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The European Medicines Agency (EMA) has announced the launch of a new platform designed to routinely monitor shortages of centrally authorized medicines. This platform is a direct result of Regulation (EU) 2022/123, which aims to improve preparedness for and mitigation of medicine shortages across EU member states.

Key Points:

• Platform Availability: The European Shortages Monitoring Platform (ESMP) is now accessible online.
• Mandatory Usage: Starting from February 2, 2025, all Marketing Authorization Holders (MAHs) with centrally authorized products will be required to use the ESMP.
• Early Familiarity: EMA encourages MAHs to familiarize themselves with the platform before the mandatory deadline.
• Data Submission: Until February 2, 2025, MAHs and National Competent Authorities (NCAs) can submit data on supply, demand, and availability of both centrally and nationally authorized medicines to the EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).
• Medicine Monitoring: The platform will be used for routine monitoring of all centrally authorized medicines and may also be used for monitoring nationally authorized medicines under special circumstances.

Additional Resources:

• Frequently Asked Questions

The European Health Data Space should lead to the empowerment of citizens and support for research and innovation.

EU residents will have more control over their health data, being able to access it electronically and share it across borders. This is particularly beneficial for cross-border healthcare, allowing individuals to access medical records and receive care seamlessly throughout the EU.

The EHDS promotes the secondary use of health data for research, innovation, and policy-making. Researchers and innovators will be able to access health data more easily and securely, which could drive the development of new treatments, medical devices, and AI applications.

The main objectives of the European Health Data Space (source: excerpt from the Communication from the Commission to the European Parliament and the Council: The European Health Data Space: Harnessing the power of health data for people, patients, and innovation):  

EHDS - main points:

• 3 May 2022 – European Commission launched the EHDS regulation proposal to easier exchange and access health data at EU level.
• 6 December 2023 – The EU Council approved the regulation proposal.
• 15 March 2024 – After five tripartite meetings between Parliament, the Council and the Commission, so called “trialogue”, an agreement on provisional proposal was reached between the European Parliament and the EU Council. The compromised text contains e.g. a right to opt-out of the system, an electronic health records system assessment, a data localisation and some specific timelines of implementation.
• 24 April 2024 - The European Parliament formally approved EHDS regulation proposal. After the end of the legislative process, the European Parliament and the Council will adopt the final text of the new Regulation. 
• The proposal is currently in its first reading procedure, document identifier COM(2022)0197. The European Parliament is expected to decide on the proposed amendments by the end of December 2024. 

EHDS general information:

One key feature of the EHDS is the introduction of common standards for electronic health record (EHR) systems across the EU, fostering interoperability and creating a single market for these systems. This includes a mandatory self-assessment for systems to ensure secure data storage and transfer.

The regulation also establishes an opt-out system where individuals can choose to restrict access to their data for secondary purposes, such as research, while still allowing essential data sharing for healthcare delivery. Member States will manage access requests for health data and may implement stricter rules for sensitive information like genetic data.

The EHDS framework is expected to enhance patient care by reducing unnecessary testing and improving evidence-based decision-making. It also strengthens privacy protections while enabling the reuse of health data for public health and research purposes.

CTIS byl zřízen farmaceutickým zákonem v rámci Nařízení o klinických studiích (Nařízení (EU) č. 536/2014) a po 30. lednu 2025 kompletně nahradí původní systém pro klinické studie EudraCT (Databáze klinických studií orgánů pro regulaci léčiv Evropské unie).

Evropská léková agentura (EMA) průběžně publikuje zprávy, jak proces přechodu na nový systém pokračuje.

V předchozím článku jsme ukazovali, jaká byla situace v únoru 2024, v tomto článku jsme informace o počtu podání a rozhodnutí o přechodu aktualizovali ke konci srpna 2024.

Obr. č. 1 – Změny v počtu podaných žádostí, resp. v počtu podání, kde již bylo rozhodnuto, v porovnání s předchozím měsícem

V průběhu léta aktivita podávání žádostí poklesla, ale ve srovnání se stavem v únoru je celkový počet podaných žádostí vice než dvojnásobný a počet studií s rozhodnutím je také skoro dvojnásobný.

Nicméně stále jsou klinické studie, pro které je třeba podat žádost.

EMA publikuje novinky v této oblasti každé dva týdny, kde mj. uvádí, jaké změny v systému CTIS provedla.

Také připravila Information Day for CTIS 17. října 2024 pro všechny zainteresované subjekty.

Uložte si datum do kalendáře a nepolevujte v přechodu vašich studií na nový systém.

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Důležité milníky pro klinické studie:

• Klinické studie zahájené po 30. lednu 2023 – všechny žádosti o počáteční klinické studie v Evropské unii (EU)/Evropském hospodářském prostoru (EHP) musí být podány prostřednictvím CTIS
• Klinické studie ukončené před 30. lednem 2025 – Klinická studie je spravována v systému EudraCT nebo národních systémech
• Klinické studie, u kterých se očekává, že budou pokračovat po 30. lednu 2025 – je nutný přechod z EudraCT nebo národních systémů na CTIS.

Obr. č. 2 – schéma přechodu na nový informační systém pro klinická hodnocení

CTIS was established by pharmaceutical law in the Clinical Trials Regulation (Regulation (EU) No 536/2014) and will completely replace the previous system for clinical trials EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) after 30th January 2025. CTIS supports interactions between clinical trial sponsors (researchers or companies that run a clinical trial and collect and analyse the data) and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.

CTIS is guaranteed by European Medicines agency (EMA) and works in a secured workspace.

The important milestones for clinical trials:

• CT starts after 30^th January 2023 – the submission must be completed through CTIS
• CT ends before 30^th January 2025 – CT is maintained in EudraCT or national systems
• CT is expected to continue after 30^th January 2025 – transition from the EudraCT or national systems to the CTIS is necessary.

Although the deadline is still 11 months away, according to the EMA's recommendations, the transition process should begin without delay. There are a few tricky points in the transition process that are worth noting.

• The transition should take 2 months (according to the EMA methodology) but be prepared for a longer period. Once the process is complete, all information and data are processed through CTIS.
• The new country should be included in clinical trial after the transition in all current clinical trial countries is complete.
• The national language especially with special characters, can be a problem. You must provide labels in the national language.
• Relation in workspace can be unstable, in which case the submission may not complete successfully and a resession may be required. 

Because the system is not intuitive and not easy to use (experience), there are guidance and Q&As from EMA (link) as well as webinars (link) for users and sponsors. 

EMA has also published an interesting video to improve awareness of the regulation of the clinical trials system: https://youtu.be/0nQ2ABHa9L0?feature=shared 

In the next video, EMA introduces CTIS workspaces and common system functionalities to users: https://youtu.be/NSQmVtqhmWo?feature=shared 

EMA publishes CTIS statistics weekly (link). Last published data from 6th to 12th February 2024:

Despite difficulties, until now there are 2473 successful submissions. However, there are also many CTs that must go through the transition either. 

If this is also the case with your CT, don't delay any longer and go for the submission. Good luck, you'll make it.

Based on the amendment to Act No. 235/2004 Coll., on Value Added Tax, as of January 1, 2024, there has been a change in VAT rates, particularly impacting the increase in prices and reimbursements for medicinal products. In the infographics, we will illustrate how the individual rates have changed and examine the international comparison to assess the impact on the Czech Republic.

While the standard VAT rate remains at 21 percent, the original reduced rates of 15 percent (for medical devices) and 10 percent (for medicinal products) have been unified into a single 12 percent rate. The newly introduced zero rate applies exclusively to books, although the inclusion of medicinal products could have been possible in line with European legislation.

The infographics provides an overview of the changes in rates as follows:

In international comparison, the Czech Republic finds itself in the less favorable top positions of the ranking of applied VAT rates on reimbursed medicinal products. Many countries still maintain lower, extra reduced, or even zero VAT rates on medicinal products despite the current economic situation.

Source: Statista. (2023, December 21). VAT rate on prescription-only drugs in Europe by country 2023. https://www.statista.com/statistics/458957/vat-rate-on-prescription-only-drugs-in-europe/