Tuesday, 30 January 2018

GMP guidelines specific to Advanced Therapy Medicinal Products (ATMPs)


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.

See: EMA

Posted by Dr. Tim Sandle

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