What are the documents required for clinical trial applications to regulatory authorities in Europe?
The key documents for a clinical trial application to regulatory authorities in the EU are: the cover letter, the application form, the study protocol, the IB/SmPC, the manufacturer/importer authorizations, the Qualified Person Declaration, the IMPD, the drug labels, and the evaluation fees (payment receipts).
What is Regulation EU No 536 2014?
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16th April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC [1], establishes a new set of harmonised rules that all member states are required to apply in all clinical trials performed throughout …
What is EU CTR regulation?
he European Union Clinical Trial Regulation 536/2014 (EU-CTR) aims to standardize and harmonize the conduct and management of interventional clinical trials across the European Economic Area (EEA), with legally binding rules on requirements and increased transparency.
Who regulates clinical trials in EU?
In 2001, the European Parliament and Council issued Clinical Trials Directive 2001/20/EC, which applies to member states of the European Union (EU) and regulates clinical trials throughout the EU.
How do I submit to DSUR?
You must submit your DSUR using MHRA Submissions via the Human Medicines Tile.
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The DSUR should include:
- a cover letter listing all the IRAS IDs and/or EudraCT numbers of trials covered by the DSUR .
- an analysis of the subjects’ safety in the concerned clinical trial(s) with an appraisal of its ongoing risk/benefit.
What is the EMA in clinical trials?
On January 31, 2022, the European Medicines Agency (EMA) launched a new clinical trials website that is underpinned by the Clinical Trials Information System (CTIS).
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When did EU clinical trials regulations take effect?
31 January 2022
European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022.
What is CTIS in clinical trials?
The Clinical Trials Information System (CTIS) supports the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission. CTIS went live with a searchable public website on 31 January 2022.
What is new in EU CTR?
EU-CTR leverages a new portal and database called the Clinical Trial Information System (CTIS) and enables a centralised, single electronic submission instead of multiple submissions with different dossiers.
How long is the EU CTR transition period?
three-year
The CTR foresees a three-year transition period. Member States will work in CTIS immediately after the system has gone live.
What is being replaced by the EU clinical trials regulation?
The Clinical Trial Regulation: boosting efficiency
The regulation will replace the existing Clinical Trials Directive 2001/20/EC and will harmonise the registration, assessment and supervision processes for clinical trials throughout the EU via the CTIS.
When should a DSUR be submitted?
The DSUR should be submitted to all concerned regulatory agencies no later than 60 calendar days after the DSUR data lock point.
Is DSUR same as annual report?
Generally, the contents of a DSUR and annual report are fairly similar (as outlined above). However, the DSUR tends to be a little more detailed in its data analysis and has a slightly stronger focus on potential impacts on patients.
What is CTIS EU?
What is EC in clinical trials?
All clinical research needs approval from an Ethics Committee (EC).
How do you find the EudraCT number?
The e-mail containing the EudraCT number should be printed and filed. As the trial progresses, the EudraCT number will be the main identifier for that trial and should be included on all correspondence (for example when reporting substantial amendments and safety reports).
What is difference between PSUR and DSUR?
The Development Safety Update Report (DSUR) is used for drugs still under development to assess risk to the subjects enrolled in the study, while the Periodic Safety Update Report (PSUR) is used for drugs already on the market to assess long-term safety.
What is the difference between PSUR and DSUR?
How often is DSUR submitted?
DSURs must be submitted at yearly intervals from the date of the CTA approval. For trials with marketed products, the date is the first marketing authorisation granted in the EU.
What is a clinical trial EMA?
A study performed to investigate the safety or efficacy of a medicine. For human medicines, these studies are carried out in human volunteers.
What is the difference between IRB and EC?
What is the difference between an IRB and IEC? Clinical trials conducted in the European Union are held accountable by Independent Ethics Committees (IECs). In the United States, Institutional Review Boards (IRBs) have oversight and must abide by the United States Food and Drug Administration (FDA) regulations.
What are the 13 principles of ICH GCP?
Ethics.
Is EudraCT mandatory?
As of 21 July 2014, it will become mandatory for sponsors to post clinical trial results in the European Clinical trials Database (EudraCT), managed by the European Medicines Agency (EMA).
What kinds of trials require a EudraCT number?
The EudraCT Number is a legal requirement for trials within the Clinical Trial Regulations scope. This station is part of the ‘trial planning phase’ group of stations. All Clinical Trials of Investigational Medicinal Products (CTIMPs) that have sites in the EU must be registered on the EudraCT database.
What is EU PSUR?
PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation.