GMP News - Blood / Biologics and ATMP

09.07.19

FDA keeps an eye on use and marketing of cell and tissue products

The FDA publishes an Untitled Letter to a manufacturer of stem cell products that are used to treat various diseases and are not expected to meet regulatory requirements.

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09.07.19

ATMPs in combination with a medical device - QP task on release

With the coming into force of the Advanced Therapy Medicinal Products (ATMPs) GMP rules as Part IV of the EU GMP Guidelines, a new chapter has been opened on the manufacture and quality control of ATMPs. Special requirements are placed on the QP when an ATMP is combined with a medical device.

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09.07.19

How to handle possibly lifesaving OOS batches of ATMP - A question that concerns manufacturers and authorities

In the context of a Q&A document, the European Medicines Agency (EMA) offers assistance and information on when an Advanced Therapy Medicinal Product (ATMP) can be approved for treatment even in the case of an out-of-specification batch.

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09.07.19

Transmission of multiresistant microorganisms during transplantation

Following incidents involving the transmission of multi-resistant germs during the use of faecel microorganisms for transplantation, the FDA has established additional measures to minimise the risk of transmission.

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25.04.19

FDA issues Warning Letter to Manufacturer of Human Cells, Tissue or Cell based Products

The FDA has published a Warning Letter to a manufacturer of umbilical cord blood products for therapeutic use in humans due to deficiencies in the classification and manufacture of the products.

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25.04.19

FDA publishes Inspection Report for Cells, Tissues and Cell Products

The US FDA published its regular inspection report on Human Cell, Tissue and Cell based Products (HCT/Ps), which also includes current data from 2018.

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03.04.19

ICH M10 - Draft Guideline on Validation of Bioanalytical Methods published for public Comments

On 13 March, the Euroepan Medicines Agency (EMA) published a the draft ICH Guideline M10 on bioanalytical method validation for public comments.

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03.04.19

Updated Information about the Risk of ZIKA Virus Transmission via Cells and Tissues

Based on the updated information from the CDC, the FDA pointed out the current risk assessment for the transmission of Zika virus through blood, cell or tissue products at the end of February.

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03.04.19

Monographs on Vaccines and Immunosera - Revised Expert Guidance

During its 162th session, the European Pharmacopoeia Commission published the revised guideline "Guide for the elaboration and use of monographs on vaccines and immunosera for human use", which helps experts and interested parties in this field to prepare and interpret the monographs.

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06.03.19

Test for bacterials Endotoxin - New EP Chapter on recombinant Factor C open for public Comments

The European Commission and the EDQM have published a new chapter of the European Pharmacopoeia for testing bacterial endotoxins with recombinant factor C (rFC) for public comment.

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20.02.19

EU-FDA MRA to be expanded

The scope of the EU-FDA Mutual Recognition Agreement (MRA) will be extended to veterinary medicinal products, human vaccines and plasma derivatives.

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14.02.19

FDA Guideline on Immunogenicity Testing of Therapeutic Protein Products published

In January, the FDA published a guide on immune responses to protein products: "Immunogenicity testing of therapeutic protein products - Development and validation of assays for the detection of antidrug antibodies".

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06.02.19

Brexit: OMCL Release Decisions still valid?

What happens if a certificate is issued before the withdrawal date but released after this date? New Q&As give a clear answer.

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18.12.18

Gene Therapeutics - FDA updates Requirements for CMC Information

In recent months, the FDA has published a number of documents on gene therapy. With a draft guideline on "Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)", the next step in the update of the relevant guidelines has been taken.

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18.12.18

Transfusion Transfer of Babesiosis - FDA Draft: Recommendations for Risk Minimization

The FDA published a new Draft Guidance on Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis. The recommendations contained in this guidance apply to the collection of blood and blood components, except source plasma.

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