Ian Schofield
Executive Editor

Latest From Ian Schofield
Austria & Germany Call For ‘Competitiveness Check’ On EU Pharma Revision Package
The two countries want the European Commission’s proposals to be more closely examined for their possible negative effect on pharmaceutical investment decisions. The industry federation EFPIA says it is surprised more EU member states aren’t taking the same stance.
EU Bodies Agree On Ways To Future-Proof EMA Funding System
EU ministers say that implementing an appropriate fee structure that is more in line with actual costs will promote innovation in the pharmaceutical sector while ensuring “fair access” to safe and effective medicines for patients.
Coronavirus Notebook: UN Pandemic Declaration Disappoints, Focus Turns To Draft WHO Treaty
The World Health Organization has published a “step-by-step guide” for countries wishing to increase their capacity for monitoring pathogens with pandemic and epidemic potential. The EU and the UK have cleared an updated version of Moderna’s COVID-19 vaccine Spikevax targeting the XBB.1.5 variant, while the EU has followed the US in approving Gilead’s Veklury as the first treatment for COVID-19 patients with mild-to-severe liver damage.
EU Could Soon Have Three XBB.1.5 COVID-19 Vaccines For Winter Season
The head of the European Medicines Agency says a group of international regulators got together to ensure “global alignment” on the approach to be taken on COVID-19 vaccination.
Dissent In Parliament As Commission Claims EU Pharma Revision Will Improve Competitiveness and Access
Proposals on regulatory data protection and transferable exclusivity vouchers to encourage antimicrobial R&D have received mixed reactions from the parliament’s rapporteurs for the draft legislation.
New Swiss Database To Cut Costs Of GMP/GDP Certification
A new database being set up in Switzerland is expected to improve the exchange of GMP and GDP information between the regulatory authorities and pharmaceutical companies and offer free access to electronic certificates.