Legislation

Changes to the procurement of critical medicines and their active ingredients are among the amendments the Council of the EU has made to the draft Critical Medicines Act.

A Senate hearing on the medical product supply chain suggests there is bipartisan support for ‘buy American’ policies for federal Rx purchases, and for country-of-origin labeling to help those policies expand to the private sector.

The message that the US may lose its lead in biotech to China appears to have bipartisan resonance on Capitol Hill. That sets a favorable context for the kickoff of the next user fee reauthorization process.

Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.

But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.

The next iteration of the user fee program could depart from longstanding agency commitments to issue formal guidance given the Trump Administration’s deregulatory philosophy, policy experts said.

Sanofi’s EU regulatory science and policy head draws on a “nightmare” experience with using a generative AI tool to compare versions of the draft EU pharma reform text to explain the benefits and limitations of artificial intelligence tools in regulatory affairs.

In this second of a two-part series, Clifford Chance partner and life sciences legal expert Gunnar Sachs explains how the upcoming EU Biotech Act could place extra strain on SMEs due to overlap with other regulations and how to mitigate this through careful planning.

While industry awaits specific details on the EU Biotech Act, Clifford Chance partner and life sciences legal expert Gunnar Sachs explains the key aims of the new legislation and discusses the potential benefits for biotech firms.

A French spending bill that would tax drug company turnover would create a “catastrophic competitiveness gap” between France and its European neighbors, warns Leem, the French pharmaceutical industry group.

A Senate Health, Education, Labor and Pensions Committee hearing marked the resumption of lawmakers’ work on 340B reform legislation, which now includes heightened concerns about risk to rural hospitals and community health centers.

Economic woes in France mean that tough and unpopular choices impacting the biopharmaceutical industry are inevitable, according to industry expert Alexandre Regniault.

The exemption from Medicare price negotiation provides relief to drugs with orphan indications that represent significant levels of Medicare spending, the Congressional Budget Office said as it raised its spending forecast.

Navigating national ethics and local compliance requirements is one of the “most difficult” aspects of the EU Clinical Trials Regulation for sponsors. Authorities must focus on improving this area to make the EU an attractive place for clinical trials, says Shionogi’s regulatory policy lead.

Finalized EU pharmaceutical legislation must ensure that patients are fairly represented in regulatory decision making, according to patient and industry experts.

EU trilogs on the new pharmaceutical legislation will finalize the role patients will take in influencing the development of a new definition of unmet medical need.

Revision of the EU’s pharmaceutical legislation will include a new definition of unmet need, but getting it wrong could have unintended consequences for pricing and reimbursement.

While the EU has many pieces of promising legislation in development, regulatory agencies should also prioritize making improvements within the existing framework rather than waiting for the new laws to take effect, EUCOPE secretary Alexander Natz says.

Drawing on around 60 years of experience, the European Directorate for the Quality of Medicines & HealthCare will help the newly formed African Medicines Agency develop robust quality control systems.

France’s social security financing bill for 2026 is due to be presented in parliament in the coming weeks.