Latest Regulatory Updates

February 2023

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

To discuss any of these updates please contact a member of the Boyds Regulatory team who will be happy to help.

Food and Drug Administration (FDA)

Update on In-Person, Face-to-Face Formal Meetings with FDA
Beginning 13 February 2023, CDER and CBER will restart in-person, face-to-face industry meetings, starting with Type A, Type 1 meetings on stalled development programmes, and Type X meetings. Other types of face-to-face meetings will be held only virtually.

GMP inspections: FDA signed a Mutual Recognition Agreement (MRA) between the US and Switzerland, allowing the FDA and Swissmedic to share each other's GMP inspection findings, building on its existing MRAs with the European Union (EU) and United Kingdom (UK).

Center for Devices and Radiological Health (CDRH)’s 2022 Annual Report outlines the Center’s accomplishments, including CDRH By the Numbers, Pandemic Response, MDUFA V, Device Innovation, and Device Safety.

CDER’s 2022 Annual Report highlighting new drug approvals spotlights notable treatments. See also CBER’s webpage for 2022 Biological Product Approvals for information on these actions.

Final guidance released: Format and Content of a risk evaluation and mitigation strategy (REMS) document for prescription drug products, including biological drug products, and the REMS Document Technical Conformance Guide.

Draft guidance on dose optimisation in oncology assists in identifying the optimal dosage(s) for human prescription drugs or biological products for the treatment of oncologic diseases during clinical development and pre-New Drug/Biologics License Application.

Draft guidance released for public consultation on Considerations for the Design and Conduct of Externally Controlled TrialsThis guidance focuses on the use of patient-level data from clinical trials or from real-world data sources such as registries, as well as electronic health records and medical claims. Consultation ends 02 May 2023.

Draft Guidance: The FDA announced it is proposing a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV (similar to policies in place in e.g. the UK and Canada).

Draft guidance released for public consultation
on Monkeypox virus: Development of Drugs and Biological Products. This guidance provides nonclinical, virology, and clinical considerations for monkeypox drug development programs, with a focus on recommendations to support initiation of clinical trials. Consultation ends 21 March 2023.

Funding opportunity to support paediatric medical device development: The Pediatric Device Consortia grants program is now open until 29 March 2023. FDA intends to support these awards for five years. See the request for applications for funding details and how to apply.

European Medicines Agency (EMA)

Clinical Trials Information System (CTIS):

A new guidance document has been published for sponsors: Questions and answers on the protection of commercially confidential information and personal data while using CTIS.

New scientific guideline: ICH guideline Q13 on continuous manufacturing of drug substances and drug products – Step 5 describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing and is legally effective from 10 July 2023.

Revised guideline: The Committee for Medicinal Products for Human Use (CHMP) adopted the Guideline on clinical evaluation of vaccines, Revision 1, 16 January 2023.

New pilot scheme for devices: EMA is launching a pilot to provide scientific advice to manufacturers of certain high-risk medical devices, specifically class III medical devices and class IIb active medical devices intended to administer or remove medicinal products to/from the body. The Agency will accept letters of interest for participation in the pilot from end of February 2023.

European Innovation Council (EIC) – EMA Info Day:

The recording from the 31 January meeting, which provided an overview of regulatory support for the development of innovative medicines and technologies, is available.

Marketing Authorisations (MAs): The following websites and associated documents were updated in December 2022:

Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA

Newsletter: SME Office – Issue 57, January 2023

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

Newsletter: Human medicines highlights Issue 165, January 2022

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

EMA released its Final Programming Document 2023-2025, which summarises the Agency’s activities and objectives for the stated period.

Medicines and Healthcare products Regulatory Agency (MHRA)

Press release: UK to introduce first-of-its-kind framework to make it easier to manufacture innovative medicines at the point of care. The new framework looks to remove regulatory barriers to innovative manufacturing to support manufacture of e.g. products with very short shelf lives, and highly personalised medicines can easily be made in or near a hospital setting or ambulance to expedite patient access.

Press release: MHRA increases UK assessment capacity for in vitro diagnostic devices.  An additional approved body has been added for in vitro diagnostic (IVD) devices, increasing the UK’s capacity to process conformity assessments.

Devices: European Commission Decision Reliance Procedure (ECDRP)

MHRA extended the ECDRP to 31 December 2023. From 1 January 2024, a new international recognition framework will be in place. Before 31 December 2023, where a CHMP positive opinion has been received, applicants can continue to submit ECDRP Marketing Authorisation Applications or variations to MHRA and they will be reviewed via the current ECDRP process.

Good Clinical Practice (GCP) Inspections: An updated version of the GCP inspection dossier clinical trial spreadsheet is available.

Brexit: The UK government publishes a Retained EU law (REUL) dashboard listing the EU laws the UK saved to ensure legislative continuity after Brexit. The most recent update identifies over 1,000 additional pieces of REUL, concentrated over 400 unique policy areas.

Case study: MHRA’s Innovation Accelerator service includes a focus on the identification of Actionable Horizon Scanning Signals (for an example see this new case study).

European Commission (EC)

Clinical Trial Regulation: A new quick guide on the main rules and procedures of the EU Clinical Trials Regulation is available: Clinical Trials Regulation (EU) No 536/2014 in practice.

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