The Indian health ministry has announced that certain drugs approved for use in...
Indian health ministry fast-tracks drug approvals with new clinical trial legislation
The Indian health ministry has announced that certain drugs approved for use in territories such as the EU and US will be automatically approved in India without a further native clinical trial taking place, in a bid to give patients faster access to new medicines.
UK’s MHRA to release guidance on registration of clinical trials
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is set to release guidance on registration of clinical trials, in case UK leaves the EU without a deal in place.
FDA clears VLP Therapeutics’ application for malaria vaccine trial
The US Food and Drug Administration (FDA) has granted clearance for VLP Therapeutics’ investigational new drug (IND) application to conduct a Phase I/IIa clinical trial of its malaria vaccine, VLPM01.
EMA publishes revised guidelines on antibacterial drug development
The European Medicines Agency (EMA) has published revised guidelines on the development and evaluation of human medicines intended to treat bacterial infections.