32014R0536

WHAT IS THE AIM OF THE REGULATION?

• The regulation aims to simplify and speed up procedures authorising clinical trials to ensure that the European Union (EU) remains an attractive centre for clinical research. It also aims to foster multinational clinical trials conducted both by commercial and non-commercial entities to deliver innovative medicines to patients and improve treatments using existing medicines.
• It repeals Directive 2001/20/EC, but a transition period is in place until 31 January 2025 (see section ‘From when does the regulation apply?’ below).

KEY POINTS

General principle

A clinical trial may be held only if:

• the rights, safety, dignity and well-being of participants are protected and prevail over all other interests; and
• it is designed to generate reliable and robust data.

Rules

1. Less bureaucracy (‘red tape’). Sponsors of clinical trials will only need to submit a single application for approval irrespective of where in the EU the trial is to be held. There will be less red tape.
2. Shorter authorisation times. The timeline to authorise clinical trials is set at 60 days. If no decision is taken within this period, the trial may go ahead (‘tacit approval’). Decisions on applications for substantial modifications of clinical trials must be taken within 49 days. Where no decision is issued, the authorisation is considered to be given.
3. Vulnerable groups. Applications for the authorisation of clinical trials must be assessed on the basis of appropriate expertise. Specific expertise must be used to assess clinical trials involving participants in emergency situations, minors, those who are incapacitated, pregnant and breast-feeding women and, where appropriate, certain other groups, such as older people or those suffering from rare and extremely rare diseases.
4. Ethical review. All trials are subject to scientific and ethical review. The ethical review must be performed by an ethics committee in accordance with the law of the EU Member State concerned. However, the procedures and the timelines for the ethical review must be compatible with the authorisation procedure stipulated by this regulation.
5. Informed consent. Prior to the trial, participants must be given clear information about their rights (including the right to withdraw); conditions, duration, nature, objectives, implications, risks and inconveniences of the trial; possible treatment alternatives; and the possible damage compensation system.
6. Publicly accessible EU database on clinical trials. The European Medicines Agency set up a database named Clinical Trial Information System containing information on all clinical trials held in the EU, whether successful or not.
7. Safety assessments. The cooperation between Member States in the assessment of safety information reinforces clinical trials in generating high quality data and improves the safety of current and future medicines on the EU market. An implementing act, Implementing Regulation (EU) 2022/20, sets out the rules for cooperation between Member States when assessing safety information reported in accordance with Regulation (EU) No 536/2014.
8. Member State inspections. Member States must appoint inspectors to supervise compliance with the regulation and ensure that those inspectors are adequately qualified and trained. Implementing Regulation (EU) 2017/556 sets out the detailed arrangements for good clinical practice inspection procedures.

FROM WHEN DOES THE REGULATION APPLY?

Regulation (EU) No 536/2014 has applied since 31 January 2022, 6 months after the publication of the notice referred to in Article 82(3) stating that an independent audit report verified that the EU portal and the EU database have achieved full functionality (see Decision (EU) 2021/1240). The existing legislation in the field (Directive 2001/20/EC) will be repealed following a 3-year transition period from that date.

BACKGROUND

The Commission’s former good manufacturing practice directive has been repealed by the new Commission good manufacturing practice directive, Directive 2017/1572, on the date of entry into application of the regulation on clinical trials.

The guidelines for the application of clinical trials directive can be found in EudraLex, Volume 10.

For further information, see:

• Clinical trials (European Commission).

MAIN DOCUMENT

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, pp. 1–76).

Successive amendments to Regulation (EU) No 536/2014 have been incorporated into the original text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (OJ L 5, 10.1.2022, pp. 14–25).

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 Regulation (EU) No 536/2014 of the European Parliament and of the Council (OJ L 275, 31.7.2021, pp. 1–2).

Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council (OJ L 80, 25.3.2017, pp. 7–13).

Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use OJ L 238, 16.9.2017, pp. 44–50)

Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (OJ L 238, 16.9.2017, pp. 12–21).

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, pp. 34–44).

See consolidated version.