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.
USP Proposal for Contaminant Pyrrolizidine Alkaloids
A new USP chapter <1567> on pyrrolizidine alkaloids (PAs) is being proposed. It discusses some analytical methods and existing challenges to measure PA contaminants in herbal medicinal products.
Approved USP Chapters on Plastic Components used in Manufacturing
The new USP general chapters <665> and <1665> have now finally been approved. Chapter <665> establishes a baseline for the qualification of plastic components used in the manufacturing of pharmaceutical and / or biopharmaceutical drugs.
EU Commission amends Delegated Regulation on Safety Features again
In order to ensure that medicinal products continue to be marketed with a unique identifier (UI) in Northern Ireland, Cyprus, Ireland and Malta, the Commission further extends the temporary derogation from the requirement to decommission UIs of products exported to UK.
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?
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).
HMPC adopts revised Quality Guidelines for Herbal Medicinal Products
EMA´s HMPC adopted the revised Guidelines on Quality and Specifications for herbal substances, herbal preparations and herbal medicinal products. Will a written GACP declaration for the herbal substance now become a requirement?
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?