China Proposes Stricter Rules And Higher Penalties For Recalls
Executive Summary
The China Food and Drug Administration wants to expand the scope of products subject to recall and increase the penalties for wrongdoers.
You may also be interested in...
China To Get Tougher On Recalls Beginning In May
More stringent recall rules in China will see the maximum penalty for failure to carry out a mandatory recall rise from three times the value of a medical device, to up to ten times its value.
China Clinical Data Crackdown Sees Device-Makers Withdraw 101 Applications
China FDA is now relentlessly clamping down on clinical data irregularities in the medtech industry, causing 51 manufacturers, including well-known multinational companies such as Boston Scientific and Olympus, to withdraw more than a hundred new device approvals filed with the agency.
EMA Probe Finds No Link Between GLP-1s And Suicidal Thoughts & Actions
After reviewing the evidence from non-clinical studies, clinical trials, post-marketing surveillance data and other studies, the European Medicines Agency said there was no need to update the product information for 11 diabetes and weight management drugs.