Our Industry Update focuses on COVID-19 & the pandemic’s guidance and legislation, the latest news about the EU Clinical Trial Regulation and much more.
As always, this quarter’s update has been expertly compiled by Christina Hägglund, QA Manager.
You can download a pdf of this update here and sign up to receive our updates via email here.
COVID-19 & Pandemic Guidance/Legislation
Lessons Learnt
An article by Dr Peter Marks in Nature Medicine, highlights the need for greater convergence between national regulators in order to learn from Covid-19 and to be better prepared for future pandemics. What regulators must learn from COVID-19 | Nature Medicine
New EU Agreement
An agreement has been reached to ensure the EU is better equipped to manage future health crises, is more effective in managing shortages of medicines and medical devices, and can monitor and report medicines shortages. The agreement will come into force once it has been endorsed by the European Parliament and Council. Deal on stronger role for EU medicines regulator | News | European Parliament (europa.eu)
Revision to the EU General Pharmaceutical Legislation
This legislation sets the main definitions, regulatory incentives and authorisation procedures, as well as the manufacturing, authorisation and post-authorisation requirements for medicines. The aim is to ensure a future-proof and crisis-resistant medicines regulatory system.
There is a public consultation period which runs to 21-Dec-2021.
European Medicines Agency (EMA) Management Board Meeting Highlights
EMA’s continued response to the pandemic, includes details of vaccine reviews, labelling changes for approved vaccines to cover younger age groups, extra doses for people with severely weakened immune systems and boosters for the general population. Highlights of Management Board – October 2021 meeting | European Medicines Agency (europa.eu)
European Commission (EC) Identifies 10 Most Promising Treatments
The list is based on independent scientific advice and focuses on COVID-19 treatment candidates that are likely to be authorised and therefore available in Europe soon, provided their safety and effectiveness are confirmed by the EMA. COVID-19 Therapeutics Strategy (europa.eu)
Remote Source Data Verification and Decentralised Clinical Trials
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated the guidance on remote Sponsor access to Electronic Health Records (EHRs): Access to Electronic Health Records by Sponsor representatives in clinical trials – GOV.UK (www.gov.uk)
The Swiss authorities issue a paper on decentralised clinical trials, where visits do not always have to occur in hospitals but may take place at home: Publications (swissmedic.ch)
Clinical Trial Regulation & UK
EU Clinical Trial Regulation (CTR)
On the 31 January 2022, the CTR 536/2014 will be implemented. The EMA has published the Clinical Trial Information System (CTIS) Go-Live Plan: B.07.a_Public CTIS Go-Live Plan (europa.eu) and there are updates to the Q&A document.
The European Medicines Agency (EMA) has published a CTIS Sponsor Handbook
UK Combined Review – To Be Used From 01-Jan-2022 (but is available now)
The Combined Review provides a single application route and a coordinated review by the MHRA and Research Ethics Committee. Applications must be prepared and submitted using a new part of Integrated Research Application System (IRAS), note European forms, such as Annex 2, will not be available. The combined review should be used for all new CTIMP applications. Combined review – Health Research Authority (hra.nhs.uk)
ICH GCP E6(R3) & E8 (R1)
Good Level of Implementation of and Adherence to ICH GCP
ICH has issued a report sharing the results of its 2021 implementation survey, which evaluated the extent to which its non-founding members and observers apply and follow the ICH guidelines.
Current modernisation and renovation of the ICH Official web site:
- E8(R1) ‘General Consideration for Clinical Studies’ date of coming into effect: 14-Apr-2022
- E6(R3) ‘Good Clinical Practice’ approx. date of coming into effect: ~Nov-2022
MISC Consultations & Guidance
EU
- The EMA has published an FAQ on Electronic Submission of IMP Data to the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD).
- Read guidance on ‘Good Lay Summary Practice’ (GLSP), including how to prepare, write, translate and disseminate summaries of clinical trial results in lay language. GLSP is a mandatory requirement of the CTR.
- Updated guidance on trials of IMP containing genetically modified organisms. The good practice document should be used in conjunction with the common application form specifically developed for this type of IMP, which has also been updated.
- The EMA has published a guidance on generating high quality evidence from registry based studies.
FDA Draft Guidance
- ‘Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices’.
- ‘Benefit-Risk Assessment for New Drug and Biological Products’.
MISC
- MHRA and FDA Joint GCP Symposium. 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. Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK – Clinical Pharmacology Therapeutics – Wiley Online Library
- Updated Guidance on the Reporting of Race and Ethnicity in Medical and Science Journals
Real World Data (RWD) & Real World Evidence (RWE)
RWD studies allow an assessment of treatment effectiveness in diverse non-selected populations and are an important adjunct to Randomised Controlled Trials (RCTs). They offer a useful insight into the quality and outcomes achieved in routine practice, particularly for specific patient groups who are unlikely to meet the eligibility criteria for RCTs.
EMA & Heads of Medicines Agencies (HMA) Draft Report
The EMA and HMA have issued a draft report following their virtual technical workshop held in April 2021 on RW metadata for regulatory purposes.
FDA Draft Guidance
FDA has produced two draft guidance documents relating to using RWD and RWE for submissions.
- Draft guidance addressing the use of data from EHR and medical claims to help support the approval of a new indication for an approved drug, or to support or satisfy post-approval study requirements.
- Draft guidance explaining how Sponsors can comply with the applicable legislations when submitting RWD as part of their submission.
RWD – Therapeutic Agents Receiving Accelerated Approval by FDA
In a JAMA Network Open article, the Author has shown that RWD could not be used to emulate post-approval confirmatory clinical trials. Feasibility of Using Real-world Data to Emulate Postapproval
Oncology Studies Questions Quality of Using RWD
The European Journal of Cancer has issued the findings of a retrospective cohort study on real-world outcomes associated with new cancer medicines approved by the FDA and the EMA.
Medical Devices
The European Databank on Medical Devices (EUDAMED)
This is an IT system developed by the EC to increase transparency and improve surveillance of medical devices (and in vitro diagnostics) that are sold within the EU. There has been a staggered release of EUDAMED and the full launch is expected to be completed by May 2022.