new directive on good clinical practice implementation in clinical trials as of 1 May 2004, procedural aspects will also be harmonized at EU level. Scientifically sound development of medicinal products is the key for the successful registration of dossiers and for contributing to the promotion and protection of public health. The objective of this paper is to introduce the EMEA regulatory processes and scientific activities relevant to GT medicinal products.

The Proposed EU-regulation on Clinical Trials on Medicinal Products: An Unethical Proposal?

2013 ◽  
Vol 20 (4) ◽  
pp. 347-362 ◽  
Author(s):  
Jilles Heringa ◽  
Joseph Dute
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
The European Union ◽  
Medicinal Products ◽  
Member States ◽  
Legal Documents ◽  
Human Use ◽  
Proposed Regulation ◽  
High Level ◽  
Force Member

Abstract The Commission has proposed a regulation ‘on clinical trials on medicinal products for human use’ to introduce one regulatory framework for clinical trials in the European Union. This regulation should replace the current clinical trials directive (2001/20/EC). In this article we describe and critically review the main provisions of the proposed regulation. We assess the consequences for a sound authorisation procedure of clinical trials and the level of protection for human subjects. We note that the proposed regulation is inconsistent with applicable international legal documents, such as the Biomedicine Convention and the Declaration of Helsinki. We conclude that the proposed regulation does not ensure a “high level of human health protection” — required by its legal basis in the TFEU — because it may force Member States concerned to accept a reporting Member States’ approval of — in their estimation — an unethical clinical trial.

INDUSTRIAL ACTIVITY REVIEW OF THE FRENCH NETWORK OF PEDIATRIC CLINICAL INVESTIGATION CENTERS (FN-PCIC) 2008–2013

2015 ◽  
Vol 101 (1) ◽  
pp. e1.27-e1
Author(s):  
Elsa Maksooud ◽  
Evelyne Jacqz-Aigrain
Keyword(s):  
Clinical Trials ◽  
Clinical Investigation ◽  
European Medicines Agency ◽  
University Hospitals ◽  
European Regulation ◽  
Clinical Investigations ◽  
Number Of Patients ◽  
Inclusion Rate ◽  
The Impact ◽  
Drug Studies

IntroductionThe French Network of Pediatric Clinical Investigations Centers (FN-PCIC) created in 2000 includes today 16 CIC grouped under the auspices of the INSERM and the corresponding public university hospitals. In response to the European pediatric regulation published in 2007, all pharmaceuticals laboratories, in order to complete their drug profile, must conduct pediatric clinical trials according to the Pediatric Clinical Investigation Plan and validated by the European Medicines Agency (EMA). This network plays a major role in facilitating and optimizing the conduction of nation-wide pediatric clinical trials. Therefore, the PN-CIC plays a major role to response to this acute demand in the pediatric field. The purpose of this review is to sum up the activity of the FN-PCIC between 2008 and 2013 and to analyze the impact of the European regulation.MethodsOnly the industrial protocols will be analyzed, for every protocol a certain number of information was collected such as the pharmaceutical industry, the therapeutic fields, the phase of the study, the duration of the study, the methodology, and the number of patients needed.Results261 protocols were active during this period by 90 different sponsors. 218 were interventional studies and 43 were observational or non-drug studies (registers, post-AMM). The number of active studies was at 127 in 2013 compared to 76 in 2008. Furthermore, the total number of participations were 242 for 16 CIC in 2013 compared to 110 in 2008. The mean inclusion rate was 87%. The percentage of the common studies rises from 36% in 2008 to 50% in 2013. In addition, the feasibility study demands increased and were as high as 57, an average of one demand per week The inclusion percentage calculated using the data of the closed studies is at 87%. The therapeutic fields concerned were nephrology and oncology (15%), then neurology and pneumology (13%).ConclusionActivity increased, linked to the national coverage now including 16 centers and high quality procedures to perform pediatric research trials under high ethical and quality standards.

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