EMA Human Medicines Highlights for August 2016

The EMA human medicines highlights for August include newly adopted guidelines for GVP on post-authorisation safety studies and product- or population-specific considerations for biologicals.

Also adopted are guidelines on the development, production, characterisation and specification of monoclonal antibodies and related products, and on potency testing of cell based immunotherapy products for the treatment of cancer. A number of guidelines have been released for consultation. For a full list, please click here:
http://www.ema.europa.eu/docs/en_GB/document_library/Newsletter/2016/09/WC500212692.pdf