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.
The European Medicines Agency (EMA) has announced the launch of a new platform designed to routinely monitor shortages of centrally authorized medicines.
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.
The European Medicines Agency (EMA) has announced the launch of a new platform designed to routinely monitor shortages of centrally authorized medicines.
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...
