Legislation

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.

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.

France’s medtech sector is strong, growing and innovative. In Vivo spoke to several French medtech leaders about the unique features and pitfalls their industry may face.

FDA Office of Nonprescription Drugs explains in its proposed commitment letter for fiscal years 2026-2030, based in part on suggestions by stakeholders, that it will heighten its attention to collecting those fees.

New regulations on clinical trials should help the UK remain a popular destination for multinational trials, according to the MHRA, the country’s medicines regulator.

Texas bill filed in advance of the state’s next legislative session starting in January while bills proposing prohibiting sales of supplements and OTC drugs for weight loss or bodybuilding to minors remain active in three states where current sessions continue, Massachusetts, Michigan and New Jersey.

The collapse of the French government brings more uncertainty for the pharmaceutical industry.

Europe risks “missing out on a massive opportunity” if it does not improve its efforts to recognize and take advantage of the benefits of value added medicines, according to Medicines for Europe sector chair and Pharmanovia CEO James Burt.

The pharma industry arguably suffered none of the possible downside risks during the first Trump Administration, but its relationship with Biden could not have been much worse. And while sponsors may hope a Trump return could improve their fortunes, having Robert F. Kennedy Jr. supervising the FDA is likely not the prescription they prefer.

The pharma industry arguably suffered none of the downside risks that were possible during the first Trump administration, and their relationship with Biden could not have gone much worse. And while they may hope a Trump return could help their fortunes, having RFK Jr. supervising the FDA is likely not the prescription they want.