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EMA publishes Concept Paper on Revision of the Guideline on Clinical Development of Vaccines

The EMA published a Concept Paper on the revision of the 10 years old guideline on clinical evaluation of vaccines, relating to the ongoing advancements in the field of vaccine development.

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EMA publishes first Guidance for Stem Cell Therapies in Animals

In June, the EMA published a new Q&A document on the sterility of allogenic stem cell therapies in the veterinary sector. It represents the first guidance document on this topic.

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GMP for ATMP - European Commission adopts new Guideline

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.

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EDQM publishes Guidance for root-cause Analysis of non-satisfactory external Quality Assessment Results

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. 

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Guideline for Medicinal Products containing genetically modified Cells - EMA plans Revision

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.

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Guidance for Industry: Transmission Risk of West Nile Virus from Living Donors of Cells and Tissues

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)".

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PIC/S statement to European Commission's ATMP GMP Guideline

The PIC/S published a harsh letter to the European Commission relating to their draft guideline on GMP for Advanced Therapy Medicinal Products (ATMP).

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Ongoing developments in the field of ATMP

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.

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GMP for ATMP - two Public Rounds of consultation and still a Need for Discussion?

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.

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European Commission: Draft Guideline GMP for ATMP open for stakeholder consultation

End of June, the European Commission issued a stakeholder consultation on the draft guideline Good Manufacturing Practice for Advanced Therapy Medicinal Products.

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