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
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“.
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”