More than a year after the outbreak of the pandemic, the COVID-19 is still the protagonist of numerous studies and with these new updates. Government agencies and regulatory agencies still work constantly to offer current releases and guidelines for the effective and safe management of clinical trials. Following the main news emerged in Italy, Europe and the USA in March and April.

EUROPEAN COMMISSION: Publication of the guideline providing the guidance on the conduct of clinical trials during the pandemic and the document providing some answers to questions related to the entry into force of Regulation (EU) No 536/2014 on clinical trials.

Notice is given by the European Commission of the publication of the guideline “Guidance On The Management Of Clinical Trials During The Covid-19 (Coronavirus) Pandemic” version 4 of 04/02/2021, which provides some information on the conduct of clinical studies during the pandemic from Covid-19.

Publication by the European Commission of the draft document “Clinical Trials Regulation (Eu) No 536/2014 – Draft – Questions & Answers – Version 3”. This document provides some answers to questions related to the entry into force of Regulation (EU) No 536/2014 on clinical trials, scheduled for December 2021.

EMA: Publication of the guides on the use of IRIS, update of the regulations of clinical trials, new guidelines for the registration of drugs.

The document “Questions and answers to Stakeholders on the implementation of the Protocol on Ireland/Northern Ireland” has been updated by EMA. This document provides practical guidance on the rules applicable in Northern Ireland with regard to the activities of the EMA and human medicinal products following the centralised procedure. Many of the questions clarify some of the concerns regarding clinical trials in Northern Ireland.

EMA updated the “Recognition of GMP inspection outcomes under the EU-UK Trade and Cooperation Agreement” section on their website “International collaboration on GMP inspections”. According to the EU-UK Trade and Cooperation Agreement, the EU and the United Kingdom recognise the outcome of the GMP inspections carried out by the other Member in their territories and in other third countries. These rules also apply to Investigational Medicinal Products.

We communicate the publication by EMA of the quick-guides “How to evaluate an Initial Clinical Trial Application: Assessment and Decision CTIS Train – Module 08”.

EMA shall notify the publication of the IRIS User Guides: “IRIS guide for applicants; Quick interactive guide to IRIS registration process; IRIS guide to registration”.

Following is the update by EMA of the “Clinical Trial Regulation” page of their website.

EMA will update the “Clinical Trials Information System (CTIS): training programme” page of their website.

We announce the update by EMA of the guideline ICH guideline M4 (R4) on common technical document (CTD) for the registration of pharmaceuticals for human use – organisation of CTD Step 5”.

AIFA: Updates of the contract for the conduct of clinical trials on medicinal products and publication of new indications on post-marketing surveillance of vaccines COVID-19.

AIFA publishes the note “Studi osservazionali sulla sorveglianza post-marketing dei vaccini COVID-19: indicazioni AIFA” which in reference to the “Circular on simplified procedures for studies and programs of compassionate therapeutic use for emergency from Covid-19” Reiterates the need to submit prospective observational studies on COVID-19 vaccines at the same time as the AIFA and the INMI Lazzaro Spallanzani Single National Ethics Committee.

Notice is given of the publication by AIFA of an update of the contract “Contratto per la conduzione della sperimentazione clinica su medicinali (update)”, to add an amendment to Article 4.2 concerning the availability of the drug by the Promoter.

AIFA has published an update of the contract “Contract for the conduct of clinical trials on medicinal products (update)”, currently under consultation, to include Annexes A and B, Personal data protection budget and glossary respectively.

FDA: Update Guidelines to Support Clinical Trials of Medical Products During COVID-19

Publication by FDA of an update of the guideline “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency” on the conduct of clinical trials of medical products during the public health emergency COVID-19 (version of 27 January 2021)

FONTI:

https://www.aifa.gov.it

https://www.ema.europa.eu/en

https://www.fda.gov/

https://iris.ema.europa.eu/