News

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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EDQM Survey on new General Chapter on microbiological Control of Tissue

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.

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ZIKA Virus - Reducing the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products

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.

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ATMP - Monthly Report of the CAT January 2016

The CAT monthly report of the January meeting 2016 provides you with information about statistical data, classification of ATMP, scientific advice and more on ATMP. Read more about application procedures, guidelines and related documents on advanced therapies.

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FDA Draft Guidance on NAT tests to reduce the risks of HBV transmission from cells and tissues

Microbiological Safety of Human Cells, Tissues, and Cellular and Tissue-Based Products: FDA published a draft guidance on the "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus".

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FDA publishes Draft Guidance for Industry "Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products"

FDA's CBER published a Draft Guidance for Industry with recommendations and examples for "Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271".

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Guidance for Treponema pallidum Screening of donors of Human Cells and Tissues (HCT/Ps)

End of 2015, the FDA finalized their draft document and issued the Guidance for Industry "Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis)".

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FDA issues draft guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products

The US FDA published a draft guidance for Industry on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products which is supposed to provide recommendations for applying Title 21 of the Code of Federal Regulations.

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European Pharmacopoeia - Chapter 2.6.27 Microbiological Examination of cell-based Preparations revised

The issue 27.3 of Pharmeuropa also comprises a revision of Chapter 2.6.27 "Microbial Examination of cell-based Preparations". It covers the cases where a test is not feasible according to chapter 2.6.1.

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