GMP News - Blood / Biologics and ATMP

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".

more

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.

more

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.

more

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.

more

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”.

more

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Currently, the CBER issued a draft guidance document on the bacterial testing of platelets intended for transfusion.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".

more

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).

more

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.

more

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.

more

17.03.16

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.

more

17.03.16

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".

more

25.02.16

Zika Virus and Blood Donations - Current Recommendations of the FDA

FDA reacts to the Zika Virus hype with a new guidance document: " Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus" by blood and blood components.

more

25.02.16

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".

more

25.02.16

Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products

As the latest in a series of guidances addressing the risk of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD)1 transmission by blood and blood products, the FDA published the "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products".

more

04.02.16

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)".

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics