A recurring appointment of our blog: we see below the main regulatory updates in the clinical field, published in the months between November 2020 and February 2021

AIFA: publication of documentation and ways to harmonise clinical trials start-up processes (MD related). New indications on the submission of requests for clinical trials for Covid-19 and formalization of data on clinical trials of medicines in Italy in 2020

Among the many consequences of the health crisis since Covid 19, we also find the postponement of the entry into force of the European Regulation 2017/745. Expected for many years, it was released in May 2017. From that date it entered into force with the aim of reaching its full application from May 2020. The current health emergency, however, has delayed this date by one year, the regulation on medical devices should become operational in May 2021.
At this stage of passage, AIFA has published a series of documents with the aim of providing Ethics Committees and Health Companies with a useful tool to promote harmonisation in the approval and launch processes of research projects and helping to reduce unnecessary delays. As of November 2020, the English version of the “Contract for the conduct of the Clinical Profit Medical Device Survey” has been made available.
AIFA publishes the “19 National Report on Clinical Trials of Medicines in Italy 2020“, which provides a periodic update on the qualitative and quantitative performance of clinical research in Italy.
AIFA shall notify the publication of certain indications regarding submission of clinical trial requests for COVID-19, with the aim of limiting the number of cases in which, for a given clinical trial, the number of patients initially planned or even the recruitment phase cannot be enrolled

EMA: clarification regarding the responsibilities of Sponsor and CRO in the management of a clinical trial. Publication of the newsletter of Dicember and documentation that supports pediatric clinical trials in Europe.

We communicate the update by EMA of the internet page “Q&A: Good clinical practice (GCP)”. In particular, the November 2020 update concerns question 14 of the “GCP matters” section: “14. Does the sponsor of a clinical trial have the right to audit the manufacturer of the IMP even if the manufacturer has been subcontracted by a CRO involved in a clinical trial?”. The application clarifies that the sponsor, as responsible for the quality of the IMP and the implementation of the Quality Management System, is authorized to audit the manufacturer even when certain services have been subcontracted to a CRO.
In addition, we also note the publication by EMA of the template/form: “Day 80 assessment report – Clinical template with guidance rev.02.20”.

Notice is given of the publication by EMA of the newsletter “Clinical Trials Information System (CTIS) highlights – December 2020.

We note the publication by EMA of the document “Assent / Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe“, which provides an overview of the contents of the consent/informed consent forms for all interested parties (as patients, sponsors, researchers) to support the conduct of paediatric clinical trials in Europe.

FDA: publication of a guidance document that aims to support the sponsor in enlisting those patient populations usually underrepresented in clinical trials. Update of the document “Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”

We notify the publication by the FDA of the document Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. This guidance document aims to guide sponsors of clinical trials to support an application for a new drug or for a new biologist to increase the recruitment of under-represented populations in their clinical trials.
We share the FDA’s release of updates to the document “Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency“, useful to ensure the safety of participants in clinical trials of medical products and to answer questions received on conducting clinical trials during the health emergency COVID-19.