Regulatory Round-up - February 2022

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

United Kingdom
Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA Proposal for the Future of UK Clinical Trial Legislation

As presented in the previous CGTC Regulatory Round-up, 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.

This consultation is still open and will run until 14th March 2022.

The public consultation is available here.

EAMS scheme to be introduced into law
The Early Access to Medicines Scheme (EAMS) is a vitally important scheme that gives patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation, when there is a clear unmet medical need. The scheme has been running since 2014 and is now due to be introduced into law.

This follows an open consulation initiated by the MHRA in 2021 and the corresponding analysis.

To read the full press release, see here.

European medicines regulatory network

Adoption of EU common standard for electronic product information

The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information (ePI) on medicines in the European Union (EU). This will pave the way for wider dissemination of the unbiased, up-to-date information on all medicines available to patients in the EU through an ever-expanding range of electronic channels.
The EU ePI Common Standard will support the provision of harmonised electronic information on medicines within the EU and is a step towards improved delivery of information for patients, consumers and healthcare professionals to aid their informed decision-making.

Full press release.
ePI initiative resources.

European Medicines Agency (EMA)
Initiation of DARWIN EU® Coordination Centre

On 9 February 2022, EMA initiated the establishment of the Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®).

The role of the Coordination Centre is to develop and manage a network of real-world healthcare data sources across the EU and to conduct scientific studies requested by medicines regulators and, at a later stage, requested by other stakeholders.

For example, the availability of timely and reliable real-world evidence can lead to innovative medicines becoming more quickly available to patients. Better evidence also supports more informed regulatory decision-making on the safe and effective use by patients of medicines on the market.
To read the full press release, see here.

Update of the EMA Reflection paper on the use of IRTs
EMA updated the Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates; originally EMA/INS/GCP/600788/2011.

It was updated in view of the entry into application of the Regulation (EU) No.536/2014, only to clarify that the removal of expiry dates from the labels is not allowed for clinical trials conducted under the Clinical Trials Regulation.

Updated reflection paper EMA/61464/2022.

European Commission
Release of Annex 21 to Volume 4 – GMP
Importation of medicinal products (approved and investigational) from outside the EU/EEA.

This new annex is due to come into operation by 21 August 2022.

Annex 21

Update to Guideline on the requirements for quality documentation concerning biological IMPs in clinical trials
This Guideline was updated following a public consulation conducted in 2021. Chapter 6 was amended to reflect the Regulation (EU) No. 536/2014.
EMA/CHMP/BWP/534898/2008 Rev. 2

Food and Drug Administration (FDA)
Cellular, Tissue, and Gene Therapies Advisory Committee Meeting
The 71st meeting of the cellular, tissue and gene therapis advisory committee will be held on 10 March 2022. The first part of the meeting will be held as an open session to hear an overview of the research programs in the Gene Transfer and Immunogenicity Branch (GTIB), Division of Cellular and Gene Therapies (DCGT), Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Research (CBER).

The meeting information can be found here.