GMP News - Blood / Biologics and ATMP

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

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

The FDA published a new Draft Guidance on Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis.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.

Due to the ongoing scientific development of laboratory methods, the EMA published a draft revision of their "Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells" for public consultation.

FDA published their recommendations for further testing if the result of a donor screening test for antibodies to the hepatitis C virus (anti-HCV) came out positive. These recommendations may be found in the draft guildeline on "Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus".

Relating to the increasing need of simultaneously evaluatation of more than one investigational drug and/or more than one cancer type in one clinical trial, the FDA published a new guidance on Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.

The increasing importance of Gene Therapy becomes obvious when you take a look at the increasing focus of the competent authorities - as, for example, the current FDA's six new guidance documents on Gene Therapies show.