Pharma GMP News of the Week: 05-September-2021
Period: August 29, 2021 to September 04, 2021
FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards
Date of release: August 30, 2021
FDA recognizes that the COVID-19 public health emergency may impact the conduct of clinical trials of medical products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial participants become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing.
FDA recognizes that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 public health control measures.
FDA outlines the following general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity.
A. Considerations for ongoing trials:
B. In general, and if policies and procedures are not already in place for applicable trials:
C. For all trials that are impacted by the COVID-19 public health emergency:
The appendix further explains those general considerations by providing about 28 answers to questions about conducting clinical trials that the Agency has received during the COVID-19 public health emergency.
The European Commission seeks stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities
The Commission Implementing Regulation (IR) on the performance of pharmacovigilance activities was adopted in 2012. It outlines the practical details to be respected by marketing authorisation holders, national competent authorities and the European Medicines Agency (EMA).
As part of the Pharmaceutical Strategy for Europe, the Commission is not only committed to evaluate and review the general pharmaceutical legislation, but also to update and optimise existing implementing measures like the IR. The overall experience with the IR is good. However, following consultation with the EMA and the Pharmacovigilance Risk Assessment Committee, the need for some targeted amendments has been identified to take account of the experience gained and to update certain provisions in view of new technical standards being applied. The aim of this consultation is to inform and consult on those amendments. They focus on the following sections of the IR:
Chapter I – Pharmacovigilance system master file,
Chapter III – Minimum requirements for the monitoring of data in the Eudravigilance database,
Chapter IV – Use of terminology, formats and standards,
Chapter V – Transmission of suspected adverse reactions,
Chapter VIII – Post-authorisation safety studies.
While this consultation primarily seeks the stakeholders’ feedback on those proposed amendments, the Commission welcomes any additional remarks that could improve the application of the IR.
Revised guidance for electronic submissions for CEP applications
As the eCTD format is mandatory for the submission of all applications for Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs), except for applications for the risk of transmissible spongiform encephalopathy (TSE) (PDF format) and for substances for veterinary use (eCTD or VNeeS format), the European Directorate for the Quality of Medicines & HealthCare (EDQM) document “Guidance for electronic submissions for Certificates of Suitability (CEP) applications” (PA/PHCEP (09) 108) has been updated to reflect the current practices to facilitate submissions for applicants.
An important update is that when switching to the eCTD format from another format, it will be mandatory to include any information already assessed and approved previously in a “baseline (full dossier)” to facilitate the lifecycle management of the dossier. This will be implemented at the latest in January 2022. Applicants are invited to do so as soon as possible, however. In addition, based on applicants’ feedback, a number of clarifications are given for specific topics such as the submission of grouped revisions and examples of format issues hindering the receipt of applications.
Blog post on MHRA site about “MHRA and US FDA tackle challenging data integrity”
The second Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) joint Good Clinical Practice (GCP) symposium was held in London in February 2020, covering international collaboration, sponsor oversight, electronic source documents, protocol deviations and data quality in novel clinical trial designs.
Paper is published around emerging trends and compliance issues as the COVID-19 pandemic evolved, and the paper evolved with it. The paper discusses both agencies’ considerations on data integrity topics, from decentralised clinical trials, adaptive design trials and management of protocol deviations to real-world data. It was great working on this with our FDA colleagues and keeping up with them throughout the pandemic. The paper was published with the hope to provides a useful insight to readers.