GMP News - Blood / Biologics and ATMP

The World Health Organization (WHO) "GMP for Biological Products" draft of the revision is open for comments until September 2015.

The FDA Center for Biologics Evaluation and Research (CBER) published the Guidance for Industy "Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products".

With the new draft the US FDA wants to replace the guidance document "Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products," issued in 1992. Learn more about the draft Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.

The FDA issued the final version of three biosimilar guidance documents related to the BPCI Act from 2009. Read more about the Update of the Biosimilar Guidance Documents.

In 2014, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) published the revision of two annexes of their GMP guide, relevant  for blood and biological products. Read more about the Revision of relevant PIC/S Guidance Documents in 2014.

In January CBER published an overview about the planning of the development and teh revision of guidances in the field of blood, tissues and cellular products. Read more about the Guidance Documents CBER is planning on publishing.

In December 2014, the Food and Drug Administration, Center for Biologics Evaluation and Research published the guidance on "Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture". Read more here.