Europe’s attempt to unify rules on clinical trials in the 2001 Directive is widely acknowledged to be a disaster. After years of debate, the Commission’s proposals for reform are getting a favourable reception, but it is critical the new regulation takes account of emerging technologies
The UK has brought in new rules it says will make it easier to get permissions to carry out clinical trials of medical devices, such as hip and knee replacements, pacemakers and stents.
The UK is setting up a national network to carry out clinical trials of paediatric medicines, filling the gap left by pharmaceutical companies which usually test drugs only on adults.
The conclusion that there was nothing wrong with the specifics of the TeGenero trial in which six healthy volunteers ended up in intensive care has repercussions for the wider biotech industry.
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