Lost updated: 14 November 2023
See updates at the end of this post.
List of safety concerns per approved Risk Management Plan (RMP) of active substances per product
This list has been updated and you can download the latest version of October 2023 here.
Report and minutes from the CMDh meeting held on 10-11 October 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. Call for review for chemically synthesised and biological medicinal products regarding nitrosamine impurities
The CMDh in liaison with EMA and CHMP has agreed an update of the Questions and Answers for MAHs/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products.
- Question 3 has been updated to provide information on the future of the call for review of nitrosamines in human medicines. You can view the updated Q&A document (October 2023) here.
- A statement has also been included in the CMDh and EMA websites that the deadlines of the call for review – including steps 1, 2 and 3 – for medicines containing chemically synthesised and biological active substances have passed.
Any marketing authorisation holder for such products that has not yet notified the relevant national competent authority about any nitrosamine impurities they have identified should do so as a matter of priority, in line with the CHMP’s Article 5(3) opinion.
Marketing authorisation holders should also update any previous notifications if needed, using the response templates and reporting mechanisms previously established.
EMA, together with the national competent authorities, is reminding marketing authorisation holders of their responsibility for ensuring the quality, safety and efficacy of their medicines. They also need to adhere to the nitrosamines guidance outlined by the European medicines regulatory network.
Marketing authorisation holders and manufacturers should work together and take precautionary measures to mitigate the risk of presence of nitrosamines during the manufacturing and storage of all authorised medicines.
Authorities in the EU will continue to take all necessary measures.
2. Recommendations on submission dates for applicants of the DCP and MRP
The CMDh has adopted updated guidance documents with the timetables for MRP/DCP applications to be submitted in 2024.
The updated guidance documents have now been published on the CMDh website under “Procedural guidance > Application for MA > MRP/DCP”. Links are provided below.
You can view the guidance Recommendations on submission dates for Applicants of the Decentralised Procedure (DCP) (October 2023) here.
You can view the guidance Recommendations on submission dates for Applicants of the Mutual Recognition Procedure (MRP) here.
3. CHMP Assessment Report Revamp Project
The EMA gave an update on the CHMP Assessment Report Revamp Project.
- As part of the project, applicants will be asked to pre-fill factual sections of the D80 AR.
- Response templates will be in a format to make it easy for assessors to directly use the responses.
- The project is being rolled out in steps with a pilot with industry starting in November 2023.
- The CMDh took note of the project with a view to possibly re-using some of the principles that are not yet included in DCP templates.
- The EMA will keep the CMDh informed of the progress.
Proposed Revision of QRD template for package leaflet (PL) improvement
This is a short presentation (approx. 11 mins) from the EMA on the above project which is started in June 2023 and will run until December 2024 when the revised template is expected to be implemented (with an implementation period). It is well worth watching.
Source: EMA
Revised transparency rules for the EU Clinical Trials Information System (CTIS)
Following feedback from an eight-week public consultation was held between May and June 2023. An eight-week public consultation was held between May and June 2023, the The EMA has adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS).
The simplifications introduced will give access to clinical trial information to stakeholders including patients and healthcare professionals in a faster and more efficient way.
The updated rules strike a balance between transparency of information and protection of commercially confidential information.
- They benefit patients, because key clinical trial information, that patients flagged as being most relevant for them, is published early.
- They also introduce process simplifications that benefit clinical trial sponsors who have to protect commercially confidential information and personal data.
- Finally, they benefit healthcare professionals because the resulting system is more user-friendly, facilitating access to information about clinical trials and enrolment in clinical trials, and also increasing awareness of possible treatment options.
One of the key changes of the revised rules is the removal of the deferral mechanism, which allowed sponsors to delay the publication of certain data and documents for up to seven years after the end of the trial to protect personal data and commercially confidential information (CCI).
Whilst the Agency will endeavour to finalise implementation of the revised transparency rules by the second quarter of 2024, the effective date of completion of the process and application of the new rules will be communicated to CTIS users in due course and prior to the date when they will become applicable.
Webinar on transparency rules for the EU Clinical Trials Information System CTIS held on 13 September 2023.
Source: EMA
CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product
This position paper has been updated. Here, you can view the track changed (Jan 2023 Rev 11) and clean (Oct 2023 Rev 12) versions of the document. It is not clear exactly what changes have been applied to the updated document.
Mobile scanning and other technologies, such as QR codes (abbreviated from Quick Response Codes) and other two-dimensional (2D) bar codes or Near-field Communication (NFC), amongst others, are used to provide easy access by patients and/or Health Care Professionals to information through a smartphone/device. Therefore, the information is available in additional ways than the approved written statutory presentation can and may reach a wider audience.
The possibility of using mobile scanning and other technologies as a way to provide information on medicinal products in a broad sense is currently being considered not only by the Pharmaceutical Companies but also the National Competent Authorities.
- This paper only addresses the use of mobile technologies to access a dedicated platform maintained by the Marketing Authorisation Holder (MAH) or national competent authority (NCA) with information about the medicinal products.
- It provides guidance in relation to the assessment of the content, independently of the technology used.
Considering the rapidly evolving innovations in the field of mobile technologies, this paper does not endeavour to include a comprehensive list of available technologies.
Source: CMDh
Qualification of novel methodologies for drug development: guidance to applicants
The above guideline was last revised on 5 October 2023. Essentially, the hyperlinks have been updated. You can view it here.
Source: EMA
Updates
| Date | Update(s) |
|---|---|
| 14 Nov 2023 | 1) The heading of the section Report from the CMDh meeting held on 10-11 October 2023 was amended to Report and minutes from the CMDh meeting held on 10-11 October 2023 an a link provided to the minutes from the meeting. 2) In point no 2 of the same section, links are now provided to the updated guidance documents. 3) Point no 3 was added to the section. |
| 20 Oct 2023 | Heading List of safety concerns per approved Risk Management Plan (RMP) of active substances per product added, plus relevant content. |
| 19 Oct 2023 | Heading Report from the CMDh meeting held on 10-11 October2023 plus relevant content added. |
| 13 Oct 2023 | 1) Heading Proposed Revision of QRD template for package leaflet (PL) improvement plus relevant content added. 2) Under the heading Revised transparency rules for the EU Clinical Trials Information System (CTIS), link added to EMA webinar of 13 September 2023. |
| 8 Oct 2023 | Heading Revised transparency rules for the EU Clinical Trials Information System (CTIS) plus relevant content added. |