Posted by Michael Wonder on 13 Nov 2019
Regulators’ advice can make a difference for faster patient access to highly innovative therapies
12 November 2019 - Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies and patients can play a key role in delivering robust data needed to enable accelerated access of patients to highly innovative therapies that address unmet medical needs.
The chair of EMA’s committee for advanced therapies, Martina Schussler-Lenz, the chair of EMA’s human medicines committee, Harald Enzmann, and the head of EMA’s scientific advice office, Spiros Vamvakas describe these interactions through the example of the recent authorisation of Zynteglo (lentiglobin) in a perspective piece published in Clinical Pharmacology & Therapeutics.
