Europe – Report from the CMDh meeting held on 17-19 September 2019

CMDh and EMA advise companies on steps to take to avoid nitrosamines in human medicines

CMDh and CHMP are requesting as a matter of precaution that marketing authorisation holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. If nitrosamines are detected in any of their medicines, marketing authorisation holders must inform authorities promptly so that appropriate regulatory actions can be taken.

A notice to marketing authorisation holders to this effect is being published on the CMDh website (https://www.hma.eu/226.html) with information on the actions they should take. A questions-andanswers document is also available on the CMDh website. Marketing authorisation holders are responsible for ensuring that every batch of their finished product is of satisfactory quality, including the active substances and other ingredients used to make them. They should take into account the published guidance along with knowledge of the manufacturing processes for their products and all other relevant scientific evidence…