February 2023
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 February 2023 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

 

Digital Application Dataset Integration (DADI) project – web-based variation form for human medicinal products launching in October 2022

The European Medicines Agency will launch the electronic application form (eAF) variations web form in October 2022 – this will be the first release of a web-based variation form for human medicinal products, and will be limited to centrally authorised products at go-live. A subsequent release of the form in March 2023 will cover all types of European variations procedures. Further details are available on the eSubmissions website: https://esubmission.ema.europa.eu/cessp/cessp.htm

 

eTMF Quality Control and Audit Preparation Advice

Don’t wait for notification of Health Authority Audit to begin considering Sponsor Functional QC (SFQC) Checks on your eTMF! Real Regulatory specialises in performing SFQC checks on eTMF. Inadequate or incomplete filing of eTMF documentation can be a cause of major findings in an audit but is easily allayed by consistent and pre-emptive SFQCs.

 

Industry Single Point of Contact (i-SPOC) Registration Required

MAHs should register their Industry Single Point of Contact (i-SPOC) on the EMA IRIS platform by 2 September 2022. The i-SPOC will inform and facilitate rapid communication with EMA about the supply and availability of critical medicines identified in the context of ‘public health emergency’ or a ‘major event’. Registration in IRIS is a two-step process and MAHs should allow 5-10 working days for the process to be completed. EMA has updated the IRIS user guide and published a video demo to support companies with registration. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/availability-medicines#industry-contact-points-for-supply-and-availability-of-critical-medicines-(new)-section https://www.ema.europa.eu/documents/other/iris-guide-applicants-how-create-submit-scientific-applications-industry-individual-applicants_en.pdf

 

 

 

January 2023
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 January 2023 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

 

Importing investigational medicinal products (IMPs) into Great Britain from an approved country – end of transition period

Remember that the holder of an MA, as the person or entity responsible for placing a product on the market, bears the legal responsibility for that product and this cannot be delegated. Where activities such as manufacture are conducted by third parties, an MAH must ensure that they have - and can demonstrate - adequate oversight of these activities.

 

IRIS-Scientific Advice

From October 2020 it has been mandatory to use the IRIS platform when applying to the EMA for scientific advice. Applicants should be aware that, where they wish to apply for follow-up scientific advice and the original advice was given to a different organisation, that organisation needs to transfer the original procedure to the applicant. This is accomplished within IRIS using the process type ‘Transfer of Scientific Advice’; procedures occurring prior to October 2020 should be available for selection within IRIS.

 

Transferring a Research Product Identifier (RPI) in IRIS

For certain types of scientific procedures in the EMA’s IRIS portal, you first need to create an RPI for your research product. Remember that, if the product is subsequently transferred to a new sponsor/owner, you will also need to transfer the RPI to this organisation if they need to create new procedures based on the RPI – for example initial scientific advice or a new orphan designation. Full details are available in the IRIS guide to registration, available at: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-registration-rpis_en.pdf.

 

 

December 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 December 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

 

MA Holder & Delegated Activities

Remember that the holder of an MA, as the person or entity responsible for placing a product on the market, bears the legal responsibility for that product and this cannot be delegated. Where activities such as manufacture are conducted by third parties, an MAH must ensure that they have - and can demonstrate - adequate oversight of these activities.

 

Questions & Commitments from Prior Submissions

For amendments to CTAs and variations to MAs, it’s always worth checking prior submissions for questions or commitments relevant to the current submission. For example, an updated investigator's brochure should always incorporate any comments made by authorities on the previous version, or the comments may be raised as questions or findings on the updated version.

 

EMA QRD Guidance Documents

If you are preparing documents using the EMA QRD templates, remember that there are reference documents available concerning formatting conventions, use of abbreviations, past QRD recommendations etc. These can be found on the EMA website at: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information-reference-documents-guidelines

 

EMA Christmas Closure

EMA Christmas Closure The EMA will close for Christmas from 23rd Dec 2022 – 3rd Jan 2023

 

 

 

November 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 November 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

When preparing a clinical study report, it’s always worth remembering that the ICH E3 structure and content guideline is guidance and not a template, as noted in Q1 of the E3 question and answer document (available at https://database.ich.org/sites/default/files/E3_Q%26As_R1_Q%26As.pdf). ICH E3 is not an absolute set of requirements and flexibility may be needed depending on the nature of each particular study.

EMA guidance on CSR signatures and appendices

Two useful guidance documents for CSRs are available on the EMA website, which cover inclusion of appendices to CSRs in MAAs (https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-inclusion-appendices-clinical-study-reports-marketing-authorisation-applications_en.pdf), and designating the coordinating investigator signature of CSRs (https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-coordinating-investigator-signature-clinical-study-reports_en.pdf).

Clinical Trial Comparators

Do you have comparator drugs in your EU clinical trial? Keep section D of your initial Clinical Trial Application form as open as possible. If your protocol allows, it is possible to identify comparators via active substance or INN, and not specify the manufacturer or marketing authorization holder on the form. Maintaining this flexibility may allow you to change supply during the trial, without needing to submit an amendment to authorities.

Clinical Trials: Planning for EU sites

If you are planning to run a clinical trial in the EU, check the Clinical Trials Facilitation Group website (https://www.hma.eu/ctfg.html) "key documents list" for the latest guidance. The CTFG guidance is not included in EudraLex Volume 10, but does include important EU guidance on, eg, clinical trials safety, contraception recommendations, and trial management during the COVID-19 pandemic, amongst others.

 

 

October 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 October 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

Clinical Trials: Substantial Amendments

If there is no change in the substantial amendment that affects the EudraCT (Annex 1) Form other than the Protocol version number and date, then you should not include an updated EudraCT Form in the submission package.

eVariation eApplication Forms

When applying for a grouping of variations, particularly large groupings, ensure that all the required types of application are selected in Section 1 of the eAF before proceeding to choose the types of changes required in Section 3. Any changes (both the addition and deletion of variation types) made to Section 1 will automatically result in the loss of all changes selected and details entered in Section 3, and Section 3 will need to be completed again from scratch.

Clinical studies and sponsor responsibilities

For a sponsor of a clinical study, it must be remembered that the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor, even if some or all of the tasks associated with conducting the study are outsourced to third parties. Sponsor oversight of a study is a key element of the sponsor’s responsibilities under ICH E6(R2) (available at https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf)

Submission of renewals to HPRA

Based on the most recent update of the HPRA Guide to Renewal of Marketing Authorisations: - Products authorised under Directive 2001/83/EC may follow a shortened renewal procedure, i.e. a 30-day timetable under certain circumstances. The applicant should submit a cover letter and an application form (without annexes) with a declaration that full documentation will be available for submission upon request. Changes to MA particulars will not be accepted during the shortened renewal procedure. - It is no longer necessary to submit product information at the end of the renewal procedure unless minor editorial changes are being introduced. In these cases revised product information should be submitted as the agreed national text

 

 

September 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 September 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

New Role in IRIS

New role in IRIS: The EMA is developing a new role within IRIS for orphan drug designations, called IRIS Industry Global Coordinator. Anyone assigned this role will be able to create, view, edit, submit and withdraw ANY application associated with their Organisation, whether or not they have been added explicitly to the submission. The EMA anticipates that the new role will go live in Q1 2022.

eAF for Variations and the Classification Guidelines

QPPV Details Update for UK National Licences

For UK national licences, if there have been no changes to the identity, location and contact details of the responsible QPPV from those entered in XEVMPD at the end of 13 December 2020, and you do not anticipate any changes, these details still need to be notified to the MHRA by 30 June 2022. Full details are available at: https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf#notification-of-qppv-and-psmf-details-to-the-mhra-by-existing-holders-of-uk-marketing-authorisations.

MHRA to retire eSUSAR Website

The MHRA is retiring the eSUSAR website used for the submission of suspected unexpected serious adverse reaction (SUSAR) reports from Clinical Trials of Investigational Medicinal Products (CTIMP). The website will be decommissioned at the end of September 2022, and only SUSARS submitted via the ICSR Submissions portal will be accepted from 01 October 2022. Further details are available on the MHRA Inspectorate blog: https://mhrainspectorate.blog.gov.uk/2022/08/03/decommission-of-esusar/

EU CTIS – Part II Doc Required for Part I Only Submission

f you are preparing a clinical trial authorisation application in the EU Clinical Trials Information System (CTIS) portal, where the dossier is limited to Part I of the assessment report, please be aware that, at present, you need to include the Part II document confirming that the sponsor will collect and process data in compliance with Union Law on Data Protection (item R in Annex I to Regulation (EU) No 536/2014); otherwise it’s not possible to submit the application in CTIS

 

August 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 August 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

EMA eSubmission Gateway Web Client-Upgraded Syncplicity Portal

The EMA eSubmission Web Client portal has been upgraded to the Axway Syncplicity portal. Applicants will need to access the new portal to send submissions to the EMA; previously registered users should have received a password reset link from Axway Syncplicity by e-mail. Guidance on using the Syncplicity portal is available on the eSubmission website:

Clinical Studies & Sponsor Responsibilities

For a sponsor of a clinical study, it must be remembered that the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor, even if some or all of the tasks associated with conducting the study are outsourced to third parties. Sponsor oversight of a study is a key element of the sponsor’s responsibilities under ICH E6(R2)

Mandatory Use of OMS in eAF for all EMA Submissions

From the end of September 2021, new sites and organisations to be registered for a medicinal product as part of any procedure submitted to the EMA (e.g. initial application, line extension, variation, renewal), must be registered beforehand in the Organisation Management Service (OMS) for use in the electronic application form (eAF) (for further details please see http://esubmission.ema.europa.eu/index.htm). Applicants will be requested to register missing sites during validation, which could then delay the start of the procedure.

 

July 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 July 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

MA & Variation eApplication Forms

Questions and Commitments from Prior Submissions

Variation eApplication Forms

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

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