Legislation

"While we mourn his passing, we also celebrate his remarkable legacy, which will continue to shape AHPA and the broader industry for years to come,” AHPA says.

Momentum is building around the European Commission’s race to propose a Critical Medicines Act, which aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU.

Annette Dickinson was CRN’s original staff member when she helped form the group in 1973 and retired in 2005 after serving as president since 2003. CRN’s founders saw a need for "an association that was science-based, that took a rational approach to issues, that did not view regulators as necessarily the devil incarnate.”

Responding to the announcement by the US Centers for Medicare & Medicaid Services of the 15 additional drugs that will soon be subject to price negotiation – including Ozempic, Rybelsus and Wegovy – the Association for Accessible Medicines has called out the “short-sighted government price setting scheme” for undermining generic and biosimilar competition.

Recently-appointed president of Medicines for Europe Stephan Eder speaks to Generics Bulletin about the off-patent association’s priorities to secure a sustainable operating environment for the generics, biosimilars and value-added medicines sector in Europe.

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.