How to show MHRA you’re meeting good clinical practice (GCP) standards and what to expect from an inspection. Read the update from Medicines and Healthcare products Regulatory Agency published on 6 April 2023.
The “Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice” came into effect on the...
Quick guide on the main rules and procedures of the Clinical Trials Regulation (EU) No 536/2014 (CTR) for sponsors who wish to conduct clinical trials (national and multinational) in the European Union (EU) / European...
The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug (IND) application. The guidance now includes new frequently asked questions about how expanded...
The intention of the recommendation paper is to facilitate the use of decentralised elements in clinical trials in the EU/EEA. However, the necessary level of trial participant’s safety, protection of their rights and dignity should...
The MHRA has now retired the eSUSAR website in favour of Individual Case Safety Reports (ICSR) Submissions, providing users “a more robust, stringent, and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs)...
Following a 1-month feedback period on the draft published in June this year the European Commission (EC) adopted on 6 September the revised Annex VI to Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR) as...
The Medicines and Healthcare products Regulatory Agency is playing a pivotal role helping to ensure that the UK remains one of the best places in the world to deliver safe, cutting-edge research. Read more News...
