Last updated: 23 September 2024
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Management of rapid alerts arising from quality defects risk assessment
The document with the above title was adopted on 15 June 2024 and came into forse on 1 August 2024. You can view it here.
Source: EMA
Questions and Answers Document – Regulation (EU) 536/2014 on clinical trials
The document with the above title has been updated. You can view the latest Version 6.9 of July 2024 here. The updates from the previous version are listed on page 2 of the document.
Source: European Commission
Updates to Guidelines on good pharmacovigilance practices (GVP)
The following guidelines have been updated and update details are provided at the beginning of each document.
Source: EMA
Report and minutes from the CMDh meeting held on 23-24 July 2024
The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each meeting and are usually published in the week following the CMDh meeting. The reports therefore only contain a subsection of the complete CMDh agenda and are used for a more timely communication of the most important outcomes.
The CMDh minutes are a full record of the CMDh meetings (minus redaction of confidential content). They are adopted at the following CMDh meeting and subsequently published.
The report and minutes from the above meeting includes (but are not restricted to) the following items:
1. Active Substance Master File worksharing
Further to the update of the document “The worksharing procedure for the assessment of Active Substance Master File (ASMF)”, the CMDh agreed an update of the “EU ASMF number request form”.
- The main change is the request for additional information to check the eligibility of already approved ASMFs (with an assessment history of at least 2 years) to be included in the ASMF worksharing procedure.
- The template has been published on the CMDh website under “CMD Working Parties/Working Groups > WG on ASMF procedures”.
- Here, you can view the track changed (Oct 2020)and clean (July 2024) versions of the form template.
2. IRIS platform
For all EMA led post authorisation procedures (including procedures involving NAPs, e.g. PSURs, PASS, Referrals, etc.) starting from January 2025 IRIS registration is mandatory. The EMA therefore kindly requests MAHs to check that their procedure contact person has an IRIS account.
- Access can be requested via EMA Account Management System following the instructions available in the IRIS guide for registration and RPIs;
- Useful resources:
- IRIS user guide for applicants
- 13 June 2024 RPM update webinar for MAHs (presentation and recording available on event page)
- Industry RPM FAQ Document
Managing regulatory procedures in IRIS is part of EMA strategy to deliver an end-to-end data-driven process from submission to post-authorisation.
- This transition will enhance automation and efficiency, improve knowledge management and data security, and increase transparency.
- Additionally, it will simplify and standardise processes for MAHs, facilitating the decommissioning of SIAMED (the current EMA case management system).
3. Patients’ and Consumers’ PCWP/and Healthcare Professionals’ HCPWP Working Parties joint meeting
A summary was provided of the most relevant topics discussed at the joint PCWP/HCPWP
meeting in July.
The groups discussed, among other topics:
- the patient involvement in EMA activities
- the update of the QRD template of the package leaflet.
- the concept paper on the revision of the Guideline on risk Assessment of Medicinal Products on Human Reproduction and Lactation,
- the re-initiation of the vaccines outreach strategy and
- European Vaccination Information Portal (EVIP)
The full meeting report, including video recordings, is available on the EMA website.
4. Submission of parallel national variations instead of worksharing
The CMDh discussed a request for variation worksharing instead of parallel national
(grouped) variations.
- The CMDh agreed that the changes to transfer the manufacturing process to a new manufacturing site should be submitted via variation worksharing, for better use of resources and the implementation of a timely harmonised outcome across the EU.
- The worksharing should include MAs in all MSs where the product is authorised, even if the variations are already in an advanced stage (or have been finalised).
- The CMDh noted that harmonisation of the complete initial dossier is not a prerequisite for a worksharing procedure and the use of the variation worksharing procedure is also possible in case module 3 is not harmonised, as long as the proposed outcome of the worksharing procedure applies equally to all involved products.
- A letter will be sent to the MAH
5. Package leaflet improvement project
The EMA informed the CMDh about the ongoing update of the QRD template to improve the
package leaflet, in particular to include a key information section at the beginning of the
leaflet.
- As next steps the QRD group will finalise the proposal.
- There will be public consultation on the proposal before final adoption by the QRD group.
- Finalisation is expected in Q2 2025.
- Following questions from the CMDh, it was confirmed that the key information section has to be in line with the SmPC and cannot contain promotional information.
- It has to be proposed by the applicant together with the other parts of the PL.
- There will also be no change in the order of the information provided in the PL. The new section is supposed to replace the current introductory section.
- As per the current process, all information included in the PL will be reviewed by the rapporteur/RMS and commented by CMS.
- Experience from other regions has shown that patients will read the whole PL and not only the key information section.
- Cross reference to other sections of the PL will be provided in the key information section.
- Once the updated QRD template is finalised an implementation plan will be shared.
- A long implementation timeframe is foreseen.
- The EMA will reflect if the update would have an impact on user testing for already authorised medicinal products.
- It was clarified that the update of the QRD template is not linked to the ePI project, which is considered as a format change, while the current update of the QRD template constitutes a content change.
- More guidance and possibly training modules for assessors will be developed throughout the process.
6. SmPC section 5.1 and EUCAST breakpoints
In May 2024, the CMDh agreed and published a Q&A on how a change to update the SmPC
section 5.1 to include EUCAST breakpoints, i.e. reference to the EMA website, should be
submitted.
- As currently different implementations are proposed by MAHs, the CMDh discussed if the existing breakpoint table in section 5.1 should be kept or replaced by the link to the EUCAST breakpoints published on the EMA website.
- The CMDh agreed that the link to the EUCAST breakpoints published on the EMA website should not only be included in the SmPC section 5.1, but any breakpoint table (same or different) in the SmPC section 5.1 should be replaced or omitted.
- In case a type IA variation is submitted where the applicant has added the link but did not delete the existing breakpoint table, the variation can be accepted, but the MAH should be informed that they should delete the existing breakpoint table with the next variation affecting the product information.
- This does not affect the table with commonly susceptible species, which should remain in SmPC section 5.1.
7. Section 6 of the PSUSA AR templates
The PRAC chair informed the CMDh about the PRAC agreement on the future approach after
the pilot on PSUSA ARs without section 6 “Other considerations”.
The PRAC agreed that section 6 would not need to be re-instated and supported the following approach:
- When sufficient evidence is submitted in a Periodic safety update report single assessments (PSUSA) to conclude on the need to extrapolate the PSUSA outcome from mono-components to FDC or vice versa, a note will be included in section 2 of the PRAC AR.
- The information will be shared with the CMDh for nationally authorised products (NAPs) and EMA PL for centrally authorised products (CAPs).
- The CMDh will then publish information in the CMDh minutes for NAPs to enable NAP MAHs to take action.
- If a drug-drug interaction (DDI) is identified in a PSUSA, this will also be highlighted to the CMDh for NAPs to publish information in the CMDh minutes to prompt MAHs to take the most appropriate action.
- However, information on the interacting active substance will not be included in section 2 of the PSUSA AR as always data for the interacting active substance would need to be submitted and assessed before a recommendation could be agreed.
- The support and views from the SOS WG were taken into account in the final agreed
- approach.
- The approach was also agreed by the CMDh.
- The EMA will update the PSUSA AR templates to add detailed green guidance.
2024 January-June- Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
You can view the stats in this slide deck.
Requirements on submissions for Variations and Renewals within MRP and National Procedures
The requirements document has been updated. Here, you can view the track changed (Jan 2022) and clean (July 2024))versions of the document.
Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National Procedures
The requirements document has been updated. Here, you can view the track changed (Jan 2022) and clean (July 2024) versions of the document.
Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers
This table has been updated. Here, you can view the track changed (May 2024) and clean (August 2024) versions of the table.