On 22 November, the European Commission adopted the expected new "Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products" as the new stand alone document for the current requirements for authorised ATMP as well as for clinical trials.
The European Directory for the Quality of Medicines and Healthcare Products (EDQM) published a guidance document on the handling and root-cause analysis of Non-Conformity results in quality assessments.
The European Medicines Agency (EMA) proposes a revision of the Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells and published an corresponding concept paper incuding the current scientific developments.
The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) updated the Guidance for Industry "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".
Beginning of February, the European Medicines Agency (EMA) published new information about Advanced Therapy Medicines and how to get to an increased ATMP development and patient access.
After the second public consultation for the EMA Guideline on GMP for Advanced Therapy Medicinal Products there are still uncertainties and a persisting need for discussion of the current regulatory requirements.
End of June, the European Commission issued a stakeholder consultation on the draft guideline Good Manufacturing Practice for Advanced Therapy Medicinal Products.
The European Directorate for the Quality of Medicines & Healthcare (EDQM) published a survey to gather information from relevant stakeholders for elaboration of a chapter on microbiological control of tissues.
Related to the current issues with the ZIKA virus, the FDA published a new guideline about Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products.
