Regulatory Intelligence Digest - September 2022
Latest Regulatory Updates
September 2022
We are back this month with the latest guidance and updates from the regulatory agencies - FDA, EMA, EC, MHRA, HRA, ICH and FPM.
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)
Global Perspective:?“How a European Data Law is Impacting FDA”
New web page:?FDA announced the publication of a new web page sharing the agency’s most recent actions and activities related to complex generics.
Release of Final Guidance:?“FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products”
This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Release of Final Guidance:?“General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products”
Release of Draft Guidance:?“Electronic Submission of Expedited Safety Reports from IND-Exempt BA/BE Studies”
In the past, SAEs from IND-exempt BA/BE studies have been reported directly to FDA’s Office of Generic Drugs by email, telephone, or fax using Form FDA 3500A. Enhancements to FAERS will allow electronic submission of SAEs from IND-exempt BA/BE studies. This guidance includes recommendations for submitting an SAE in the ICSR to FAERS as an alternate avenue.
(Closing date for comments: 03?October 2022)
Release of Draft Guidance:?“Charging for Investigational Drugs Under an Investigational New Drug (IND) - Questions and Answers”
This draft guidance responds to frequently asked questions about FDA’s processes, policies and regulation regarding charging patients for investigational new drugs under certain circumstances in clinical trials or expanded access for treatment use. When finalized, this guidance will replace the 2016 guidance.
Significant changes to the 2016 version include additional recommendations related to the need for submission of a statement by an independent certified public accountant under certain circumstances and distribution of the manufacturing, administrative, or monitoring costs from the first year over the expected duration of the expanded access IND or protocol.?
(Closing date for comments: 24 October 2022)
Release of new Draft Guidance:?“E11A Pediatric Extrapolation”
This guideline provides recommendations for, and promotes?international harmonization of, the use of pediatric extrapolation to support the development and authorization of pediatric medicines.
Online Public Science Symposium:
The purpose of the symposium is to discuss scientific topics related to the regulation of biologics and highlight science conducted at CBER by showcasing how scientific research informs regulatory decision-making, and to provide a forum for developing collaborations within FDA and with external organizations.
Dates and times:
Tue, Sep 20, 2022, 12:00 PM –
Thu, Sep 22, 2022, 4:00 PM EDT
European Medicines Agency (EMA)
News:?EMA issued a statement that they are experiencing delays in processing scientific advice requests.
Applicants can contact the Agency for more information on expected timelines before submitting a request, by writing to:?[email protected].
News:?“Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan”
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) published the “2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU)”.
The initiative builds on the Clinical Trials Regulation (CTR) and Clinical Trials Information System's (CTIS) launch on 31 January 2022. It aims to deliver on the clinical trial innovation recommendations of the European medicines agencies' network strategy and the European Commission’s Pharmaceutical strategy for Europe.?Read more.
Newsletter: Human medicines highlights – August 2022
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Regulatory and procedural guideline:
The?EMA EudraVigilance Registration Manual?has been updated.
Clinical Trials Information System (CTIS) bitesize talk:?“Notifications - Part 1”?
Date: 28 September 2022, online
This bitesize talk on CTIS provides an opportunity for sponsors to learn about the notifications related to trial and recruitment period, e.g. start, end, restart and halt of trial etc. Sponsors will also have the opportunity to ask questions on this CTIS topic during the event.?Read more.
CTIS bitesize talk:?“Transitional trials and additional Member State concerned (MSC) application”
The video recording of this event held in June 2022 is now available.
Multi-stakeholder workshop:?“Patient experience data in medicines development and regulatory decision-making”
Date: 21 September 2022 @ EMA Amsterdam?- The recording of this meeting will be made available after the event.
For more information and the agenda?see?here.
European Commission (EC)
Guidance:?The revised Annex 1 to Eudralex Volume 4 has been published:?“The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use – Annex 1: Manufacture of Sterile Medicinal Products”
The deadline for coming into operation of Annex 1 is 25 August 2023, except for point 8.123 which is postponed until 25 August 2024
Medicines and Healthcare products Regulatory Agency (MHRA)
MHRA Inspectorate:?“Innovation, Quality & Transparency – a Compliance Team 1 Perspective”
Blog on the MHRA site with a focus on innovation, and where the traditional ‘Quality’ activities and professionals fit within this space. Read more.
Clinical Trials and Investigations
On 30th September 2022, the MHRA will decommission its Suspected Unexpected Serious Adverse Reactions (SUSAR) website in favour for Individual Case Safety Report (ICSR) Submissions.
For more information see SUSAR section here.
And/or
Read MHRA Inspectorate Blog here.
Health Research Authority (HRA)
Blog: “What could be the big issues for research ethics over the next ten years?”
A blog by Juliet Tizzard from the Health Research Authority and Sue Tansey from Nuffield Council.
International Council for Harmonisation (ICH)
Guidance:?“Testing for Carcinogenicity of Pharmaceuticals”
As of August 2022, the ICH S1B(R1) Guideline integrates a new Addendum that expands the evaluation process for assessing human carcinogenic risk of pharmaceuticals by introducing an additional approach that is not described in the original S1B Guideline. Application of this integrative approach reduces the use of animals in accordance with the 3R (reduce/refine/replace) principles and shifts resources to focus on generating more scientific mechanism-based carcinogenicity assessments, while continuing to promote safe and ethical development of new pharmaceuticals.
The final version of the Guideline is available here(Adopted 04 August 2022)
Faculty of Pharmaceutical Medicine (FPM)
“Patient Engagement in Rare Diseases and Gene Therapy – six top tips for pharmaceutical physicians”