In October 2018, the FDA published a new draft guidance with recommendations for a possible requalification of donors who had been deferred because of reactive test results for antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II). Read more about the requalification method under 21 CFR 610.41.
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".
In September, the US Food and Drug Administartion published a draft guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics. It is the revision of the existing guidance from 2010.
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 European Medicines Agency had announced a guideline on GCP for ATMPs. Now, the Draft Guideline on Good Clinical Practice for Advanced Therapy Medicinal Products has been published and is open for targeted stakeholder consultation unti end of October.
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.
As concequence of the adopted new regulations of GMP for ATMPs, the European Commission published a revised version of the Annex 2 "Manufacture of Biological active substances and Medicinal Products for Human Use".
Concerning their activities in the field of ATMP, the EMA Committee for ATMP (CAT) published their work plan for 2018 for the different areas of responsibility from pre-authorisation to used technologies.
Relating to the ongoing experiences in the marketing authorisation of ATMPs, the EMA published an updated version of their "Procedural advice on the evaluation of advanced therapy medicinal product in accordance with Article 8 of Regulation (EC) No 1394/2007".
The European Medicines Agency (EMA) published the first revision on their Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products, considering the experiences since the first adopted version.
