Therefore, in order to simplify the procedures for the submission of an application dossier for the authorisation of a clinical trial, the multiple submission of largely identical information should be avoided and replaced by the submission of one application dossier to all the Member States concerned through a single submission portal.
Given that clinical trials carried out in a single Member State are equally important to European clinical research, the application dossier for such clinical trials should also be submitted through that single portal.
This concept should be maintained in order to ensure that timelines are adhered to.
In the event of a public health crisis, Member States should have the possibility to assess and authorise a clinical trial application swiftly.
This is particularly the case where the investigational medicinal product is covered by a marketing authorisation, that is the quality, safety and efficacy has already been assessed in the course of the marketing authorisation procedure" or, if that product is not used in accordance with the terms of the marketing authorisation, that use is evidence- based and supported by published scientific evidence on the safety and efficacy of that product, and the intervention poses only very limited additional risk to the subject compared to normal clinical practice.
Those low-intervention clinical trials are often of crucial importance for assessing standard treatments and diagnoses, thereby optimising the use of medicinal products and thus contributing to a high level of public health.
Member States should efficiently assess all clinical trials applications within the given timelines.
Scientific development, however, suggests that future clinical trials will target more specific patient populations, such as subgroups identified through genomic information.The timelines for assessing an application dossier for clinical trials should be sufficient to assess the file while, at the same time, ensuring quick access to new, innovative treatments and ensuring that the Union remains an attractive place for conducting clinical trials.Against this background, Directive 2001/20/EC introduced the concept of tacit authorisation.As regards Directive 2001/20/EC, experience also indicates that the legal form of a Regulation would present advantages for sponsors and investigators, for example in the context of clinical trials taking place in more than one Member State, since they will be able to rely on its provisions directly, but also in the context of safety reporting and labelling of investigational medicinal products.Divergences of approach among different Member States will be therefore kept to a minimum.Moreover, it should be ensured that, within the extension period, there is always sufficient time for assessing the additional information submitted.