Italy claims to have pushed farther into managed entry agreements than other European countries with strong clawback provisions on new drugs – particularly cancer drugs – if they don't work as well as their manufacturers claim. The financial clawbacks are supported by extensive outcome data collection across the country's twenty regions.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
