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):
The European Health Data Space (EHDS) has advanced significantly since the initial concept of a digital transformation in healthcare across all EU member states.
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
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
30th January 2023 – the submission must be completed through CTIS
CT ends before
30th January 2025 – CT is maintained in EudraCT or national
systems
CT is expected
to continue after 30th January 2025 – transition from the EudraCT or
national systems to the CTIS is necessary.
CTIS podporuje interakce mezi sponzory klinických studií (výzkumníky nebo společnostmi, které provádějí klinickou studii a shromažďují a analyzují data) a regulačními orgány v členských státech EU...
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:
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...
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant sanofi-aventis, s.r.o., against the decision of the State Institute for Drug Control from 23. 3. 2021, under the no. SUKLS172396/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant sanofi-aventis, s.r.o. - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 9. 4. 2021, under the no. SUKLS182256/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Egis Pharmaceuticals PLC - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 12. 4. 2021, under the no. SUKLS182359/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Egis Pharmaceuticals PLC - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Union of Health Insurance Companies, against the decision of the State Institute for Drug Control from 10. 8. 2022, under the no. SUKLS85858/2022:
the decision under
appeal is reversed and the issue is referred back to the State Institute for
Drug Control for reappraisal.
A decision of the Ministry of Health regarding the appeal of the appelant Union of Health Insurance Companies - the decision is reversed and the issue is referred back for reappraisal.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 15. 3. 2021, under the no. SUKLS246602/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V. - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Ipsen Pharma S.A.S., against the decision of the State Institute for Drug Control from 12. 3. 2021, under the no. SUKLS306733/2020:
the decision under
appeal is reversed and the issue is referred back to the State Institute for
Drug Control for reappraisal.
A decision of the Ministry of Health regarding the appeal of the appelant Ipsen Pharma S.A.S. - the decision is reversed and the issue is referred back for reappraisal.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Union of Health Insurance Companies, against the decision of the State Institute for Drug Control from 29. 3. 2021, under the no. SUKLS265370/2018:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Union of Health Insurance Companies - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Union of Health Insurance Companies, against the decision of the State Institute for Drug Control from 18. 8. 2020, under the no. SUKLS48287/2022:
the decision under
appeal is reversed and the issue is referred back to the State Institute for
Drug Control for reappraisal.
A decision of the Ministry of Health regarding the appeal of the appelant Union of Health Insurance Companies - the decision is reversed and the issue is referred back for reappraisal.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Union of Health Insurance Companies, against the decision of the State Institute for Drug Control from 17. 12. 2020, under the no. SUKLS225105/2020:
the decision under
appeal is reversed and the issue is referred back to the State Institute for
Drug Control for reappraisal.
A decision of the Ministry of Health regarding the appeal of the appelant Union of Health Insurance Companies - the decision is reversed and the issue is referred back for reappraisal.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelants Gedeon Richter Plc., against the decision of the State Institute for Drug Control from 2. 11. 2022, under the no.: SUKLS25072/2022:
the decision is reversed and the proceedings are terminated.
A decision of the Ministry of Health regarding the appeal of the appelants Gedeon Richter Plc. - the decision is reversed and the proceedings are terminated.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelants MEDOCHEMIE Ltd, Otsuka Pharmaceutical Netherlands B.V. and Neuraxpharm Bohemia s.r.o., against the decision of the State Institute for Drug Control from 12. 10. 2022, under the no. SUKLS215140/2022:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelants MEDOCHEMIE Ltd, Otsuka Pharmaceutical Netherlands B.V. and Neuraxpharm Bohemia s.r.o. - the appeal is dismissed and the...
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Union of Health Insurance Companies, against the decision of the State Institute for Drug Control from 16. 8. 2022, under the no. SUKLS67567/2022:
the decision under
appeal is reversed and the issue is referred back to the State Institute for
Drug Control for reappraisal.
A decision of the Ministry of Health regarding the appeal of the appelant Union of Health Insurance Companies - the decision is reversed and the issue is referred back for reappraisal.
