31.1.2022
EN
Official Journal of the European Union
L 20/7
obtaining reliable evidence is through coordinated, well-designed, and adequately powered large randomised controlled trials.
Clinical trial results and clinical data produced after the relevant marketing authorisation has been granted should be made publicly available in a timely manner.
The publication of the trial protocol at the start of the clinical trial would allow public scrutiny.
(32)
Whenever necessary, considering that medicinal products for human use may impact the veterinary sector, a close liaison with the national competent authorities for veterinary medicinal products should be envisaged.
(33)
Although individual research entities may agree with each other or with another party to act as a sponsor in order to prepare a single harmonised Union-wide clinical trial protocol, experience during the COVID-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that is able to take up all the responsibilities and activities of a sponsor within the Union as well as interact with multiple Member States.
To address that problem, a new Union-wide and Union-funded vaccine trial network called VACCELERATE was launched following the Commission communication of 17 February 2021 entitled ‘HERA Incubator: Anticipating together the threat of COVID-19 variants’.
The Agency should identify and facilitate such initiatives by giving advice on the possibilities for acting as a sponsor or, where applicable, for allocating respective responsibilities as co-sponsors in accordance with Article 72 of Regulation (EU) No 536/2014 and coordinate the development of clinical trial protocols.
Such an approach would strengthen the research environment in the Union, would promote harmonisation and would avoid subsequent delays in availability of results of research for marketing authorisation files.
A Union sponsor could benefit from Union research funding available at the time of the public health emergency as well as from existing clinical trial networks to facilitate the development, application, submission, and running of trials.
This may be particularly valuable for trials established by Union or international public health or research organisations.
(34)
The Agency publishes European Public Assessment Reports (EPARs) for medicinal products authorised in accordance with Regulation (EC) No 726/2004 which provide information on the assessment of those medicinal products by describing the data assessed and the reasons for recommending whether a medicinal product should be authorised.
The EPAR includes detailed information with regard to all relevant pre-submission activities under that Regulation, including the names of the coordinators and experts involved, and, where a medicinal product developer requests scientific advice during the pre-submission phase, an overview of the scientific topics discussed in view to that advice.
(35)
With respect to medical devices, an executive steering group on shortages of medical devices should be established to coordinate urgent actions within the Union in relation to the management of supply and demand issues of medical devices, and to establish a list of critical medical devices in the case of a public health emergency (the ‘Medical Device Shortages Steering Group – MDSSG’).
To ensure such coordination, the MDSSG should also liaise with the Medical Devices Coordination Group (‘MDCG’) established by Article 103 of Regulation (EU) 2017/745 of the European Parliament and of the Council (10), where appropriate.
In that respect, Member States should be able to appoint the same representatives to both the MDSSG and the MDCG.
(36)
The operational phase of the work of the MSSG, the MDSSG and the ETF should be triggered by the recognition of a public health emergency in accordance with Decision No 1082/2013/EU of the European Parliament and of the Council (11) and, as regards the MSSG, also by the recognition of a major event.
The continuous monitoring of risks to public health from major events, including manufacturing issues, natural disasters and bioterrorism that have the potential to affect the quality, safety, efficacy, or supply of medicinal products should also be ensured.
In addition, such monitoring should follow the One Health approach.
(10) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(11) Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).