News

Last weeks round-up; 11 – 15 November 2019

published 18 Nov 2019

EMA PRESS RELEASE: REGULATORS ADVICE CAN MAKE A DIFFERENCE

EMA has issued a press release https://lnkd.in/ddzupY5 referring to a recent article in Clinical Pharmacology and Therapeutics https://lnkd.in/ec2Nj5t. The conclusions in the article are that early dialogue and frequent interactions between medicine developers, regulators, HTAs and patients can play a key role in enabling accelerated access of patients to highly innovative therapies that address unmet medical needs. The chair of EMA’s committee for advanced therapies (CAT), Martina Schussler-Lenz, the chair of EMA’s human medicines committee (CHMP), Harald Enzmann, and the head of EMA’s scientific advice office, Spiros Vamvakas describe these interactions through a recent specific example. RRL is experienced in helping companies with the interactions for ATMPs in EU and can navigate companies through the processes.

EMA UPDATED PROCEDURE FOR REVIEW OF ORPHAN DESIGNATION AT THE TIME OF MAA OR VARIATION APPLICATION APPROVAL

EMA has updated its SOP for review of Orphan Designation at the time they are granting approval for an MAA or Variation application. The update is to accommodate the recent change from Eudralink to IRIS and some procedural steps with the associated CRM. The document in its entirety is here https://lnkd.in/djA_G3a