Regulatory Guidance Q1 2022

Our Industry Update returns for this first update of 2022 and focuses on COVID-19, forthcoming regulations, EMA initiatives, 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

Report on the Review of Regulatory Flexibilities/Agilities as Implemented by National Regulatory Authorities During the Pandemic

The International Coalition of Medicines Regulatory Authorities (CMRA) and World Health Organisation (WHO) outline regulatory flexibilities during the Covid-19 pandemic.

EMA Documents Applicable to Clinical Trials Authorised Under Clinical Trial Regulation (EU No 536/2014)

Guidance on the management of clinical trials during the Covid-19 pandemic. EudraLex – Volume 10 (

UK – Lessons Learnt

Regulator’s experience of clinical trials during the Covid-19 pandemic. MHRA Inspectorate ( Part 1 and MHRA Inspectorate ( Part 2

New and Upcoming Regulations

EU Clinical Trial Regulation (CTR) 536/2014

  • Up to end of January 2023, Clinical Trial Applications may be submitted in EudraCT (and be governed by the EU Director) OR via the new EU Portal – the Clinical Trials Information System ‘CTIS’ (and the clinical trial will be governed by the CTR).
  • For the following 24 months (beginning of February 2023 to end of January 2025) all initial CTAs must be submitted via CTIS (and be governed by the CTR).
  • From 3 years after the go-live date (February 2025 onwards) all new CTAs will be governed by the CTR regardless of their date of submission.

The CTR Q&A document (EudraLex Volume 10) has been updated: Clinical Trails Regulation (EU) NO 536/2014 Questions & Answers and a CTIS Sponsor Handbook is available

CTIS and Data Protection

The European Medicine Agency (EMA) has released the Joint Controllership Arrangement for the processing of personal data in CTIS in accordance with the General Data Protection Regulation (GDPR) and the EU Data Protection Regulation.

GDPR Code of Conduct

The GDPR Code of Conduct on Clinical Trials and Pharmacovigilance (by the European Federation of Pharmaceutical Industries and Associations (EFPIA)) has reached the final review stage prior to being formally submitted to the European Data Protection Board for approval.

EU Safety Regulation

The EU has published the Commission Implementing Regulation 2022/20 which documents the rules and procedures for the cooperation of EU Member States in the safety assessment of clinical trials in accordance with the new CTR. The Regulation became applicable at the end of January 2022.

New Mandate Strengthens Role of EMA

Regulation (EU) 2022/123 reinforces the role of the EMA in crisis preparedness and management for medicinal products and medical devices. This is done by entrusting processes established by the EMA during the pandemic, as well as some new tasks, to the EMA. The Regulation became applicable on 01 February 2022.

UK Proposal for Legislation Changes for Clinical Trials

The proposal aims to ensure the UK retains and grows its reputation as a world leading base for life sciences. This is done by reframing the UK legislation for clinical trials to a more streamlined and flexible regulatory regime whilst protecting patients and trial participants.

EMA Initiatives

Regulatory Science Research Needs

The EMA has issued a list of regulatory science topics where further research is needed to improve medicines development and evaluation. This is necessary in order to enable access to innovative medicines for patients.

Accelerate Clinical Trials in the EU (ACT EU)

This is a joint project by the EMA, European Commission (EC) and the Heads of Medicines Agencies. The implementation will support the operation of the CTR. Regulatory harmonisation of clinical trials in the EU

Real World Data (RWD) & Real World Evidence (RWE)

MHRA Guidance Documents on the Use of RWD to Support Regulatory Decisions

Points to consider are included in two MHRA documents.

Food and Drug Administration (FDA) Draft Guidance

Considerations for the Use of Real-World Data and RealWorld Evidence to Support Regulatory Decision-Making for Drug and Biological Products. Comments are to be submitted by 08 March 2022.

FDA Draft Guidance

Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry. The guidance addresses a legislative requirement to issue guidance about the use of RWE in regulatory decision making.

Medical Devices

European Database for Medical Devices

The European database on medical devices (EUDAMED) is an IT system developed by the EC to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. You can read a general overview here.

FDA Guidance Documents

The FDA has issued two final guidance documents on the evaluation of medical devices: Principles for Selecting, Developing, Modifying, and Adapting and Patient Engagement

MISC Guidance Documents


European Union



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