New from the European Medicines Agency – “These Guidelines develop the Gmp Requirements that should be applied in the manufacturing of Atmps that have been granted a marketing authorisation and of ATMPs used in a clinical trial setting.”
These Guidelines are specific to ATMPs. Other documents developing GMP requirements for Medicinal Products which are contained in Volume 4 are not applicable to ATMPs, unless specific reference thereto is made in these Guidelines.
Posted by Dr. Tim Sandle
