Regulation

The long-awaited post market surveillance regulation for medical devices on the Great Britain market will come into force on 16 June.

The UK market has become tougher for smaller innovators, says Andy Mears, CEO of Deltex Medical, which plans to launch a new iteration of its minimally invasive ultrasound-based technology, the oesophageal Doppler monitor. He explained how market access challenges have steepened.

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.

As efforts to improve diversity in clinical trials gain momentum globally, regulators in the UK, the EU, Canada, Australia and Japan were asked about their efforts to support representative enrolment. 

EU joint clinicals assessments introduced under the HTA Regulation have now gone live for cancer medicines and advanced therapies.

Testing by third-party lab accumulated 35,862 data points from 70 brands and 160 products as a benchmark for the study’s findings. Council for Responsible Nutrition criticized the study as lacking “critical context” and potentially “misleading consumers rather than empowering them.”

Pharmaceutical industry says the transition from paper to electronic product information, as part of EU pharmaceutical reforms, should not be held back by member states' readiness.

Egypt is the first African country to win a WHO maturity level 3 benchmarking rating for medicines and vaccines that are locally produced and imported.

AHPA’s significant legislative victories included enactment of Dietary Supplement and Nonprescription Drug Consumer Protection Act in 2006 to establish a serious adverse event reporting law for vitamin, mineral and supplement products.