Clinical Regulatory

The UK Medicines and Healthcare products Regulatory Agency (MHRA) receives approximability 1000 clinical trial authorization (CTA) applications a year. These are for investigational medicinal products of which >95% are approved. However, >50% still need additional information to be submitted in order to get approved. The majority of the requests for additional information, including “grounds for […]

Japan has a robust regulatory framework for pharmaceuticals and medical devices, which includes specific requirements for In-Country Clinical Caretakers (ICCC). Foreign manufacturers that wish to penetrate the Japanese market must appoint an ICC, who resides in Japan, to sponsor the clinical trials on their behalf. Thus, they play a crucial part in ensuring that foreign