A recurring appointment of our blog: we see below the main regulatory updates in the clinical field, published and made effective from November 2020.

AIFA: publication of documentation and ways to harmonise clinical trials start-up processes (MD related)

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.

EMA: clarification regarding the responsibilities of Sponsor and CRO in the management of a clinical trial

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”.

FDA: publication of a guidance document that aims to support the sponsor in enlisting those patient populations usually underrepresented in clinical trials.

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.