REGULATORY PUBLIC DISCLOSURE (RPD) - January 2023
Medicines and Vaccines
- Free Webinar on 26 January 2023: New ICH M11 Harmonised Guideline and Protocol Template
The ICH M11 Expert Working Group (EWG) is holding a free public webinar, convened by CTTI, to describe the latest developments on the ICH M11 Guideline. The webinar is taking place on Thursday, 26 January 2023 from 10:00-12:00 EST. Registration is open, and participants are invited to submit questions about this webinar in English using this form by Friday, 20 January 2023. Click here to register.
The webinar will include the following speakers from the ICH M11 committee:
- Janice Maniwang, U.S. Food and Drug Administration (FDA)
- Noémie Manent, European Medicines Agency (EMA)
- Mitzi Allred, Merck
During the webinar, these speakers will describe the latest developments on the M11 Guideline, Protocol Template, and Technical Specification; explain the benefits and opportunities created by the M11 Protocol Template; explain how the Protocol Template was developed; and explain the purpose of the technical specifications in supporting the exchange and storage of clinical trial data. There will also be a Q&A session at the end of the webinar during which the speakers will address a selection of questions submitted during registration.
2. Version 2.0 (17-Jan-2023) of the CIOMS Glossary of ICH Terms and Definitions was published and is freely available here. The glossary combines the terms and definitions included in the guidelines of the ICH.
CTR and CTIS
- Save the date: CTIS Event on 20 January 2023
A public CTIS Event on Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023 is taking place on Friday, 20 January 2023 from 10:00–13:00 CET. Participants can ask questions in advance, from 9 - 16 January 2023, via the audience interaction tool Slido. Please go to www.sli.do and enter the event code “#CTIS2023”.
A factual summary of the EU Survey (conducted 18 July until 9 September 2022) to collect feedback from sponsors and stakeholders to identify possible hurdles for implementation of the CTR has been published (“Targeted consultation on the implementation of the Clinical Trials Regulation (EU) No 536/2014”). In total, 62 sponsors and other stakeholders provided their views on the new regulatory environment provided by the CTR and their experience with CTIS. According to the report authors, “The reported experience does not necessarily reflect the current status of CTIS user experience and the CTR implementation. Many of the issues reported have been addressed in the meantime via resolution of the encountered defects and new functionalities in CTIS, alignment of national legislation, additional guidance material for sponsors, as well as targeted modification of the rules of the CTR by a delegated act”.
Based on the EU survey results, a new version of frequently-asked 'questions and answers' regarding the implementation of the rules on clinical trials was released in Dec 2022 (CTR (EU) No 536/2014 Q & A V6.3). Changes and updates compared to the superseded version are outlined in the document history on the front page and importantly include the creation of a new Annex III detailing websites where sponsors can find national requirements to submit high quality Part II documents as part of their clinical trial applications.
In December 2022, EMA issued Version 3.01 of the “CTIS Sponsor Handbook”. This version provides:
- updated timelines for due dates in CTIS
- updated information on document upload sizes
- clarifications of dates for the transition period
- A recording of the ICH public webinar entitled “New ICH M11 Harmonised Guideline, Protocol Template, and Technical Specification,” held on 26 Jan 2023 is available to download.
UK and MHRA News
The UK is on track to become the first country to finally fix the problem of unreported clinical trials. In future, the UK ethics regulator will directly register all trials immediately after they receive ethics approval, and will later check whether their results were made public, ending research waste once and for all. How the UK is ending research waste - explained in 153 words.
FDA Guidance and News
- In January 2023, the FDA released the final Risk Evaluation and Mitigation Strategy (REMS) Document Technical Conformance Guide. The guide provides updated, detailed instructions on the format of a REMS Document, along with standardised language that describes common REMS requirements to help ensure consistency and facilitate efficient review of the REMS Document.
- The US FDA issued new draft guidance (entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format”) aimed at ensuring that the Dosage and Administration section contains the dosage- and administration-related information needed for safe and effective use of a drug and that the information is clear, concise, and presented in a manner that is pertinent and understandable to health care practitioners (13 January 2023). In the notice announcing the availability of this new draft guidance, FDA also withdrew the guidance for industry Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (March 2010), which formerly provided FDA’s thinking relating to certain information in the Dosage and Administration section. Comments on the new draft guidance are due to be submitted by 15 March 2023.
- In December 2022, FDA issued a new Proposed Rule that would replace the current IND annual reporting requirement with the FDA Development Safety Update Report (DSUR). The FDA DSUR regulation would require sponsors to provide an annual report that is more comprehensive and informative than the current IND annual report, such as an integrated overall safety analysis and a summary of cumulative pertinent safety information.
EMA Guidance and News
- The EMA Management Board: highlights of December 2022 meeting indicates that the EMA will seek to gradually remove business continuity measures that were implemented in the course of the Agency’s relocation to Amsterdam. The report states “the Agency will seek opportunities to gradually reinitiate previously suspended or reduced activities, notably implementing a phased restart of clinical data publication for centrally authorised medicines beyond the scope of COVID-19.” Notably, at this time there is no specific date for the resumption of clinical data publication via Policy 0070.
- The European Commission, the Heads of Medicines Agencies (HMA) and the EMA published recommendations to facilitate the conduct of decentralised clinical trials while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected. The recommendations cover the aspects of roles and responsibilities, informed consent process, delivery of study drugs at home, and trial-related procedures at home.
- European Medicines Agency is working on restarting its policy on publishing clinical trial data, with the first phase expected to start this year. The Agency suspended the publication of clinical data in December 2018 as a result of the implementation of the third phase of EMA's business continuity plan and it remains suspended due to ongoing business continuity linked to the COVID-19 pandemic. The EMA has been publishing clinical data for COVID-19 medicines in line with its exceptional transparency measures for treatments and vaccines for COVID-19.
The restart of the policy will focus on filings for novel drugs.
Transparency and Disclosure Resources and News
TranspariMed is leading a discussion entitled “How can the UK clinical trial transparency system be implemented in other countries?” on January 26th at 2:30pm GMT (3:30pm Berlin time). This live discussion will bring together some of those involved in developing the UK’s system to discuss how this model could be applied to other regions with a focus on Germany. Participants will be able to submit questions and comment during the discussions. Spaces are limited and registration in advance is via Consilium Scientific.
PHUSE Data Transparency Winter Event 7-9 Feb 2023 is open for registration. The 3 day on-line event takes place 15:00–17:30 (GMT), each day and features live presentations and a joint panel discussion/Q&A session to explore latest developments. The event is free but registration is required. A proposed agenda is available.
News from Asia Regulators
From 01 January 2023, China NMPA requires all documents for drug registration applications, as well as supplemental documents sent during the review to be submitted electronically in compact disks. No paper documents are required and the application documents should be organised in eCTD format.
The Japanese Ministerial Ordinance on Good Clinical Practice for Drugs has been amended: link to translation as of January 2023: Ministerial Ordinance on Good Clinical Practice for Drugs.
Medical devices information is kindly compiled by Raquel Billiones.
EU MDR Updates
- MDR Transition Extended
In early January 2023, the European Commission adopted a proposal to extend the transition periods to the EU MDR and EU IVDR. This will allow more time for the stakeholders to adapt to the new rules, thus mitigating shortages of life saving devices and ensuring continued access for patients. Check out the FAQ here. Under the proposal, device manufacturers will have until December 2027 (instead of May 2024) to recertify previously approved high-risk devices, and till December 2028 for medium and low risk devices.
The MDCG issued a forecast of their upcoming activities in 2023.
Updates from the UK
The UK’s MHRA will be holding a webinar on 24 January 2023 with the following draft programme:
- Future Medical Devices Regulations: overview of current status and future milestones - Penny Wilson, Deputy Director Innovative Devices, MHRA
- The next regulatory milestones in detail: the Statutory Instruments to be laid in Spring 2023 and Summer 2024 - Jillan Hussein, Devices Regulatory Specialist, MHRA
- Developing guidance for the future regulations: an update on the work of 13 focus groups and our commitment to ensure meaningful patient involvement - Catherine Hodgson, Regulatory Affairs Specialist, MHRA
- An update on approved bodies, domestic assurance and supply chain - Suzanne Fuller, Head of Approved Bodies, MHRA
Updates from the US
The US Congressional Research Service just published a new report on the US FDA regulation of medical devices.
Updates from the Notified Bodies
The Notified Body BSI is organising the Series 2 Clinical Masterclass on Medical Devices starting 11 January 2023. The 5-part series will focus on five key clinical documents: the Clinical Evaluation Plan; Clinical Evaluation Report; Post Market Clinical Follow Up Plan; Post Market Clinical Follow Up Report; and the Summary of Safety and Clinical Performance.