Which objective(s) does the Commission pursue?

The aim was to ensure that Europe remains an attractive place for clinical research by providing a single set of harmonised rules. The proposal provided for:

• streamlined application procedures via a single entry point,

• single authorisation procedure for all clinical trials,

• improved conditions for conducting multinational clinical trials,

• strengthened rules on the protection of patients and informed consent,

• more transparency on the conduct and results of the clinical trial,

• possibilities for the Commission to conduct controls in Member States and third countries to ensure the rules are being properly supervised and enforced.

This is expected to:

• Facilitate the work of all actors, especially SMEs, by creating a unique set of rules applicable across Europe.

• Reduce administrative burden through the creation of a one-stop shop (submission of a single set of documents via a single portal) for the authorisation of clinical trials.

• Improve transparency and legal certainty of the authorisation process through clear rules and binding deadlines

Estimated savings and benefits

During the impact assessment process in 2012 savings were estimated as follows: an annual reduction in administrative burden of EUR 267 million and an annual reduction in compliance costs of EUR 540 million.

Outcome of Legislative Procedure

Most of the objectives have been achieved. Only the timelines for the authorisation of clinical trials have been extended compared to the initial proposal following the amendments introduced by Council which may have a small impact on the reduction of cost (positive or negative). However such a possible impact has not been assessed.

Estimated savings and benefits

Due to the limited availability of data, the estimated savings have not been updated to reflect the agreed final text.

The European Portal and Database, an IT tool which is pre-requisite for the application of the Regulation as a whole, has been under development by EMA since 2014, and has been audited by an independent organisation end of 2020, as foreseen in the Regulation itself. Subsequently, this audit was the basis for a confirmation by the EMA Management Board, which in turn informed the Commission that the European Portal and Database are fully functional. 

The Commission has published the Commission Decision (EU) 2021/1240 of 13 July 2021 on the compliance of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of the Clinical Trial Regulation, triggering a 6-month period before the applicability of the Regulation.  

Application starts from 31 January 2022. A one-year transition period will apply (Directive + Regulation), allowing submission of new clinical trial applications under the Directive or Regulation rules until 31 January 2023. Clinical trials authorised under the Directive can continue to be run according to the Directive rules until 31 January 2025.

In order to apply at the same time as the ‘Clinical Trials Regulation’, Implementing Regulation (EU) 2022/20 was adopted on 7 January 2022 (under Art 44.2) setting out the rules and procedures for Member State cooperation of safety assessment in clinical trials.

Implementation reported by Member States

The Regulation will be implemented in 2021.

Establishment in 2021 of baseline for use in subsequent evaluation.

This encompasses the collection and monitoring of data relating to the following indicators:

• Clinical trials per year, by phase and by sponsor status;

• Number of Member States involved per clinical trial per year;

• Number of subjects in clinical trials in the EU per year;

• Number of medicinal products authorised by the European Commission per year;

• Pharmaceutical R&D expenditure in Europe, USA and Japan (depending on figures given by EFPIA (European Federation of Pharmaceutical Industries and Associations).