The Medicines and Healthcare products Regulatory Agency (MHRA) has detailed the registration process for submitting applications and reports through national portals. Read more “Detailed guidance on the electronic submission process for applications to the UK”
Category: Trials
Keep up to date with the latest clinical trials news in the pharmaceutical and regulatory affairs industry.
EMA publishes second issue of their Clinical Trials Information System (CTIS) Highlights newsletter
The Clinical Trials Regulation (EU) 536/2014 was implemented to harmonise the process of conducting and monitoring clinical trials across the European Union (EU) whilst simultaneously improving transparency. The December 2020 CTIS highlights newsletter covers the key features and future developments in the CTIS. Read more “EMA publishes second issue of their Clinical Trials Information System (CTIS) Highlights newsletter”
The latest MHRA guidance surrounding clinical trials and Brexit
The Medicines and Healthcare Products Regulatory Agency (MHRA) has released their latest guidance on conducting clinical trials for investigational medicinal products (IMP) after the transition period. It sets out requirements for the registration, publication of summary results and amendments to clinical trials, as well as submitting clinical trial safety reports. Read more “The latest MHRA guidance surrounding clinical trials and Brexit”
MHRA release guidance on submitting clinical trial safety reports from 1 January 2021
How to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs) at the end of the Brexit transition period. Read more “MHRA release guidance on submitting clinical trial safety reports from 1 January 2021”
WHO draft revised guidance on GMP for investigational products
The World Health Organisation (WHO) has released a draft working document to the industry for public consultation on good manufacturing practices (GMP) for investigational medicinal products (IMP). Read more “WHO draft revised guidance on GMP for investigational products”
MHRA guidance on generating real-world evidence in clinical trials
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published draft guidance on randomised controlled trials (RCT) generating real-world evidence (RWE) to support regulatory decisions. Read more “MHRA guidance on generating real-world evidence in clinical trials”
Draft guidance on registry-based studies
The European Medicines Agency (EMA) has addressed the used of registry-based studies in pre-and post-authorisation phases for medicines. Read more “Draft guidance on registry-based studies”
Post-transition guidance from the MHRA: Clinical Trials
On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements for registration of clinical trials for investigational medicinal products (IMP) and submission of substantial amendments. Read more “Post-transition guidance from the MHRA: Clinical Trials”
ICMRA agree on primary endpoints for COVID-19 clinical trials
Global regulators have reached a consensus on acceptable primary endpoints in randomised controlled clinical trials for treatments of COVID-19. Read more “ICMRA agree on primary endpoints for COVID-19 clinical trials”
European Commission proposes relaxation of GMO regulations
The proposal to relax the regulation of genetically modified organisms (GMO) would allow GMO-containing COVID-19 candidate vaccines and therapeutics to proceed with clinical trials. Read more “European Commission proposes relaxation of GMO regulations”