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European Notebook: EMA Conflict Of Interest Rules; EU Unitary Patent; EMA Adverse Event Literature Screening

 
• By John Davis

EMA tightens rules on the revolving door between industry and scientific (if not regulators); the European unitary patent proposal survives Spain's judicial challenge; Switzerland amends its drug pricing procedures, and more in this month's column.

The European Medicines Agency is tightening its procedures to stop its scientific experts continuing to participate in any of its activities if they intend to become an employee of a pharmaceutical company, in a rule announced May 6.

The new guidance extends the current ban on such experts being on European Union scientific committees such as the Committee...

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More from Europe

Merck, AstraZeneca Downplay Impact of European Tariffs Despite Timing Uncertainties

 
• By Cathy Kelly

Meanwhile, companies continue discussions with the Trump Administration over ways of increasing what European nations pay for drugs as an alternative to imposing a Most Favored Nation drug pricing policy in the US.

EU 2025 Novel Drug Approvals See Conditional Authorizations Outpacing Previous Years

 
• By Neena Brizmohun

The six EU conditional marketing authorizations granted in the first half of 2025 alone equal the full count for 2024 and come close to the annual totals for the previous two years. Meanwhile, H1 2025 saw a 30% rise in new active substance approvals compared to the same period last year.

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By Vibha Sharma

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

EU 15% Tariff Deal Still Leaves Questions For Pharma On Possible Grace Period, Generic Exemption

 
• By Jessica Merrill

While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.

More from Geography

Expedited Reviews For China-Originated Drugs Shift Back Home

 
• By Xu Hu

The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.

EU 15% Tariff Deal Still Leaves Questions For Pharma On Possible Grace Period, Generic Exemption

 
• By Jessica Merrill

While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.

Medicare Part B ASP Proposal Sets ‘Guardrails’ Around Bona Fide Service Fee Reporting

 
• By Cathy Kelly

Average sales prices, and Medicare spending on some drugs, would be expected to be lower, CMS says in the Physician Fee Schedule proposed rule.