The UK government has announced much-awaited reforms to its clinical trials framework, explaining how several existing provisions will be soon replaced with new legislation or guidance. The changes, the government says, will make it faster and easier to gain approval and to run clinical trials in the country.
UK’s Revamped Clinical Trials Framework To Offer Faster Application Review Timelines Than EU
Changes Represent Biggest Overhaul In UK Clinical Trials Regulation In Over 20 Years
The UK has finalized plans for delivering what it believes will be a stable and streamlined clinical trials framework following its departure from the EU. Transparency, patient involvement and diversity are high on the agenda.
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The European Medicines Agency has published new policies on handling conflicts of interests for its scientific committee members, experts and management board members.
The MHRA’s new scientific dialog program will offer drug developers “closed-door meetings” that will offer “confidential, commercially sensitive discussion” with its staff to help them “refine” their real-world evidence generation strategies.
The European Commission's 100-day countdown to deliver a Critical Medicines Act, aimed at improving the EU's resilience to supply chain disruptions and price volatility, began last December. Meanwhile, negotiations over the proposed package that will reform the over 20-year-old EU pharmaceutical legislation are now in the hands of the Council of the EU. The Pink Sheet examines what to expect for these key pieces of legislation this year.