Drug trial registration/disclosure rule in China signals more inspections
This article was originally published in SRA
China has introduced registration and disclosure requirements for drug clinical studies that, while their ostensible purpose is to enhance transparency, may also be a prelude to increased clinical trial site inspections by the country's regulator1,2.
You may also be interested in...
The European Medicines Agency says its rolling review tool should speed up the evaluation of AstraZeneca’s COVID-19 vaccine.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, including Blueprint Medicines' Ayvakyt for treating unresectable or metastatic gastrointestinal stromal tumors. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).
Drug companies have their last chance to negotiate which documents and information Italy’s regulator, AIFA, will be entitled to request of them when they submit pricing and reimbursement applications.