Latest From Ian Schofield
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.
Efforts to overhaul the EU pharmaceutical legislation have been given added impetus after the European Parliament called for action to boost innovation and medicines access, shore up manufacturing and supply chains, and examine the link between R&D spending and drug prices.
The EMA is going all out to maximize coverage of the EU population with both vaccines and treatments for COVID-19.
Drug sponsors seeking centralized EU marketing authorizations now have the opportunity to have simpler pre-submission “interactions” with the European Medicines Agency six months before the submission to help avoid complications down the line. Full meetings may still be appropriate for complex issues such as requests for accelerated assessment or conditional approval.
Coronavirus Notebook: Molnupiravir EU Approval Likely By Year End, Special CHMP Session Due On Comirnaty in 5 to 11-year-olds
The EMA is assessing the Janssen vaccine as a booster, and Switzerland is evaluating the use of the Pfizer/BioNTech and Moderna COVID-19 vaccines in younger age groups. The WHO has announced the first voluntary global license on a COVID-19 antibody detection technology.