The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have implemented two changes to the UK amendment process for clinical trials from 25 March 2021. Read more “Key changes to UK amendment process for clinical trials”
Category: Trials
Keep up to date with the latest clinical trials news in the pharmaceutical and regulatory affairs industry.
Detailed guidance on the Target Development Profile Toolkit
When the Innovative Licensing and Access Pathway (ILAP) was launched at the start of 2021, it was announced that the Target Development Profile (TDP) will be available to applicants to support their application through this pathway. Read more “Detailed guidance on the Target Development Profile Toolkit”
HPRA announces Clinical Trials Regulation-National Collaboration Project
Ireland’s Health Products Regulatory Authority (HPRA) has launched the Clinical Trials Regulation-National Collaboration Project (CTR-NCP). Read more “HPRA announces Clinical Trials Regulation-National Collaboration Project”
The future of UK clinical research delivery
The United Kingdom (UK) government has released a policy paper detailing its vision for the future of clinical research in the UK. Read more “The future of UK clinical research delivery”
MHRA pilots patient involvement in new medicines applications
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the launch of a pilot project aimed at ensuring patient involvement in clinical trials and medicines development. Read more “MHRA pilots patient involvement in new medicines applications”
Conducting clinical trials of a medical device in Switzerland
Following an earlier announcement from the Swiss Federal Council on the revision of the Ordinance on clinical trials with medica devices (ClinO-MD), Swissmedic has recently released practical advice for applicants on the transition to the new regulation. Read more “Conducting clinical trials of a medical device in Switzerland”
EMA Management Board March 2021 meeting highlights
The latest meeting of the Management Board of the European Medicines Agency (EMA) highlights the latest developments in the key regulatory activities of the agency. Read more “EMA Management Board March 2021 meeting highlights”
MHRA details pathway for clinical investigations of medical devices
Updated guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) on clinical investigations of medical devices covers the specifics of the coordinated assessment pathway pilot along with new information on gaining approval.
Read more “MHRA details pathway for clinical investigations of medical devices”
EC proposes “HERA Incubator” initiative to pre-empt the threat of COVID-19 variants
The European Commission (EC) has proposed an action plan called the “HERA Incubator” to shape the European Union’s (EU’s) strategy for combating the threat of future COVID-19 variants. The initiative is modelled on the annual influenza vaccine programme. Read more “EC proposes “HERA Incubator” initiative to pre-empt the threat of COVID-19 variants”
MHRA provides guidance on managing COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials
The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their guidance document on managing clinical trials during COVID-19 with a new section pertaining to the management of non-COVID-19 trials in the context of the current COVID-19 vaccination programme. Read more “MHRA provides guidance on managing COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials”