The E6(R3) EWG is currently working on ICH´s Guideline on Good Clinical Practice to address the application of GCP principles to the increasingly diverse trial types and data sources. To update international parties on the EWG’s progress ICH hosted a web conference in May.
Final ICH E8(R1) Guideline on General Considerations for Clinical Trials
The final ICH E8(R1) guideline reached Step 4 of the ICH Process. It provides guidance on the clinical development lifecycle, including designing quality into clinical studies. The next step in the ICH process is to implement the final guidance in ICH member countries.
The Clinical Trials Regulation (CTR) requires in Article 37 that the sponsor of a clinical trial must submit a lay summary. The European Commission has now published a guideline on "Good Lay Summary Practice" (GLSP).
Compassionate Use: EMA supports Submission of Medicinal Product Information
To support voluntary submissions of medicinal product information for medicinal products supplied in the EU / EEA via parallel importation, or for emergency and compassionate use, new 'Legal basis' values will be made available in the "Article 57 database" (xEVMPD).
FDA issues Warning Letter for not complying with Clinical Trial Rules
The FDA issued a warning letter for not complying with regulations during the clinical investigation of a COVID-19- IMP. In particular, the sponsor failed to submit an investigational new drug application.
FDA´s Q&As regarding Clinical Trials during the COVID-19 Pandemic
The FDA updated the Q&As concerning the conduct of clinical trials during the COVID-19 pandemic. The document provides general considerations to assist sponsors in assuring the safety of trial participants & maintaining GCP compliance. Amongst others the guidance deals with electronic signatures, remote monitoring and re-monitoring after pandemic-related restrictions are lifted.
The FDA has published guidance to clarify how considerations about benefit-risk assessment are integrated into the agency´s pre- and postmarket decisions for marketing applications. Read more about FDA´s draft guidance on Benefit-Risk Assessment for New Drug and Biological Products.
FDA´s Q&As on Generic Drug Development during the COVID-19 Pandemic
What can be done when a test or reference product batch used in the conduct of a bioequivalence study expires while the study is interrupted due to the COVID-19 pandemic? Find out in FDA´s updated Q&As on Generic Drug Development.