Regulatory Guidance Q4 2021

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 (

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 (

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 (

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 (
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 (

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 ( 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 (

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


FDA Draft Guidance


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.

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.

If you require support or advice with any issues raised by this latest industry and Clinical Trials update, please contact us here.