Clinial trials with medicinal products
- Overview of initial applications, procedures and notifications from 2010 to 201906/05/2021
Since 31.01.2022, Austria is ready to accept clinical trial applications according to Regulation (EU) 536/2014 ("CTR") and also to act as Reporting Member State ("RMS").
Nevertheless, there was still preparatory work to be done nationally, which has been completed as of last week.
- The new Austrian Medicines Act (AMG) for the CTR framework was promulgated in the Federal Legal Information System (RIS) as of Feb. 14, 2022.
- In the following week, ethics committees seeking to operate under this federal law notified the Ministry of Social Affairs, Health, Care and Consumer Protection.
- The BMSGPK announced the future ethics committees under the CTR on its website.
- Last week, the future ethics committees under the CTR constituted themselves as "Platform Ethics Committees" according to §29 AMG, as amended, and adopted joint rules of procedure.
The Federal Office for Safety in Health Care and the platform have defined the details of their cooperation in an agreement according to § 30 AMG, as amended. This agreement will be published in the next few weeks.
On Monday 31st January 2022 at 9:00 a.m. CET, the Clinical Trials Information System (CTIS) has gone live. CTIS is the backbone of the Clinical Trials Regulation that will harmonise the assessment and supervision of clinical trials in the EU and the EEA.
To access CTIS, sponsors of clinical trials can visit the public Clinical Trials website at euclinicaltrials.eu. The login link for the secure workspaces is at the top right of this website. The “CTIS for sponsors” page provides key information and links for users. Users can read the User Access Management Quick guide for information on getting started with CTIS. Users are encouraged to review the CTIS online modular training programme for information on how to use CTIS.
The Clinical Trials Regulation and CTIS represent one of the most ambitious regulatory projects of the European medicines regulatory network. The development of CTIS involved the joint effort and dedication of Member State national competent authorities and ethics committees, clinical trial sponsors representing commercial enterprises (including SMEs) and academia, representatives of patients and healthcare professionals and members of the general public, EMA staff and contractors, the European Commission and HMA. The Clinical Trials Regulation and CTIS will strengthen clinical trials in the EU, ensuring better outcomes for patients and supporting the attractiveness of the European Union as a location for clinical research.
As of 28.01.2022 a new fee tariff of the BASG was put into force.
From this date, new or index-adjusted tariffs will apply for
- Clinical trials of medicinal products according to Directive 2001/20/EC
- Clinical trials of medicinal products according to Regulation (EU) 536/2014.
The tariffs for academic clinical trials of medicinal products are thus no longer reduced! The same fees for initial and amendment applications apply as for commercial studies.
Please refer to the BASG fee schedule for the current fees.
Before initiation of any clinical trial an application for approval needs to be submitted to the BASG. You will find a list of the documents necessary for proper submission in the document "List of documents required".
For detailed information on
- Submission of the clinical trial
- Assessment and approval procedure
- Obligations during the clinical trial and
- Obligations after completion of the clinical trial
please refer to the document "Guidelines for the submission of clinical trials according to AMG".
In addition, the general requirements for application of clinical trials with medicinal products of the European Commission (CT-1 Guidance Document, Euralex Vol.10) apply.
The application for approval of the clinical trial needs to be submitted to the responsible (lead) ethics committee before or at the same time as the application to the BASG. Information on the Ethics Commissions in Austria can be found at the Forum of the Austrian Ethics Commissions.
If a clinical trial is to be amended after approval, an amendment may be necessary. The document "Classification of Amendments" describes which changes are subject to approval or reporting by the authority or the Ethics Committee.
Further information on pharmacovigilance in clinical trials (SUSAR and DSUR) can be found here.
The current fees for clinical trials can be found in the BASG ordinance on fees.
The EU/EEA harmonised forms for
- the application for approval of a clinical trial (Annex 1)
- the application for approval of a substantial amendment (Annex 2)
- the notification of the national or global end of the clinical trial (Annex 3)
can be found in the "Eudralex Volume10: Clinical trials guidelines".
Please note that the application form must be created via the EudraCT database. The preparation of the form does NOT constitute a notification to the authority or ethics committee.
Initial applications, amendments and end-of-trial notifications should be submitted electronically via email@example.com.