Latest Regulatory Updates

July 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 - ICH, FDA, EMA, MHRA, EC and NCRI.

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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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

The draft ICH E6 (R3) scientific guideline on good clinical practice (GCP) is now open for consultation. The revised guideline addresses the application of GCP to new trial designs, technological innovations and to strengthen a proportionate risk-based approach of its application for clinical trials of medicines to support regulatory and healthcare decision making.

The consultation period ends 26 September 2023.

Food and Drug Administration (FDA)

With its recommendations to modernize clinical trials, the FDA also issued guidance complementing the revised GCP guidance (ICH E6(R3) highlighted above, this includes draft guidance released in May for comment, proposing recommendations for the implementation of decentralized clinical trials for drugs, biological products, and devices. Comments may be submitted until 01 August 2023.

New level 1 final guidance was released on the Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals. The expanded guidance now also includes pharmaceuticals intended to affect the immune system, biopharmaceuticals, and oligonucleotides. Further information relates to assessing the carcinogenicity risk of immunomodulators, methods to assess the risk for adverse immunostimulation (e.g., cytokine release assays), nonanimal methods for assessing dermal sensitization, approaches for assessing the effects of immunotoxicants on pregnancy, and developmental immunotoxicity.

Final guidance on the Content of Premarket Submissions for Device Software Functions is now available, providing information regarding the recommended documentation sponsors should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The final guidance takes a simplified risk-based approach to help determine the device’s Documentation Level, which is either Basic or Enhanced, and helps to identify the minimum amount of information that would support a premarket submission that includes device software functions. 

The FDA issued final guidance to announce and describe its voluntary pilot program for Center for Drug Evaluation and Research (CDER)-regulated oncology drug products used with certain in vitro diagnostic tests. The pilot is intended to provide transparency regarding minimum performance necessary for the in vitro diagnostic tests used with the oncology drug products enrolled into the programme.

European Medicines Agency (EMA)

The revised guideline is now available on Procedural advice on publication of information on withdrawals of applications for marketing authorisation and variations/extensions to marketing authorisations (27 June 2023, R2). The guideline was updated to align it with the Guide to information on human medicines evaluated by EMA.

See also the updated Practical guidance on the application form for centralised type IA and IB variations (24 May 2023, R5)

Draft guidance released for public consultation: The Concept Paper on the development of a Guideline on the quality aspects of mRNA vaccines addresses the manufacturing process, characterisation, specifications and analytical control, plus definition of active substance and finished product for mRNA vaccines for the prevention of infectious disease.

The consultation ends 30 September 2023.

Use of real-world evidence (RWE) in regulatory decision making

EMA published its review on the experience gained from 30 studies managed via the different pathways for RWE generation conducted between September 2021 and February 2023. The report also includes recommendations for identified opportunities and challenges.

A new factsheet is available on the implementation of the Regulation on Health Technology Assessment, which entered into force in 2022 and applies from January 2025.

Newsletter:  Human medicines highlights – Issue 170, June 2023

Primarily addressed to organisations representing patients, consumers and healthcare professionals, this newsletter provides a summary of key information relating to medicines for human use.

Small and medium-sized enterprise (SME): The SME Office annual report 2022 is now available, featuring key facts and figures of companies that are registered as SMEs with EMA.

European Commission (EC)

The European Commission (EC) has provided guidance on the content and structure of the summary of the summary of the clinical investigation report, with an overview of the expected sections and the extent of the information expected in each of the sections.

The Medical Device Coordination Group revised the Guidance on significant changes regarding  the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD to align it to Regulation (EU) 2023/607 and equivalent IVDR guidance MDCG 2022-2, and to introduce clarifications and examples of what is to be considered as a significant change or not.

The EC also published the implementing Regulation (EU 2023/1194) thereby extending the transitional provision periods for products without an intended medical purpose.

New consolidated versions are available for:

  • Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
  • Regulation (EU) 2017/746 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Medicines and Healthcare products Regulatory Agency (MHRA)

The MHRA has updated its webpages with new medical device related guidance, including:

Plus updated guidance on registration of certain medical devices which are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates.

Advance Notice:

The Health Research Authority (HRA) will shortly launch a two-week call for feedback on a draft unmodifiable financial appendix to model agreements for commercial contract research, which will be added to the UK’s existing suite of model agreements for Commercial contract research studies. The call for comments will be shared in early July, via HRA Now.

National Cancer Research Institute (NCRI)

The NCRI, a UK wide partnership between cancer research funders, has announced that it will be winding down after 22 years because of the risk of “operational failure” due to the uncertainty in the wider economic and research environment.
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