News

Last weeks round-up; 16 – 20 December 2019

published 23 Dec 2019

MHRA NEWS: NITROSAMINE RISK EVALUATIONS

MHRA has issued a request to MAHs to review their manufacturing processes to identify and, if found, to mitigate risk of presence of nitrosamine impurities. The risk evaluation should be done per the CMDh guidance for MAHs of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines and needs to be completed by March 2020. Further information can be found under this link https://lnkd.in/dXkpA5p

EMA INTERACTIVE TIMELINE

EMA has published a new interactive timeline here https://lnkd.in/dxnrRy3 to demonstrate the journey of a medicine assessed by EMA from laboratory to patient. It includes nice visuals and links to click for further information at each step of the way.

COMPARABILITY PROPOSALS FOR ADVANCED THERAPY MEDICINAL PRODUCTS (ATMP)

CHMP scientific advice questions are often related to the suitability of comparability proposals following changes to ATMP manufacturing details. Manufacturing process changes may encompass improvements/change in equipment, raw materials and critical starting materials such as the cells or the vector or their suppliers, manufacturing process scale or product stability. Oftentimes these changes are frequent, particularly in the early stages of development. Thus, EMA has just issued at Q&A to consider when compiling comparability proposals. Full details can be found under the link https://lnkd.in/dBqFCeD