Regulatory News January 2022

Keep up to date with regulatory news from around the world with the Cell and Gene Therapy Catapult regulatory newsletter.


Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA Proposal for the Future of UK Clinical Trial Legislation

The MHRA have launched a public consultation on a set of proposals to improve and strengthen the UK clinical trials legislation to make the UK the leading global centre for innovation research design and delivery across all types of clinical trials.

The eight -week consultation aims to develop a system that promotes patient and< public involvement in clinical trials, improve diversity of participants, streamline approvals and enable innovation and enhanced transparency of clinical trials.

The consultation will run from 17th January until 14th March 2022.

To read the full press release, see here. The public consultation is available here.


European Commission (EC)

EC Publish Process for Allocation of Safety Assessing Member State

The EC have released an implementing regulation detailing the process for allocation of a member state responsible for assessing safety information in clinical trials involving multiple member states.

The reporting member state will be required to assign a safety assessing member state for each active substance in a clinical trial. The implementing regulation sets out the process for selection of a safety assessing member state and details their roles and tasks, including screening and assessment of suspec ted unexpected serious adverse reactions, assessment of annual safety reports, recommendations of corrective measures for safety oversight related to the active substance and coordinated safety assessment.

To read the Implementing Regulation, see here.

EU Launch Clinical Trials Transformation Initiative

The EC, Heads of Medicines Agencies (HMA) and EMA have launched a new initiative intending to transform how clinical trials are initiated and run to help promote clinical research in the EU. The paper entitled “Accelerating Clinical Trials in the EU (ACT EU)” sets out the goals of the initiative and priority areas for 2022 – 2023, including:

  • Map exis ting initiatives and develop a governance rationalisation strategy (aligning different expert groups and working parties).
  • The successful and timely implementation of the CTR and its implementing acts.
  • Establish a multi -stakeholder platform, including pati ents, after stakeholder analysis.
  • Implementing GCP modernisation informed by the development of guidance at ICH.
  • Plan and launch a targeted communication campaign to engage all enablers (including data protection experts, academia, SMEs, funders, HTA bodies, healthcare professionals).
  • Reinforce the coordination between scientific advice on clinical trials approval and the design of clinical trials and link to the methodologies working party domain.
  • Deliver a clinical trials training curriculum including modules on drug development and regulatory science with links to universities and SMEs (serving as an educational ‘ecosystem’).

The initiative will build on the application of the Clinical Trials Regulation and launch of the Clinical Trials Information System on 31st January 2022.

To read the full ACT EU initiative paper, see here.

European Medicines Agency (EMA)

EU Clinical Trials Regulation Enters into Application

On 31st January 2022, the EU Clinical Trials Regulation came application, and the new Clinical Trials Information System (CTIS) was launched.

The CTIS is the single-entry point for clinical trial sponsors and regulators to perform submission and assessment of clinical trial data as stipulated in the Clinical Trial Regulation. The CTIS has separate interfaces for sponsors, regulators and member states as well as a public searchable database for healthcare professionals, patients and the general public to access.

The application of the Clinical Trial Regulation and go- live of the CTIS is hoped to strengthen Europe’s position as an attractive location for clinical research, streamlining the application process and supervision of clinical trials.

To read the full EMA press release, see here.


World Health Organisation (WHO)

WHO Release White Paper on the Regulation of Cell and Gene Therapy Products

WHO have issued a white paper proposing a risk-based framework for regulating cell and gene therapy products (CGTPs) to promote global convergence among health authorities.

The white paper outlines the priorities and next steps for advancing global convergence on the regulation of CGTPs, including ATMPs. The key priorities are to:

  • Clearly describe what CGTPs are, describe how the subsets of human cells and tissues (HCTs) and ATMPs are defined from this larger class, providing definitions of key terminology
  • Summarise the existing state of ATMPs that are approved or under development, including examples of challenges in the development and where solutions have been identified
  • Provide the key elements of a regulatory framework that supports the safety and effectiveness of CGTPs including suggested regulatory controls for different risk categories of products
  • Develop a proposal for how the regulatory framework for the risk categories could be implemented in countries with different levels of regulatory maturity
  • Provide an annotated bibliography to highlight key references relevant to the manufacture, product development, and regulation of ATMPs.

To read the WHO report, see here.

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