Last updated: 4 April 2023
See updates at the end of the post.
Q&A about the raw data proof-of concept pilot for industry
In July 2022, the EMA launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorisation applications (MAAs) for new medicines as well as post-authorisation applications and to explore the practical aspects of the submission and analysis of such data.
On 7 March 2023, the EMA published a Q&A on the pilot.
‘Raw data’ also referred to as ‘Standardised Study Data’ means individual patient data from clinical studies in structured format from which statistical analyses are derived. Raw data includes the datasets in Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) formats.
The pilot project is open to applicants or MAHs that are about to submit marketing authorisation applications or post-authorisation applications. If selected, they will include raw data already as part of their submissions. More information on the pilot’s objectives and on the terms of participation is available in this document. The pilot:
- is expected to last up to two years and will include approximately ten regulatory procedures submitted to EMA from September 2022.
- will fully comply with data protection legislation requirements.
Source: European Medicines Agency
Product Management Services (PMS) Webinar on data migration
Here is a link to the above webinar held on 23 February 2023
The Product Management Service (PMS) aims to deliver comprehensive and consolidated medicinal product data (on Centrally Authorised Products (CAPs) and Non-CAPs) from different sources.
The updated Chapter 7 of the EU IDMP Implementation Guide (EU IG), released on the EMA website on 18 January 2023, provides information on the approach followed by the European Medicines Agency (EMA) to enable the transformation, migration and availability of authorised product data to the PMS database.
This event was a webinar for industry and national competent authorities’ stakeholders wishing to learn more about data migration activities from SIAMED and xEVMPD databases to PMS
Source: EMA
Guideline on computerised systems and electronic data in clinical trials
This guideline replaces the ‘Reflection paper on expectations for electronic source data and datatranscribed to electronic data collection tools in clinical trials’ (EMA/INS/GCP/454280/2010).
- Final version of the guideline was adopted by the GCP IWG on 7 March 2023
- Date of coming into effect is six months after publication.
This guideline describes some generally applicable principles and definition of key concepts. It also covers requirements and expectations for computerised systems, including validation, user management, security, and electronic data for the data life cycle. Requirements and expectations are also covered related to specific types of systems, processes, and data.
Source: European Medicines Agency
Report and minutes from the CMDh meeting held on 21-22 February 2023
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 include (but are not restricted to) the following items:
1. Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures
With a view to simplifying regulatory procedures, the CMDh has agreed an update of the BPG on the processing of renewals in MRP and DCP.
- The previous approach for generic marketing authorisations with submission of a cover letter and eAF without annexes and a shorter timetable (30 days) will become the standard renewal procedure from now on for all marketing authorisations, regardless of the legal basis.
- As previously, it is possible for the Member States to request additional documentation, for national legislative reasons.
- An expanded procedure with an extended timetable (90 days) and full documentation will be applied only in exceptional cases, due to circumstances surrounding the individual marketing authorisation.
- The new process will be applicable to all MRP/DCP renewal applications submitted as of the publication of the revised BPG. This means that it is now applicable as it has been published.
- Ongoing procedures at the time of publication will be finalised according to the previous version of the BPG.
- For applications submitted before, but not yet started at the time of publication, it will be at the discretion of the RMS to decide whether to apply the new or the old process.
- The updated BPG will be published on the CMDh website under “Procedural Guidance > Renewal”
- The CMDh also agreed a corresponding update of the cover letter template for renewals. The updated template has been be published under “Templates > Renewals. Here you can view the track changed (December 2022) and clean (February 2023) versions of the document.
The Q&As on renewals will be revised once more experience with the new process has been
gained.
2. Position paper common grounds seen for invalidation/ delaying day 0 for variations
- The CMDh has agreed an update of its position paper on common grounds seen for invalidation/ delaying day 0 for variations.
- The document has been updated with the experience gained.
- Reference to the requirement to provide a dispatch list has been removed and the document has been aligned with the latest updates of the electronic application form (eAF) for variations.
- The updated document has been published on the CMDh website under “Procedural Guidance >Variation”. Here you can view the track changed (December 2010) and clean (February 2023) versions of the document.
3. Template for cover letter for renewals
Alongside the BPG on the processing of renewals in MRP and DCP, the CMDh also discussed
an update of the template for cover letters for renewals, aligning it with the new process. The
updated template was agreed and has been published on the CMDh website. You can download it here.
4. Best Practice Guide on fast-track procedure for the annual update of human
influenza vaccines
- DE presented an update of the BPG on fast-track procedure for the annual update of human influenza vaccines.
- Reference to the list of dispatch dates has been removed in line with other CMDh guidance documents
- An update of Annex III, which provides guidance on labelling particulars (strain descriptions) and which is in line with the requirements of Annex II to Guideline on influenza vaccines – submission and procedural requirements (EMA/56793/2014), is also foreseen
- Before the finalisation of the update of Annex III, the parallel update of Annex II of the EMA guidance will be awaited
- MSs were asked to provide comments on the update until 3 March 2023 for further discussion in the CMDh in March
5. Use of colourants (azo dyes) in paediatric medicines
- Based on a current example, where a CMS has raised PSRPH during a MAA procedure due to the presence of azo dyes in the formulation of the product (indicated in the paediatric population), the CMDh discussed if a reformulation of the medicinal product should be asked for if it contains azo dyes and is indicated for children or if the paediatric indication should not be approved.
- Reference was made to the CMDh discussions in 2017 and 2018, where, among others, the EC has been contacted.
- It was noted that several products with the same active substance are on the market without azo dyes. However, some have also been approved containing azo dyes.
- The EMA informed the CMDh that due to the EMA BCP the discussion on azo dyes in the excipients drafting group has been put on hold.
- It was acknowledged that the use of azo dyes in medicinal products (especially if indicated in the paediatric population) is discouraged and alternative solutions should be found, whenever possible. In any case, the use of azo dyes has to be thoroughly justified by the applicant.
- The CMDh agreed to send a question to CHMP to form a multidisciplinary group (including NcWP and clinical experts) to address the issue, assess the available data and to provide harmonised guidance, including a possible update of the excipients guideline, as needed. A question will be prepared by SK, CZ and EMA . The EC can be contacted again, as needed, once the feedback from CHMP is available.
- In the ongoing procedure, the discussion between RMS, CMS and applicant will continue in order to find a solution within the procedural timelines.
6. Need for PIP (waiver) for Art. 10c applications
- The CMDh discussed the PIP requirements for Directive 2001/83/EC Art. 10c applications based on a recent validation issue.
- Reference was made to the CMDh Q&As on the Paediatric Regulation (Q23) and the EMA Q&As on paediatric investigation plan (Q2.5).
- The CMDh agreed to follow the EMA position that MAAs under Art. 10c are in principle not excluded from the scope of the Paediatric Regulation.
- However, provided that both the applicant of the Art. 10c application and the MAH of the authorised product can be considered to have concerted practices (and the products to be part of the same GMA), the PIP/waiver decision of the authorised product can therefore also be referred to in the Art. 10c application.
Updates
| Date | Update(s) |
|---|---|
| 4 Apr 2023 | 1) Heading Report from the CMDh meeting held on 21-22 February 2023 updated to Report and minutes from the CMDh meeting held on 21-22 February 2023. 2) Link added to the minutes from the meeting. 3) Content under Point no 1updated to include the last sentence. 4) Points no 4, 5 and 6 added. |
| 12 Mar 2023 | Information added on the Q&A about the raw data proof-of concept pilot for industry. |
| 10 Mar 2023 | 1) Heading Product Management Services (PMS) Webinar on data migration and relevant content added. 2) Heading Guideline on computerised systems and electronic data in clinical trials plus relevant content added. |