Our Industry Update focuses on the latest impact of COVID-19 on clinical trials, the latest news from the global regulators and much more.
As always, this quarter’s update has been expertly compiled by Christina Hägglund, QA Manager.
COVID-19 Guidance During the Pandemic
- European Medicines Agency (EMA) Implements Temporary Streamline Measures
- Monitoring of Safety, Efficacy and Impact of COVID-19 vaccines in European Union (EU) and European Economic Area (EEA)
- European Commission (EC) Strategy to Support Development and Availability of COVID-19 Therapeutics
- Food and Drug Administration (FDA) Issues Regulatory Guideline on Generics During the Pandemic: Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (fda.gov)
- Guidance on Master Protocols for COVID-19 Trials: COVID -19 Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention (fda.gov)
Latest Regulations and Guidance
Clinical Trial Regulation
On 21 April 2021, EMA’s Management Board confirmed that the Clinical Trial Information System (CTIS) is fully functional and meets all the specifications, as determined by an independent audit. The EC will consider if the conditions set by the Regulation are met and, once confirmed, will publish a notice in the Official Journal of the EU. Six months after this notice, the Regulation will start to apply and the CTIS will go live, the expected date is 31 January 2022.
EMA provides online CTIS training: Clinical Trials Information System (CTIS): training programme | European Medicines Agency (europa.eu) and maintains a Q&A document: Clinical Trials Regulation Questions & Answers Version 2.3 – ECA Academy (gmp-compliance.org)
Guideline for Medicinal Products Containing Genetically Modified Cells
New EU Recommendation on Archiving
Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials: A position paper written by a joint task force from the European CRO Federation and the eClinical Forum.
MHRA Issues Guidelines for Biosimilars
The purpose of this guideline is to provide developers of similar biological medicinal products (also known as biosimilars) with a clear outline of the requirements for biosimilar products in Northern Ireland/Great Britain/UK. Applicants should also take into account principles contained within the Committee for Medicinal Products for Human Use (CHMP) guidelines.
The EC has released updates to ensure stakeholders are prepared for the transition to:
Please read Pegah Kiani’s articles on the MDR regulation for our expert advice on implementation.
The FDA released the results of a recent analysis that illustrates the wide range of Real World Evidence it has used in making regulatory decisions related to medical devices: Leveraging Real World Evidence in Regulatory Submissions of Medical Devices | FDA
FDA – Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry
This guidance provides a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. A harmonized approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the pharmaceutical sector, strengthening quality assurance, and improving supply of medicinal products.
Patient Focused Drug Development
Updates to ICH Guidelines
ICH E6(R3) and E8(R1) Guidelines are being developed. These will include patients’ involvement in the development of clinical trial design and identification of critical to quality factors and associated risk management. ICH has released draft updates – E6(R3): ICH_E6-R3_GCP-Principles_Draft_2021_0419.pdf & E8(R1) E8-R1_EWG_Draft_Guideline.pdf (ich.org)
EMA Publishes Comments on ICH Paper on Patient-Focused Drug Development
MHRA – Proposed Patient and Public Involvement Strategy
New NICE Guidance Supports Shared Decision Making
National Institute for Health and Care Excellence (NICE) defines shared decision making as the collaborative process involving an individual and their healthcare professional working together to reach a joint decision regarding their care. Shared decision making | NICE guidelines | NICE guidance | Our programmes | What we do | About | NICE
Transparency & Data Integrity
ICMRA and WHO Statement on Transparency and Data Integrity
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organisation (WHO) have released a joint statement.
The COVID-19 pandemic has highlighted the importance of making data available to support those involved in developing vaccines and therapeutics, as well as regulators, health authorities and healthcare professionals. Transparency also improves public confidence in vaccines and medicines.
Failure to Submit Results to ClinicalTrials.gov
The FDA has issued its first Notice of Noncompliance to a pharmaceutical company for failing to submit the required summary results information to ClinicalTrials.gov.
FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov | FDA
EMA’s Individual Case Safety Report (ICSR) Implementation Guide
From 30 June 2022, ISO ICSR format as set out in Article 26(2)(a) of the Commission Implementing Regulation (EU) No 520/2012, and the modalities on how to implement and apply the ISO ICSR standard as defined in ICH E2B(R3) shall become mandatory in relation to reporting obligations to EudraVigilance.
The aim of the guide is to help sponsors prepare for the changes and the revised guide includes:
- References to E2B(R3)
- New guidance on the use of the European Directorate for the Quality of Medicines & HealthCare terms for routes of administration and dosage forms
- Updates on the EudraVigilance registration process
- Updates related to the Clinical Trial Regulation (EU) No. 536/2014