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 (Text with EEA relevance) (2024)
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 (Text with EEA relevance)
There are currently no known outstanding effects for the Regulation (EU) No 536/2014 of the European Parliament and of the Council, Article 38.
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Article 38U.K.Temporary halt or early termination by the sponsor for reasons of subject safety
1.For the purposes of this Regulation, the temporary halt or early termination of a clinical trial for reasons of a change of the benefit-risk balance shall be notified to the Member States concerned through the EU portal.
That notification shall be made without undue delay but not later than in 15 days of the date of the temporary halt or early termination. It shall include the reasons for such action and specify follow-up measures.
2.The restart of the clinical trial following a temporary halt as referred to in paragraph 1 shall be deemed to be a substantial modification subject to the authorisation procedure laid down in Chapter III.
It introduces an authorisation procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements.
On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No.2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU until the Regulation's entry into application.
Article 58Archiving of the clinical trial master file
Unless other Union law requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial.
Products that physically combine a medicinal product or medical substance with a medical device fall either within the scope of the MDR or the EU Clinical Trial Regulation (CTR). The intended function of the medical device determines whether the MDR or CTR applies.
Regulation 536/2014 will replace Directive 2001/20/EC. For clinical trials with medicinal products it is important that the rights, safety, dignity and well-being of the subjects are protected and that the trial data are complete and reliable.
On 31 January 2022, the new Clinical Trial Regulation (CTR) entered into force. The new regulation requires that all clinical trial applications and assessments be managed through a new, unified online portal known as the Clinical Trial Information System (CTIS).
On 4 April 2001, the European Parliament and Council enacted Directive 2001/20/EC, which had to be implemented in the national law of the European Union member states by May 2004. Its aim was to improve the quality of clinical trials and to assure the safety and well-being of trial subjects.
The CTR replaces Directive 2001/20/EC, the first EU-wide legislation for clinical trials of medicinal products which applied from 01 May 2004. In the EU, legal texts called “directives” are not immediately applicable.
Article 58 of Regulation 726/2004 allows for testing of immunological medicinal product or a medicinal product derived from human blood or plasma by an OMCL in the European Community for the purpose of batch release by a third country at the recommendation of the EMEA and in cooperation with the WHO.
Unlike the CTD , EU CTR is binding in its entirety and is applicable in EU/EEA Member States: the 27 EU countries listed above as well as Iceland, Liechtenstein and Norway. The United Kingdom does not fall under EU CTR following Brexit.
One of the main differences between the EU medical device regulation and the FDA is that a clinical evaluation must be performed for all medical devices, no matter the class. As risk increases, so do requirements. Higher risk devices do require clinical investigations (tests on humans) in both markets.
The EU MDR came into force on May 26, 2021. The regulation places restrictions and reporting requirements on substances used in the design and manufacture of medical devices, excluding IV medical devices, in order to reduce the potential risks posed by some 2,000 substances.
The new EU audit legislation (Regulation (EU) No 537/2014) sets out several measures to emphasize the importance of independence of auditors, including mandatory firm rotation and a list of prohibited non-audit services. The legislation also introduces new requirements on audit committees.
The Clinical Trials Information System (CTIS) supports the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission.
European Medicines Agency (EMA) : EMA is a decentralized body of the European Union, located in Amsterdam in the Netherlands. It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use in the EU.
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