Regulatory Intelligence Digest - July 2022
Latest Regulatory Updates
July?2022
We are back this month with the latest guidance and updates from the regulatory agencies - FDA, EMA, EC, MHRA, and HRA.
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)
Guidance: The FDA published?draft guidance document: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
The guidance outlines a standards recognition program for regenerative medicine therapies (SRP-RMT)?at FDA’s Center for Biologics Evaluation and Research (CBER) designed to recognise Voluntary Consensus Standards (VCS) to enhance the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. Using the recognised VCS?will support stakeholders in more efficiently meeting regulatory requirements and increase regulatory predictability for RMT products.?Read more.
Comments can be submitted until 14 September 2022
The FDA unveiled?its?Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS)
The action plan?outlines?a five-year strategy for improving and extending the lives of people living with rare neurodegenerative diseases by advancing the development of safe and effective medical products and facilitating patient access to novel treatments.?Read more.
Policies and Procedures: The FDA published?a new Manual of Policies and Procedures (MAPP): MAPP 5223.6: Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA
The MAPP purpose is to inform how?the Office of Generic Drugs (OGD) and the Office of Surveillance and Epidemiology (OSE) will assess the user interface of a drug-device combination product (generic combination product). The manual of policies and procedures will apply to all generic combination products.?Read more.
Guidance: The FDA published?draft guidance document: Q9(R1) Quality Risk Management
The ICH Q9 framework, as well as the official ICH training material that supports this guideline, are instrumental in the application of effective quality risk management in the pharmaceutical industry?and by regulators.?Read more.
Comments can be submitted until 15 July 2022
The FDA issued a proposed rule titled, “Nonprescription Drug Product with an Additional Condition for Nonprescription Use”
The proposed requirements are?intended to broaden the range of marketed nonprescription drugs available to consumers, empowering them to self-treat certain common conditions and improving public health.?Read more.
European Medicines Agency (EMA)
Guidance: The?EMA published a?Q&A document for complex clinical trials
The Q&A document?purpose is to provide guidance and assist sponsors, clinical trialists and applicants regarding scientific aspects and the planning, set-up, submission for obtaining CT authorisation (CTA), conduct, reporting and transparency, analysis and interpretation of complex clinical trials (CCTs) under the EU Clinical Trials Regulation (EU CTR) as well as their use in submissions for marketing authorisation.?Read more.
Medical devices: Updates to the EMA Medical Devices overview pages
Several updates have been made to the EMA section on medical devices?such as the Questions & Answers for applicants, marketing authorisation holders of medicinal products, and notified bodies concerning?the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) and arrangements for companion diagnostics.?Read more.
News:?First gene therapy to treat severe haemophilia A
The first gene therapy to treat severe haemophilia A, Roctavian?(valoctocogene roxaparvovec) has been recommended?granting a conditional marketing authorisation in the European Union (EU) by the EMA, Roctavian (valoctocogene roxaparvovec) is for the treatment of severe haemophilia A in adults who do not have factor VIII inhibitors (auto-antibodies produced by the immune system which make factor VIII medicines less effective) and no antibodies to adeno-associated virus serotype 5 (AAV5).?Read more.
EMA notifies of a?number of events on the Clinical Trials Information System (CTIS)
Clinical Trials Information System (CTIS) bitesize talk: Notifications - Part 2?, Online, 14:30 - 16:00 Amsterdam time (CEST), from 20/10/2022 to 20/10/2022
Clinical Trials Information System (CTIS) sponsor end user training programme - November 2022?, Online, 14:00 - 18:30 Amsterdam time (CET), from 07/11/2022 to 10/11/2022
Clinical Trials Information System (CTIS) sponsor end user training programme - September 2022?,?Online, 09:00 - 13:30 Amsterdam time (CEST), from 20/09/2022 to 23/09/2022
Clinical Trials Information System (CTIS) bitesize talk: Transitional trials and additional Member State concerned (MSC) application?, Online, 14:00 - 15:30 Amsterdam time (CEST), from 23/06/2022 to 23/06/2022?
List of Union reference dates and frequency of submission of periodic safety update reports (PSURs)?Read more.
Report: Data quality framework for medicines regulation
The report was released following the workshop on Data Quality Framework for medicines regulation.?Read more.
Referrals document:?Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products.?Read more.
Update to Quality of medicines questions and answers: Part 2 Replacement/removal of titanium dioxide (TiO2) in medicines.?Technical and procedural guidance.
Outlines steps MAA holders need to consider in regards to Commission Regulation (EU) 2022/63 of 14 January 2022 amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the food additive titanium dioxide (the Regulation) entered into force following its publication in the Official Journal of the European Union on 18 January 2022. The Regulation is applicable to all medicinal products containing TiO2 independent of its pharmaceutical form.?Read more.
Guidance on variation applications for updates of vaccine composition for centrally authorised vaccines against COVID-19 disease updated
Regulatory and procedural guideline for variant,?read more.?
Industry Standing Group (ISG) meeting
The industry stakeholders group (ISG) has been established as a new forum for interactions as part of the EMA continuous improvement of industry stakeholders engagement (in line with its industry stakeholders framework). This will facilitate regular exchange of views, promote dialogue and receive feedback.?Read more.
Guidance – centralised procedures:
The following two EMA Question and Answers (Q&A) documents were updated in June 2022
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Guidance: IRIS
An updated Guide for applicants - How to create and submit scientific applications, for industry and individual applicants is available?here.?(version 2.10, 16 May 2022)
Guidance: Orphan Medicinal Products (OMP)
The EMA has updated the checklist for sponsors applying for the transfer of OMP designation, as well as the template for translations required with the submission of an application for such transfer.?Read more.
Guidance: Procedural advice for post-OMP designation activities
Updated on 25 May 2022 (General text and format update).?Read more.
Newsletter: Human Medicines Highlights - June 2022.?Read more.
Events: Patients and Consumers’ (PCWP) and Healthcare Professionals’ (HCPWP) Working Parties
The first joint meeting of the new mandate (2022-25) of the ‘Patients and Consumers’ (PCWP) and ‘Healthcare Professionals’ (HCPWP) Working Parties was recently held. Presentations are now available?here.
News: Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability
Industry Single Point of Contact (i-SPOC) is now open for?Marketing authorisation holders (MAHs) to register.
This will require?(MAHs)?to inform the?EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major event’.?Read more.
European Commission (EC)
Commission release Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications following Regulation (EU) 2017/746
The Commission has adopted common specifications for several types of high-risk diagnostics (Class D), such as HIV tests and SARS-CoV-2 tests. The specifications set uniform and rigorous benchmarks for tests across the EU, clarifying the requirements for market actors and protecting EU patients.?Read more.
Medical Device Coordination Group:?MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements
MDCG has?issued a reminder to all manufacturers that in order to ensure that devices can continue to be placed on the EU market and to avoid shortages of medical devices, it is essential that all manufacturers adjust their system, finalise transition to the MDR and apply to a notified body, submitting complete and compliant applications, as soon as possible and well in advance of the end of the transition period to ensure timely compliance with the MDR.?Read more.
Medicines and Healthcare products Regulatory Agency (MHRA)
News:?Funding for clinical research to speed up research and increase cutting-edge treatments for patients.
The second phase of the UK government plan to achieve the vision for 'The Future of UK Clinical Research Delivery' was announced in June.
This included ￡150 million of additional funding from the?NIHR (National Institute for Health and Care Research)?and ￡25 million in additional funding from other delivery partners in the UK Clinical Research Recovery, Resilience and Growth Programme.?Read more.
Guidance:?MHRA has published updated Marketing Authorisation Application (MAA) submission dates for 150-days national and European Commission decision reliance procedures
Submission deadlines up to 04 March 2024 are now available.?Read more.
Update: Application dates for the early access to medicines scheme (EAMS), dates up to 06 November 2023 are now available?Read more.
Press release:?MHRA joins international partnerships to set global standards for medicines and medical devices regulation
The MHRA has announced its new membership in?three international work-sharing partnerships. This means the UK will play a greater international role in ensuring medicines and medical devices are regulated safely and efficiently worldwide.?Read more.
Consultation on the future regulation of medical devices in the United Kingdom
The MHRA has published a consultation outcome for the future regulation of medical devices in the UK.?Read more.
Press release:?Health impact of potential bias in medical devices
Review launched into the health impact of potential bias in medical devices.?Read more.
Open consultation:?UK’s future strategy for batch testing of medicinal products
A consultation on a future strategy for batch testing medicinal products in Great Britain has been launched by UK Government. The consultation will gather views and opinions on four policy options for batch testing where medicines are imported into Great Britain from third countries that do not have a mutual recognition agreement with the UK (which includes all EEA countries). The consultation will help to shape the development of the strategy.?Read more.
Consultation closes 26 July 2022.
Update:?Guidance for The Conversion of PLGB or PLNI licences to PL.?Read more.
Health Research Authority (HRA)
Consultation: 'Think Ethics -?have your say on ethics review for health and social care research'
The HRA, working with partners in Scotland, Wales and Northern Ireland, has launched a public conversation about how research ethics review could be changed to make it better for researchers, ethics committee members and people taking part in research.?Read more.
The consultation runs until 23 September 2022.?