GMP News - Blood / Biologics and ATMP

12.10.17

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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21.09.17

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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21.09.17

Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells

The US FDA published Advisory on Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells Intended for Transfer into a Human Recipient.

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21.09.17

FDA Information about Human Cell and Tissue (HCT/P) related Inspections

The US Food & Drug Administration (FDA) published an overview about HCT/P inspections in the last five fiscal years.

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21.09.17

EMA - New guide for healthcare professionals on biosimilar medicines

The European Medicines Agency (EMA), the European Commission and experts from the Member States issued a new Guide for Healthcare Professionals on Biosimilars.

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16.03.17

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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16.03.17

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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09.02.17

FDA Guidance for Blood Donations with regard to Ebola Virus published

In January the FDA published a guidance for industry on "Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus".

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09.02.17

FDA Draft Guidance on Labeling of Red Blood Cell Units with Historical Antigen Typing Results

On 17 January the US FDA published a draft guidance on "Labeling of Red Blood Cell Units with Historical Antigen Typing Results". It is now open for comments.

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18.01.17

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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16.01.17

3R - European Medicines Agency's Activities in Replacement, Reduction, Refinement of Animal Testing

The EMA published a refelection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs. It is part of the EU strategy that principles of Replacement, Reduction and Refinement must be considered systematically at all times when animals are used for scientific purposes in the EU.

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15.09.16

Revised Recommendation related to Transmission of Zika Virus

Relating to the fast developments in Zika Virus transmisions, the FDA now published a guidance for Industry with Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components.

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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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