Last updated: 27 April 2024
See updates at the end of the post.
Paediatric submissions on IRIS platform imminent
Please note that from 4 June 2024, the the following types of paediatric submissions must be done via IRIS.
- Initial paediatric investigation plan (PIP)
- Modification of an agreed PIP
- Product-specific waiver
- Compliance check
- Annual report on paediatric deferred measures
- Confirmation of applicability of a class waiver, or inclusion of an indication within a condition
- Discontinuation of paediatric development.
To ensure a smooth transition to using the IRIS platform, it is essential that applicants prepare well in advance, including registering for IRIS, as described in the following document:
For more information please see the announcement.
Sources: eSubmissions; EMA
General guidance: Anonymisation of personal data and assessment of commercially confidential information during the preparation and redaction of risk management plans (body and Annexes 4 and 6)
Revision 2 of this guidance has now been published. You can view it here.
Source: EMA
Simultaneous National Scientific Advice
On 19 April, the EMA held a webinar entitled Simultaneous National Scientific Advice – information and training webinar. You can view the webinar here. Information was provided under the following headings:
Welcome and opening remarks – 0:00– 6:52
Overview of the SNSA concept –6:53–11:00
Update on SNSA pilots to date 11:01–31:54
SNSA procedural outline including recent changes –31:55 – 1:01:45
Planned next steps for SNSA – 1:01:46 – 1:31:40
Q&A and Discussion –1:31:41 – 2:16: 59
Closing remarks – 2:17:00– 2:17:56
You can read more about SNSA in the following posts:
EU Simultaneous National Scientific Advice update (Aug 2021)
EU launches Phase 2 of the Simultaneous National Scientific Advice (SNSA) pilot (Nov 2022)
Source: EMA
New recommendations to strengthen supply chains of critical medicines
EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines included in the Union list of critical medicines and strengthen their supply chain.
These recommendations have been developed by EMA’s Medicines Shortages Steering Group (MSSG) and will facilitate the availability and supply of critical human medicines for which vulnerabilities in the supply chain have been identified.
Measures considered by the MSSG will be selected according to the risks posed to the supply chain and the type of medicine, and include:
- Possible recommendations to marketing authorisation holders (MAHs) to increase manufacturing capacity and diversify the suppliers in the supply chain (e.g. through the addition of alternative manufacturing sites), and to monitor forecasts of supply and demand of medicines and available stocks in the entire supply chain.
- Recommendations to certain actors in the supply chain, such as MAHs, and the European Commission to stockpile medicines to protect against fluctuations in demand or supply.
- The possibility to request a MAH to establish a shortage prevention plan for medicines in the Union list of critical medicines. EMA will publish guidance and templates for shortage prevention plans in June 2024.
- Provision of scientific and regulatory support to address vulnerabilities in the supply chain, including assistance to small and medium-sized enterprises.
Source: EMA
Meeting of a subgroup of CMDh with Interested Parties dedicated to (List of Safety Concerns (LoSC) and publication of PI updates – 22 February 2024
Presentations
1. Publication of LoSC
2. Publication of safety variations
Regulatory information – Updated fees for applications to EMA from 1 April 2024
The EMA reminds applicants and marketing authorisation holders that updated fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2024.
- Every year, the Commission adopts a regulation updating the fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2023 inflation rate was 3.4%.
- EMA published full details of the revised fees following the adoption of the Commission Regulation (EU) 2024/848 of 14 March 2024 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2024.
- Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 will not be revised in 2024 due to the implementation of Regulation (EU) 568/2024 coming into effect on 1 January 2025.
Updates
| Date | Update(s) |
|---|---|
| 27 Apr 2024 | 1) Added new section, General guidance: Anonymisation of personal data and assessment of commercially confidential information during the preparation and redaction of risk management plans (body and Annexes 4 and 6) 2) added new section, Paediatric submissions on IRIS platform imminent |
| 26 Apr 2024 | Added new section Simultaneous National Scientific Advice. |
| 23 Apr 2024 | New section on New recommendations to strengthen supply chains of critical medicines added. |
| 4 Apr 2024 | New section Meeting of a subgroup of CMDh with Interested Parties dedicated to (List of Safety Concerns (LoSC) and publication of PI updates – 22 February 2024 added. |