June 2022
Real Regulatory Tips and Insights
Please find below a roundup of our weekly Regulatory Tips and Insights from our Regulatory experts on our Real Regulatory LinkedIn page. The tips we published in June 2022 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
Clinical Trials Comparators
Marketing Authorisation Application Form
May 2022
Real Regulatory Tips and Insights
Please find below a roundup of our weekly Regulatory Tips and Insights from our Regulatory experts on our Real Regulatory LinkedIn page. The tips we published in May 2022 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
Clinical Study Reports and the ICH Template
https://database.ich.org/sites/default/files/E3_Q%26As_R1_Q%26As.pdf
Clinical Trials: Substantial Amendments
EMA Guidance on CSR Signatures and Appendices
https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-inclusion-appendices-clinical-study-reports-marketing-authorisation-applications_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-coordinating-investigator-signature-clinical-study-reports_en.pdf
EMA QRD Guidance Documents
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information-reference-documents-guidelines
April 2022
Real Regulatory Tips and Insights
Please find below a roundup of our weekly Regulatory Tips and Insights from our Regulatory experts on our Real Regulatory LinkedIn page. The tips we published in April 2022 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
Clinical Trials : Planning for EU Sites
Submission of Renewals to HPRA
Importing IMPs into GB from an Approved County – End of Transition Period
Last week’s round -up;
25-29 October 2021
Antimicrobial Resistance – expected regulatory implications
Activities of the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) are expected to have regulatory implications. Mentioned within their current progress report are agreements on clinical trial recommendations that will be reflected in updated guidance documents for several different types of bacterial diseases. Also identified for continued collaboration up till 2026 are strategies to improve financial incentives, access, research, and development of antimicrobial drugs, diagnostics, and alternatives. Furthermore, the definitions for multidrug-resistant (MDR), extensively drug-resistant (XDR) and pan-drug-resistant (PDR) bacteria for human infections will be revised.
https://lnkd.in/euK-FM_f
Japan’s PMDA posts English translation of guidelines for bioequivalence studies
Japan’s PMDA has released an English translation of guidelines and questions and answers on bioequivalence studies of generic products.The guidelines cover bioequivalence studies, dissolution tests and other assessments for various dosage forms, including oral immediate release and oral extended-release products. The guideline also features a shorter section on non-oral dosage forms and dosage forms for which bioequivalence studies are waived.
https://bit.ly/RealCMC-3EsokCu
Guidance on good lay summary practice
Guidance on good lay summary practice (GLSP) has recently been published by the European Commission. The guidance provides recommendations on how to prepare, write, translate, and disseminate summaries of clinical trial results in lay language, and was adopted by the expert group on clinical trials in July 2021. Sponsors should note that lay summaries on each clinical trial are a mandatory requirement of the upcoming Clinical Trial Regulation. Relatedly, the guidance highlights mandatory requirements under the regulation, and those which are optional recommendations based on ethical obligations and related best practices.
https://lnkd.in/dzJMMANW
Updates from the EDQM
The EDQM has released the following updates:
• A revised osmolality chapter for public comment in Pharmeuropa. The revised chapter focuses on osmolality reference solutions using sodium chloride that are required for instrument verification. The deadline for comments is the 31st December 2021.
• The Pharmacopoeial Discussion Group is preparing a pilot for global expansion of membership to integrate additional world pharmacopoeias.
• CEP holders are invited to comment on draft monographs published in Pharmeuropa 33.4. The deadline for comments is 31st December 2021.
• CEP holders are invited to update their applications according to the revised monographs published in Ph. Eur. Supplement 10.7 that will be implemented on the 1st April 2022.
https://bit.ly/RealCMC-3nTq1lN
Public consultation on EU pharmaceutical legislation
The European Commission has launched a public consultation on the revision of the EU’s pharmaceutical legislation. The consultation will last until 21st December 2021 and will gather views from stakeholders and the general public. The last review of the EU’s pharmaceutical legislation took place almost 20 years ago and the overarching aims of this revision are: to ensure access to affordable medicines, foster innovation, improve security of supply, adapt to new scientific and technological developments, and reduce red tape. In the consultation, the EC also asks if there are other problems it needs to address.
https://lnkd.in/d6snDbtU
The EMA’s tailored scientific advice offering for biosimilar development will be continued
In its report on the initial pilot offering of tailored scientific advice for new biosimilar development, the EMA has announced that this will be continued as part of regular scientific advice operations. When using the procedure, developers are advised on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available. The service will be capped at a maximum of 2 procedures per month, and the duration is set to 70 days if managed without a discussion meeting or 100 days if such a meeting is needed.
https://lnkd.in/eW6FtBem
Updated Q&A on GMP compliance for IMPs
The European Commission has released an updated Q&A no. 8.4 on the Clinical Trials Regulation 536/2014. The updated Q&A covers the documentation that is required to show compliance of an IMP and AxMP with GMP, which is also outlined in Chapter IX and Annex 1 section F of the CTR:
• No documentation is required for IMPs authorised in the EU (even if not manufactured in the EU).
• For IMPs that are not authorised in the EU and do not have an MA from a third country that is party to ICH, and are not manufactured in the EU, an authorisation referred to in article 61(1) and a QP declaration of GMP equivalence is required. In the latter case, if a Mutual Recognition Agreement (MRA) covering clinical trials is in place with the particular country, the latter declaration is not required if the MRA provides for GMP equivalence already.
• An authorisation according to article 61 of the Clinical trial Regulation is required for all other cases.
• Information regarding the GMP compliance of APIs is not required by the CTR (and can therefore not be required by the Member States concerned).
https://bit.ly/RealCMC-3GpA3n5
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July 2021
Real Regulatory Tips and Insights
The tips we published in July 2021 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
Submissions of Variations to MHRA Using Current EU Forms
Scientific Advice
Clinical Studies & Sponsor Responsibilities
https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
March 2021
Real Regulatory Tips and Insights
The tips we published in March 2021 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
Clinical Trials Comparators
IRIS
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-registration_en.pdf
User Roles in IRIS
https://lnkd.in/dxRmsTG
Variation eApplication Forms
For previous monthly round-ups, you can follow these links:
February 2021 Real Regulatory Tips & Insights Round-Up: https://www.realregulatory.com/february-2021-real-regulatory-tips-and-insights/
January 2021 Real Regulatory Tips & Insights Round-Up: https://www.realregulatory.com/january-2021-real-regulatory-tips-and-insights/
December 2020 Real Regulatory Tips & Insights Round-Up: https://www.realregulatory.com/december-2020-real-regulatory-tips-and-insights/
Last week’s round -up;
15-19 March 2021
EU-UK cooperation
The EMA is collaborating with the UK as per the EU-UK Trade and Cooperation Agreement (Annex TBT2 – Medicinal Products). Under the agreement, the EU and UK recognise the outcomes of GMP inspections carried out by the other party in their territories and may also recognise the outcomes of inspections carried out in other third countries. The products covered by the agreement include marketed medicinal products for human or veterinary use, including marketed biological and immunological products for human and veterinary use, advanced therapy medicinal products, active pharmaceutical ingredients for human or veterinary use and investigational medicinal products.
http://bit.ly/RealCMC-2OC6Tet
CEP holders – Avoiding the rejection of notifications
The EDQM Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 7R corr) lists different notifications and associated conditions for CEP revisions and renewals. Any change that is not classified as a notification or a major change should be classified as a minor change by default (except for editorial changes which are covered by specific guidance in the policy document) to avoid rejection. For revised discussions on impurities in section 3.2.S.3.2, and the submission of nitrosamine risk assessments, minor revisions should be submitted. Changes to the synthesis or to the control strategy that are introduced to reduce or eliminate the risk for the formation of nitrosamine impurities or other mutagenic impurities, should be classified according to the EDQM guideline (i.e. minor, major revision or sister file application).
http://bit.ly/RealCMC-3lhXog3
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February 2021
Real Regulatory Tips and Insights
The tips we published in February 2021 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
Clinical Trials Facilitation Group (CTFG) Guidance for Clinical Trials
Orphan Condition & Orphan Indication in the European Union
Clinical Trials: Substantial Amendments
Clinical Trials: Planning for EU Sites
https://www.hma.eu/ctfg.html
For previous monthly round-ups, you can follow these links:
January 2021 Real Regulatory Tips & Insights Round-Up: https://www.realregulatory.com/january-2021-real-regulatory-tips-and-insights/
December 2020 Real Regulatory Tips & Insights Round-Up: https://www.realregulatory.com/december-2020-real-regulatory-tips-and-insights/
November 2020 Real Regulatory Tips & Insights Round-Up: https://www.realregulatory.com/november-2020-real-regulatory-tips-and-insights/
Last week’s round -up;
15-19 February 2021
MHRA has updated their guidance on managing CTs during this pandemic
The guidance now includes a section on “Management of COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials”. The Sponsor should conduct a specific risk assessment for concomitant use of a COVID-19 vaccine for each IMP and with specific consideration for the trial population. Some trials may also need to consider risk assessment for non-IMPs and/or combinations.
Details in full can be found here: https://lnkd.in/ebfYpNS#IMP
CMDh revised MRP/DCP guidance
The CMDh has released the following revised MRP/DCP and national procedure guidance:
• Requirements on Submissions (number and format) for New Marketing Authorisation Applications within MRP, DCP and National Procedures (tracked).
• Requirements on submissions (number and format) for Variations and Renewals within MRP and National Procedures (tracked).
• CMDh annotated QRD template for MR/DC procedures (tracked).
https://bit.ly/RealCMC-3pEBUed
UK MHRA has updated the fees payable to the MHRA for 2020 to 2021
Update the MHRA fees for marketing authorisations and variations now include the new national procedures following exit from the EU, and the new UK “Orphan Marketing Products” fees, available at the following link: https://www.gov.uk/government/publications/mhra-fees?utm_medium=email&utm_campaign=govuk-notifications&utm_source=508f632b-1ef5-4107-9b4e-1e517df8d2e5&utm_content=daily
UK MHRA has updated some medical device guidance
Guidance on applying human factors to medical devices – The updates are primarily around this guidance applying to Great Britain, changes in references to legislation and the introduction of the new UKCA mark. https://lnkd.in/eFUrS3C Assistive technology: definitions, examples and safe use – Updates include a new section on the regulations in Northern Ireland. https://lnkd.in/ecvbrYm Medical device safety information produced by the MHRA – The MHRA publishes National Patient Safety Alerts (NatPSA) for medical devices and medicines. When an issue does not meet the criteria for a NatPSA, but still needs to be broadcast, MHRA may issue a different type of communication, such as the MHRA device safety information (which if targeted to you requires a response) and manufacturers’ field safety notices (FSNs). https://lnkd.in/en73gfq
EMA timetable for AA of full MAAs for ATMPs
EMA has published a new timetable for Initial (full) MAA under accelerated assessment for ATMPs.
Here is a link to the document: https://lnkd.in/enq9rEa
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January 2021
Real Regulatory Tips and Insights
The tips we published in January 2021 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
Type I Variations – Extract(s) from Guideline
eSubmissions Guidance
Editorial Changes for Centralised Product Information
For previous monthly round-ups, you can follow these links:
December 2020 Real Regulatory Tips & Insights Round-Up: https://www.realregulatory.com/december-2020-real-regulatory-tips-and-insights/
November 2020 Real Regulatory Tips & Insights Round-Up: https://www.realregulatory.com/november-2020-real-regulatory-tips-and-insights/
October 2020 Real Regulatory Tips & Insights Round-Up: https://www.realregulatory.com/october-2020-rrl-regulatory-tips-and-insights/
