Last updated: 1 February 2024
See updates at the end of the post.
Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
Here, you can view the track changed (September 2023) and clean (January 2024) versions of the guidance with the above title.
The bulk of the changes concern the responses to Questions Nos 33 and 34.
Questions and answers to Stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use
On 5 January 2024, a document with the above title which provides practical guidance on the applicable rules to centrally authorised medicinal products (CAPs) for human use, intended to be placed on the market in Northern Ireland before and after the application of Regulation (EU) 2023/1182, was published. You can view it here.
The document contains information on:
- Scope and applicability of Regulation (EU) 2023/1182
- Authorisation and supervision of medicinal products eligible to the centralised procedure to be placed on the market in Northern Ireland
- Transitional provisions
- Multi-country packs for centrally authorised products between Northern Ireland / UK and an EU / EEA Member State
- Update of the product information for centrally authorised products
- Marketing status reporting
- Parallel distribution
- Issues related to marketing authorisations and their procedures
Note that Regulation (EU) 2023/1182 entered into force on 21 June 2023 and will become applicable from 1 January 2025.
Source: EMA
Products Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe – Chapter 7 updated
Version 3 (of 30 January 2024) of the document concerning Chapter 7 – Migration guide – migration rules between xEVMPD and PMS including backwards compatibility rules, is now available. You can view it here.
The EMA intends to migrate the Centrally Authorised Products (CAPs) and non-Centrally Authorised Products (non-CAPs) data held in the eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) and submitted by marketing authorisation holders (MAHs) under the Art.57 (2) legal obligations into the ISO IDMP-compliant data format and terminologies.
In addition to the data stored in XEVMPD, EMA intends to migrate the Centrally Authorised Products (CAPs) data held in its internal database called SIAMED II ultimately building the new ISO IDMP compatible repository [i.e. Product Management Services (PMS)] in PMS.
Chapter 7 provides information on the approach followed by the European Medicines Agency (EMA) to enable the transformation and migration of the data to the PMS. Specifically, this chapter aims at describing the following aspects:
• migration of CAP data into PMS;
• migration of non-CAP data into PMS;
• match and merge of CAP data from SIAMED II and XEVMPD;
• the Art.57 – SIAMED II – PMS data mapping;
• the transformation rules that will be applied to the data during the migration into PMS.
This chapter is purely for information and transparency, it does not require or oblige individual stakeholders to implement this approach in their in-house systems.
Information on any of the other chapter of substance and product data management services is available here.
Source: EMA
114th Heads of Medicines Agencies Meeting (HMA II) December 1st, 2023
You can view the minutes of the above meeting, here. It is pity that there is not much more available from this meeting beyond the minutes.
The following point was covered in the DG Sante update:
Revision of the variation framework for medicines is foreseen in the Commission work program 2023, independent from the revision of the pharma legislation. Amendments to be adopted in the first 1st half of 2024.
User guide for micro, small and medium-sized enterprises updated
The latest version of the above guide (Nov 2023) on the administrative and procedural aspects of the provisions laid down in Regulation (EC) No 726/2004 and Regulation (EU) 2019/6, that are of particular relevance to SMEs, has been published. This is a major update. You can view it here.
The guide:
- is structured to follow the chronological stages of developing a medicinal product. An overview of the scientific data requirements for obtaining a marketing authorisation in the European Union (‘EU’) is provided. The regulatory procedures in place to optimise development and obtain an EU marketing authorisation are also summarised.
- focuses primarily on the requirements for authorising medicinal products for human or veterinary use. It also includes a section on activities related to medical devices.
- is not intended to be an exhaustive document but rather to raise SMEs’ awareness of the various sources of information available, with links throughout the text to additional information.
You can read more about the changes to the guide here.
Human medicines: highlights of 2023
The overview of the 2023 key recommendations published on 16 January includes figures on the authorisation of medicines and a selection of new treatments that represent significant progress in their therapeutic areas.
In 2023, EMA recommended 77 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public health needs or the innovation they represent.
Source: EMA
A new version of the eSubmission Gateway XML delivery file for SEND packages now available
An updated version of the eSubmission Gateway XML delivery file user interface is available starting 11 January 2024, 18:00 CET.
This update introduced in the delivery file for Human submissions, the option to specify if there is a “SEND Data package Included”.
Updated release notes and user guidance are published in the relevant section.
Users should note that the delivery files created prior to the new release will not work after the go live.
Source: eSubmissions
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024
You can view the meeting highlights on this page and the meeting agenda here.
Source: EMA
Interactive Regulatory Information System (IRIS) guide to registration and Research Product Identifiers (RPIs)
Version 2.16 (of Jan 2024) of the above guide concerning preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration has been published. You can view it here.
Source: EMA
Opportunity to submit SEND data packages with new Market Authorisation Applications
From January 2024, EMA has launched launching a proof-of-concept study to evaluate the added value of using SEND data in the evaluation of new Marketing Authorisation Applications.
- Applicants are encouraged to submit their SEND data packages, in addition to the eCDT format, as part of their MAA submission.
- The SEND package must be provided outside the eCTD, inside the working documents folder to avoid eCTD technical validation failure.
- An updated version of the eSubmission Gateway XML delivery file user interface will be available starting with 11 January 2024, 18:00 CET.
- This update introduces in the delivery file for Human submissions the option to specify if there is a “SEND Data package Included”.
- Users should note that the delivery files created prior to the new release will not work after the go live.
What is SEND?
SEND is the Standard for Exchange of Nonclinical Data between organisations, which provides a standardised format for the submission of nonclinical data to regulatory bodies.
SEND was created by the Clinical Data Interchange Standards Consortium (CDISC) in 2002 to execute on the Study Data Tabulation Model (SDTM) for the submission of nonclinical studies. A SEND dataset package contains the SEND datasets (.xpt files), the Nonclinical Study Data Reviewer’s Guide (nsdrg.pdf), and the Define XML Document (define.xml).
Why a proof-of concept?
Standardisation of data presentation has been shown to significantly reduce the time regulators require for reviewing the non-clinical data packages. In this proof-of-concept study, we will evaluate whether using SEND data in the assessment of the non-clinical dossier will lead to improved and more consistent quality of assessments, to more science-driven questions to Applicants, and to faster completion of the non-clinical dossier assessment.
Source: eSubmissions
Updates
| Date | Update(s) |
|---|---|
| 1 Feb 2024 | Added section Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP |
| 31 Jan 2024 | 1. Added section entitled Questions and answers to Stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use 2. Added section Products Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe – Chapter 7 updated |
| 30 Jan 2024 | Added section 114th Heads of Medicines Agencies Meeting (HMA II) December 1st, 2023. |
| 26 Jan 2024 | Bullet points and a link added to the section User guide for micro, small and medium-sized enterprises updated |
| 23 Jan 2024 | Added section User guide for micro, small and medium-sized enterprises updated |