Reducing dependence on Type II variation fees would free lifecycle management guideline from European Commission’s legal concerns.
The European Commission is considering revisions to the European Medicines Agency’s fee system that are expected to clear the way for final approval of the International Council for Harmonisation’s Q12 guideline on lifecycle management when the ICH meets 16-20 November in Singapore.
The expected revisions would likely enable the EC to remove its legal objections to portions of the
The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.
Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.
England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.
