At its meeting on 1 July 2020, the Federal Council adopted the revision of the Ordinance on Medical Devices (MepV) and the new Ordinance on Clinical Trials for Medical Devices (KlinV-Mep). 

Due to the coronavirus pandemic, the European Commission has postponed the entry into force of the new European Medical Device Regulation. For reasons of coherence, the entry into force of the new provisions in Switzerland will be carried out gradually. Only the deviating regulations will come into force on 1 August 2020.

Read more about the topic (in German or French) at www.bag.admin.ch.

Researchers in Switzerland are working hard to improve the clinical and public health response to the COVID-19 pandemic. The Swiss National Science Foundation’s (SNSF) COVID-19 project database provides the public with a snapshot of these efforts.

Covid-19 project database
 

The SNSF funds 36 new coronavirus research projects

As the coronavirus pandemic began to take hold, the SNSF took swift action by launching a special call on coronaviruses on 6 March 2020. The call was enthusiastically received in the research community. Under this special call on coronaviruses, the societal and biomedical aspects of epidemics will be investigated with a total budget of 10 million francs. The projects will start as of 1 June 2020.

SNSF website: Special call on coronaviruses

All Clinical Trial Units (CTUs) of our member institutions are currently working at full speed to support research activities related to the COVID-19 outbreak.

A summary of current activities of the individual CTUs can be found under COVID-19.

Overview of submitted clinical trials and research projects

A list of submitted but not yet approved clinical trials and research projects on COVID-19 in Switzerland is available at swissethics.ch.

The latest updates on the COVID-19 pandemic from the European Medicines Agency (EMA), including all news and press releases, are available at www.ema.europa.eu.

Although the scientific community has responded to the COVID-19 challenge in an unprecedented manner, there are concerns about the growing number of COVID-19 stand-alone clinical trials with a small number of participants and observational studies, which might not generate the data required for regulatory decision-making.

In an article published on 15 May 2020 in Clinical Pharmacology & Therapeutics, EMA authors have therefore set out concrete actions that stakeholders involved with COVID-19 clinical trials should take to generate the type of conclusive evidence needed to enable rapid development and approval of potential treatments and vaccines against COVID-19.

EMA press release

Article "Clinical trials for Covid‐19: can we better use the short window of opportunity?"

As researchers race to develop vaccines and therapeutics against COVID-19, EMA has published an overview of how the Agency will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible.

The rapid procedures described in EMA's inventory include:

• Rapid scientific advice, through which developers can receive prompt guidance and direction on the best methods and study designs to generate robust data on how well a medicine or vaccine works, how safe it is, as well as on the manufacturing and control process to establish its quality. In the context of COVID-19, fees for scientific advice are waived and the procedure is reduced to a maximum of 20 days, compared to normally 40-70 days.

• Rapid agreement of paediatric investigation plans (PIPs) and rapid compliance check: The total review time for a PIP for COVID-19 products will be reduced to 20 days, compared to normally up to 120 days active review time. In case needed, EMA also carries out a check to ensure companies comply with the agreed measures listed in each PIP before a marketing authorisation can be submitted, which will now also be reduced to 4 days.

Read more in EMA's press release published on 4 May 2020

Furthermore, ECRIN established a COVID-19 Taskforce to manage and deploy tools and services to help the scientific research on COVID-19. 

Visit https://www.ecrin.org/covid-19-taskforce

The updated joint doucument by Swissmedic and swissethics describing the most important recommendations for the treatment of patients in clinical trials of medicinal products is available under:

Joint Guidance of Swissmedic and swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic (Version 2.1, 07.04.2020)

In early April, the European Commission adopted a proposal to postpone by one year the date of application of the Medical Devices Regulation to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic.

Commission postpones Medical Devices Regulation

Very comprehensive repository of recommendations and guidances from regulatory authorities and others concerning clinical trials in relation to COVID-19:

https://efgcp-events.eu/Clinical-Trials-COVID19-Repository.php

The World Health Organization (WHO) announced a large global trial, called SOLIDARITY, to test four existing treatments on their potential for drug repurposing to treat COVID-19. Read the full Science magazine article WHO launches global megatrial of the four most promising coronavirus treatments.

The spread of the new coronavirus (SARS-CoV-2) also poses a major challenge for clinical trials of medicinal products in Switzerland. Swissmedic and swissethics have therefore published a joint document, which describes the most important recommendations for the treatment of patients in clinical trials of medicinal products.

Joint Guidance of Swissmedic and swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic

EMA’s Human Medicines Committee (CHMP) has published Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials, first published on 25 March 2020.

Until April 19, CEPI is seeking to identify entities that could serve as sponsors or provide clinical research organisation (CRO) support for clinical trials of COVID-19 vaccines.
More details can be found in CEPI's call for Expression of Interest, pdf.

For the sixth time, the ​Swiss National Science Foundation (SNSF) is launching a call for clinical studies on topics that are outside the industry focus.

NEW: Applicants must submit a letter of intent (LOI) for the first time via mySNF by 26 May 2020. The platform will be open to researchers as of 1 April 2020.

Participation requirements Investigator Initiated Clinical Trials (IICT)

For older news please see our news archives 2019, 2018, 2017, 2016, 2015, 2014 and 2013.