Chapter III, Article 11 · Commission Implementing Regulation (EU) 2022/20

Contents

Article 11Information systems to support the cooperation in safety assessment#

1.The Agency, in its role of manager of the EudraVigilance database, the Clinical Trial Information System and the EU Medicinal Product Dictionary, shall provide the information systems to support the cooperation in safety assessment, covering the functionalities set out in paragraph 3.

2.The Agency, the Commission and the Member States shall evaluate the available information system support on a regular basis, at least annually, and their findings shall be duly considered in the maintenance and updating of the information systems referred to in paragraph 1.

3.The functionalities developed shall:

(a)support searchable listing of active substances contained in investigational medicinal products used in clinical trials that have been authorised in Member States concerned under Regulation (EU) No 536/2014;

(b)enable recording of the safety assessing Member States for a given active substance contained in investigational medicinal products, including retaining the names of previous safety assessing Member States where a new a new safety assessing Member State is appointed for the same active substance;

(c)support searchable listing of different active substances contained in investigational medicinal products used in clinical trials including the identity of the responsible safety assessing Member States for multi-national active substances, or in the case of mono-national active substances, reporting Member States;

(d)enable traceable recording and storage of the assessments of information submitted in reports on suspected unexpected serious adverse reactions and in annual safety reports;

(e)enable all Member States to access annual safety reports, reports on suspected unexpected serious adverse reactions and the assessments referred to in point (d);

(f)enable communication between Member States and between Member States and sponsors;

(g)provide information on when an annual safety report is overdue;

(h)support the screening of suspected unexpected serious adverse reactions, including the provision of predefined reports;

(i)support cooperation between Member States in the assessment of changes to the reference safety information, when required.

4.Clinical trial documentation, which is relevant for the safety assessment, shall be made available to safety assessing Member States, regardless of whether they are a Member State concerned by that clinical trial.

5.The Agency shall, together with the Member States and the Commission, develop the information systems to support the selection and re-selection procedure of the safety assessing Member State, referred to in Articles 3 and 4, by the end of the transition period as laid down in Article 98 of Regulation (EU) No 536/2014.

6.Clinical trials using the same active substance shall be identified in the information systems referred to in paragraph 1, based on the EU active substances code referred to in Article 81(3) of Regulation (EU) No 536/2014.

Defined terms · 9

Show every defined term

Lead safety assessing Member State
means the safety assessing Member State, which coordinates the safety assessments for different active substances in a clinical trial or for several clinical trials, performed by several safety assessing Member States.
Mono-national active substance
means an active substance, which is used in an investigational medicinal product in clinical trial(s) authorised in only one Member State.
Multi-national active substance
means an active substance, which is used in an investigational medicinal product in clinical trial(s) authorised in more than one Member State.
Multi-national clinical trial
means a clinical trial for which the sponsor submitted an application dossier to more than one Member State through the EU portal.
New active substance for safety cooperation
means an active substance, which has not been previously used in an investigational medicinal product in any clinical trial authorised in the Union under Regulation (EU) No 536/2014, and therefore does not have an assigned safety assessing Member State.
Reference safety information
means the safety information contained in the latest approved version of the clinical trial dossier, which serves as the basis to determine the expectedness of an adverse reaction by the sponsor.
Safety assessing Member State
means the Member State that assesses the information submitted as suspected unexpected serious adverse reactions in accordance with Article 42 of Regulation (EU) No 536/2014, and the information contained in annual safety reports submitted in accordance with Article 43 of that Regulation, for clinical trials involving investigational medicinal products that contain the same active substance, regardless of the pharmaceutical form and strength or indication investigated and regardless of whether they are used in one or several clinical trials managed by the same or different sponsors.
Safety concern in relation to an investigational medicinal product
means information on the safety of the investigational medicinal product with potential negative impact on its benefit-risk ratio or with a public health implication.
Screening of suspected unexpected serious adverse reactions
means the systematic identification of suspected unexpected serious adverse reactions that require an assessment leading to a decision on the need to notify the reporting Member States and Member States concerned.