GMP News - Pharmaceutical Development / Clinical Trials / GCP
GMP News - Pharmaceutical Development / Clinical Trials / GCP
25.01.22
Safety Assessment of Clinical Trials
To ensure effective and efficient safety assessment of clinical trials, the EU Commission published rules and procedures for the cooperation of the Member States. The new Regulation will become applicable on 31 January 2022 - together with the Clinical Trials Regulation (EU) No 536/2014.
The go-live date for the CTIS is 31 January 2022. In order to help sponsors prepare for using the CTIS, the EMA has now published a new version of the sponsor handbook.
Questions and Answers on Labelling Flexibilities for COVID-19 Vaccines
The EMA published an updated version of the Q&A document relating to labelling flexibilities for COVID-19 vaccines. Can a QR code replace the printed expiry date?
FDA publishes Draft Guidance on Visual Inspection of Parenterals
It has been known for some time that the US FDA is working on its own guide on the visual inspection of parenterals. Now the draft has been published as a 15-page document.
COVID-19 Vaccines - Inspections under Emergency Approvals in the US
The GAO report details the number and frequency of FDA inspections of Covid-19 vaccine manufacturers and other biopharmaceutical manufacturers during the pandemic period.
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.
Safety Reporting - Responsibilities for Investigational Drugs and Devices
The FDA published a new draft guidance on the responsibilities regarding safety reporting for investigational drugs and devices. What is required for investigational device exemption studies?
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.