Latest Regulatory Updates

August 2023

Hello and welcome back to the Boyds Regulatory Intelligence Digest. This month we are sharing the latest guidance and key updates from the regulatory agencies - FDA, EMA, MHRA, and ICH.

To discuss any of these updates, please contact a member of the Boyds Regulatory team who will be happy to help.
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Food and Drug Administration (FDA)

Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products (CGTs)

FDA released new draft guidance discussing the management and reporting of manufacturing changes for CGT products based on a lifecycle approach, and on comparability studies to assess the effect of manufacturing changes on product quality.

FDA Mutual Recognition Agreement (MRA) with Swissmedic enters into force

Both agencies can now rely on each other’s factual findings from a good manufacturing practice (GMP) inspection of a pharmaceutical manufacturing facility. FDA MRAs are also in effect with the European Union and the United Kingdom.

European Medicines Agency (EMA)

Transitioning trials from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR)

A new guidance was released on Transition of clinical trials from CTD to CTR. This Guidance supersedes the chapter 11 of the Questions & Answers on the application of the EU Clinical Trials Regulation (version 6.4).

Additional guidance advises Sponsors of multinational clinical trials with different protocol versions approved in different Member States to follow the Best Practice Guide and cover letter template when transitioning their trials from CTD to CTR.

EMA issued a draft reflection paper on the use of artificial intelligence (AI).

This paper is open for public consultation and reflects on principles relevant to the application of AI and machine learning at any step of a medicines’ lifecycle, from drug discovery to the post-authorisation setting.
Consultation ends 31 December 2023

Coordinated clinical trials in public health emergencies

EMA published a report on lessons learned on Clinical Trials (CTs) in Public Health Emergencies. This highlights the need to improve the way CTs are set up and conducted in the EU during crisis times to ensure that sufficient evidence is rapidly gathered from adequately sized clinical trials across multiple Member States to support rapid access to treatments and vaccines.

Phasing out of extraordinary COVID-19 regulatory flexibilities

The World Health Organsiation (WHO) declared an end to the COVID-19 public health emergency in May 2023. As a result the EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are now phasing out the extraordinary regulatory flexibilities for medicines put in place during the pandemic to help address regulatory and supply challenges arising from the pandemic.

On-site good manufacturing practice (GMP) and good distribution practice (GDP) inspections have already restarted, however, because of the  considerable number of postponed inspections the validity of GMP and GDP certificates has currently been extended until the end of 2023, and the GMDP Inspectors Working Group will issue in the coming months an update on the approach for 2024.

The following two regulatory and procedural guidelines contain multiple updates:

For a centralised procedure there is a single application, a single evaluation and a single authorisation throughout the European Union. Only certain medicines are eligible for the centralised procedure.

Newsletter: SME Office – Issue 59, July 2023

The bulletin highlights news, documents, and activities of interest to SMEs and their stakeholders.

Newsletter: Clinical Trials Highlights – Issue 15, July 2023

Provides the latest news on clinical trials from the European Medicines Regulatory Network (EMRN), including news on the joint Accelerating Clinical Trials in the EU (ACT EU) initiative and on the Clinical Trials Information System (CTIS).

Medicines and Healthcare products Regulatory Agency (MHRA)

Implementation of future Regulations

The Government released regulations (The Medical Devices (Amendment) (Great Britain) Regulations 2023) that enable CE marked medical devices to be accepted in Great Britain for defined periods beyond 30 June 2023. MHRA guidance has been updated to reflect this change and includes an infographic of the updated timelines. 

Unless an exemption applies, all In Vitro Diagnostic Medical Devices (IVDs) placed on the market or put into service in the UK are required to have the relevant mark of conformity (UKCA, CE or CE UKNI).

This includes IVDs used in clinical trials of medicines (CTIMP). To support applicants MHRA updated its webpages on Clinical trials for medicines: apply for authorisation in the UK with a new section on IVDs.

The Agency also offers a new coordinated assessment pathway in partnership with the Health Research Authority (HRA) to streamline the review of clinical investigations involving medical devices, see here how to participate.

UK Government announces extension of CE mark recognition for businesses

The Department for Business and Trade announced an indefinite extension to the use of CE marking for UK businesses beyond 2024 deadline.

Labelling and packaging of medicinal products for human use

Following agreement of the Windsor Framework, new guidance provides information on the implementation of labelling and packaging requirements for the supply of medicines into Northern Ireland. Coming into effect on 01 January 2025, all medicines on the UK market must be labelled as ‘UK Only’. This ensures the same packaging and labelling across the UK and precludes onward movement of these medicines into any part of the European Union (EU).

HRA launched a One-stop-shop for artificial intelligence and digital regulations, offering centralised, curated and up-to-date regulatory content for both developers and adopters of AI and data-driven technologies, and access to specialist support.

International Council for Harmonisation (ICH)

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