On March 12, 2020, the Italian Medicines Agency (“AIFA”) has provided guidance on the management of clinical trials due to the COVID-19 emergency.  The Guidance, which is addressed to CROs, Sponsors and non-profit organizations involved in clinical trials, allows for some derogations to support them face the criticalities.  The Guidance is intended to ensure that activities related to clinical trials may still continue, despite the current situation.

The Guidance covers all the phases of clinical trials, i.e., submission of authorization requests of clinical trials; Ethics Committees’ evaluation; management of clinical trials outside investigational sites.  The Guidance also provides some exemptions from the current EU and Italian legislation, i.e., management of the Investigational Medicinal Product; closure of a clinical trial site; clinical tests; clinical trial monitoring; reimbursement of exceptional expenses; possibility for Sponsors to enter into agreements directly with specialized agencies to carry out activities related to the management of patients.  We provide further details below.

Submission of authorization requests of clinical trials

The Guidance provides for the postponement of submission of paper documentation and CD-ROM concerning authorization requests of clinical trials and substantial amendments.  It also allows the submission of authorization requests by e-mail if the trials concern the treatment of Covid-19.

Ethics Committees’ evaluations of clinical trials/substantial amendments

Ethics Committees may arrange their meetings via web-conferences and other telematics ways.

Management of clinical trials outside investigational sites

The Guidance allows conducting clinical trial activities outside of investigational sites when this is necessary to limit the risk of coronavirus infection.  In this case, Sponsors must notify a substantial amendment for immediate implementation to the competent Ethics Committee, outlining the urgency of the situation.  Furthermore, Sponsors and CROs must prepare a risk evaluation plan and implement an action plan with the purpose to minimize contacts between patients and the staff, and to avoid to overload healthcare facilities.

As we mentioned above, the Guidance also provides some exemptions from the current EU and Italian legislation.

  1. Investigational Medicinal Product. Where possible, it may be useful to supply an amount of the Investigational Medicinal Product for a period of time longer than is normally estimated.  Under these circumstances, deliveries of the medicinal product may be arranged directly to patients, upon indications of the director of the hospital pharmacy and the principal investigator.
  1. Closure of a clinical trial site. If a site is closed to the public for COVID-19 containment measures, it should be first assessed whether the clinical trial staff is able to guarantee the continuity of the trial.  If it is not the case, the trial should be temporarily suspended or patients should be transferred to the nearest active clinical trial site.
  1. Clinical tests. Hematological tests should be carried out in public health facilities.  However, private sites should be chosen only when it is the only possibility for patients’ protection.
  1. Clinical trial monitoring. Telephone contacts or videoconferences with the trial site staff are allowed provided that these are described in specific Standard Operating Procedures (“POS”) by the Sponsor/CRO and approved by the Data Protection Officer of the trial site.
  1. Exceptional expenses reimbursement. Sponsors are allowed to directly reimburse patients, in case they incur additional expenses for the implementation of urgent measures.
  1. Possibility for Sponsors to sign directly with specialized agencies to carry out activities related to the management of patients. Interestingly, in derogation from FAQ 11 of EMA’s “Q&A: Good clinical practice (GCP)”, Sponsors may enter into service agreements directly with specialized agencies or companies, g., home nursing services, to carry out activities related to the management of patients.  Such activities must be carried out under the responsibility of the principal investigator.

AIFA makes clear that the Guidance remains valid until further notice.

Finally, it should be noted that on March 20, 2020, the European Medicines Agency published guidance on the management of clinical trials due to the current healthcare emergency.  The EMA invites all the sponsors and investigators to consult the specific national legislation and guidance in place and to use them to complete the EMA’s guidance or, for specific matters, they make take priority over the EMA’s guidance.

Tags: COVID-19, European Medicines Agency, Italian Medicines Agency, management of clinical trials
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Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart…

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart holds a Ph.D. in EU and International Law and was a professor of EU law until 2013. During that time, he wrote the first-ever handbook with Cambridge University Press on “EU External Relations Law” (2014). He then transitioned to private practice, and frequently acted for the Belgian government before the EU Court of Justice (e.g. C-16/16P Belgium vs Commission). Bart joined Covington in 2016, leading some of our most consequential EU litigation proceedings (e.g. C-311/18 “Schrems II”) over the years.  Having handled nearly 50 cases before the EU Court, he’s uniquely qualified to support our corporate clients in our most high-stakes disputes. Recent examples include T-189/21 Aloe Vera of Europe v Commission (which we won, so the Commission decided to appeal); as well as T-201/21 Covington & Burling and Van Vooren v Commission (which we also won, and hence is also on appeal).

As a pioneer in biodiversity law, over the past 15 years Bart has built a unique, global practice on Access and Benefit-Sharing (ABS) laws under the Convention on Biological Diversity, the Nagoya Protocol, the Plant Treaty, the High Seas Treaty and the WHO Pandemic Agreement. ABS compliance is critical when sourcing biological materials for life sciences R&D and I work with many of the world’s innovative life sciences companies on the whole range of e.g. transactional, contractual, compliance, IP, (EU) regulatory and litigation work relating to ABS. As biodiversity has increasingly become identified as a major commercial and financial risk to companies, so has the practice expanded to e.g. biodiversity credit markets, biodiversity insurance, biodiversity claims and advertising, and so on. Since April 2025, Bart has been appointed as the industry representative to the Steering Committee of the UN Biodiversity Fund that seeks funding from the private sector for biodiversity conservation and restoration.

Bart also pioneered our global health practice. He has advised pharmaceutical clients on seasonal and pandemic influenza since 2016. Since then, this practice area expanded to cover all matters relating to infectious diseases, and as of 2020, emergency preparedness and response (eg. WHO prequalification, International Coordination Group negotiations, Emergency Use Listing, International Health Regulations Rev 2024). He has been the pharmaceutical industry’s lead lawyer advising on the WHO Pandemic Treaty negotiations, adopted on 14 May 2025. Currently, he continues to advise on the work of the Intergovernmental Working Group (“IGWG”) teasing out the technical details of the “Pathogen Access and Benefit-Sharing System” intended to create legally binding obligations on companies to commit vaccines, therapeutics and diagnostics in case of a new global health emergency.

In Chambers rankings, clients have kindly described Bart as “very knowledgeable, action-focused and service-focused lawyer”, adding that he “really tries to find a way of working through challenges”, am “customer-oriented” and provide “sound advice and reasonable options for our business with pros and cons.”

Finally, Bart has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation before the EU Court.

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