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.
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.
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.
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"
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.
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.