GMP News - Blood / Biologics and ATMP

15.09.16

FDA Guidance on Determining Donor Eligibility for Autologous Donors of Blood and Blood Components

In addition to the existing guidance on donor eligibility, the FDA published a new guidance document on " Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use"

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15.09.16

Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products

The US Foood & Drug Administration (FDA) published an Draft Guideline on the Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products.

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01.09.16

EMA - requirements for quality documentation concerning biological investigational medicinal products

The European Medicines Agency published a new draft on the Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials.

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01.09.16

FDA Scientists - West Nile Virus and Blood Donor Screening

FDA scientists gained insights in the genetic changes in West Nile Virus that could affect its spread and the ability of blood donor screening tests, future treatments, and vaccines to work effectively.

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01.09.16

EMA - Activities to reduce the Use of Animal Testing

End of July, the Europeam Medicines Agency published a draft "Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs". It is a part of the strategy to reduce animal testing in laboratories.

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02.08.16

FDA - Blood Collection and Zika Virus in Florida

Related to some non-travel related cases of Zika virus, the FDA published a new "Advice to Blood Collection Establishments on Non-Travel Related Cases of Zika Virus in Florida".

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02.08.16

WHO Technical Report - GMP for Biological Products adopted

As a part  of their Technical Report Series with guidance documents comprising recommendations for biological products, the The World Health Organization (WHO) now published "Annex 2 - WHO good manufacturing practices for biological products".

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02.08.16

FDA Guidance for Blood Donor History Questionnaires and Accompanying Materials

The US FDA implemented the updated Guidance for Industry Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components.

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02.08.16

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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02.08.16

EMA publishes Reflection Paper on Viral Safety of plasma-derived Medicinal Products with Respect to Hepatitis E Virus

The EMA published the final "Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus" after the completion of the accepted comments of the public consultation.

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12.04.16

Q&A - Reducing the Risk of Transfusion-Transmission of Zika Virus

In addition to their Guidance on donor screening and deferral concerning the risk of ZIKA virus transmission, the FDA now published a Q&A documenmt to answer the common questions of blood establishments. Read more about the "Questions and Answers Regarding “Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry”.

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12.04.16

Platelets for Transfusion - Bacterial Detection Testing by Blood Establishments

Currently, the CBER issued a draft guidance document on the bacterial testing of platelets intended for transfusion. The document is open for comments and should, when finalized, supersede the recommendation in regard to bacterial contamination testing in the document entitled “Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods”. Find out more in the draft "Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion".

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12.04.16

Monoclonal antibodies as similar biotherapeutic products - Draft Guideline

Biosimilarity of Monoclonal Antibodies - the WHO published a revised draft of their Guidelines on evaluation of monoclonal antibodies as 5 similar biotherapeutic products (SBPs).

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17.03.16

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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17.03.16

EMA Guideline on the clinical evaluation of Factor VIII products published

The EMA published the new Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products with necessary information when an application for a marketing authorisation for recombinant or human plasma-derived factor VIII products is made.

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