Swiss Agency Firms Up Role In Multi-Country Drug Review Scheme
New Guidance Explains Workings Of Project Orbis
Experience gained from pilot participation has convinced the Swiss medicines agency that the collaborative cancer drug review initiative is the way forward.
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Promising cancer medicines will need to be included in the UK’s new licensing pathway for innovative drugs before the UK medicines regulator will agree to their review under the Project Orbis initiative.
Target product profiles, database locks, infarct size as a surrogate endpoint, and changes in the manufacturing process featured in a session of this year’s TOPRA Symposium on dealing with tricky regulatory questions.
Amid growing concern over the new Omicron variant of the coronavirus, member states of the WHO are gathering this week to discuss the negotiation of a convention on future pandemic preparedness and response, with access to medical countermeasures on the agenda. A parallel WTO ministerial meeting that would have discussed the proposed TRIPS IP waiver has been postponed until further notice.