News Archive

EMA - CTIS Handbook on the website

10th August 2021

The EMA Clinical Trial Information System (CTIS) Sponsor Handbook is now available on the EMA website.

Read More+

EMA - Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

4th August 2021

Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders - now available.

Read More+

BMJ - The review of the global first SARS COV 2 Human Infection Challenge studies

3rd August 2021

Expert and lay members of UK RECs recognised to review Clinical Trials of Investigational Medicinal Products (CTIMPs) or Phase 1 studies in healthy volunteers, particularly those with experience of vaccine studies, were invited to join an ad hoc Research Ethics Committee to review SARS COV 2 Human Infection Challenge studies (HICS). All were asked to attend two virtual HRA workshops before the first committee meeting (and all did!) and were provided with articles from both sides of the argument for further reading. Given the pandemic lockdown, we met virtually, ensuring broad representation across the UK nations, and that applicants were easily able to attend (of huge help to our review).

Read More+

EMA - Draft IMP documents for comment

3rd August 2021

'Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials' and 'Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials'.

Read More+

EMA - Six-month countdown to go-live for the Clinical Trials Information System (CTIS)

3rd August 2021

The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and hence the go-live date for the Clinical Trials Information System (CTIS) will be on 31 January 2022.

Read More+