Clinical trials of medicinal products
Accelerated procedure for mononational clinical trials
Regulation (EU) No. 536/2014 ("Clinical Trials Regulation", CTR) sets binding deadlines for the approval of applications. These deadlines are implemented and monitored in the Clinical Trials Information System (CTIS).
However, these deadlines are designed for procedures in which several Member States are involved in order to enable a coordinated assessment. In the case of clinical trials conducted exclusively in Austria ("mononational trials"), the coordination deadlines between Member States can be waived.
This enables an accelerated authorisation procedure - an incentive to strengthen Austria as a location for clinical research.
Despite the accelerated procedure, these trials are regular clinical trials to which all possibilities of the CTR apply. Once the clinical trial has been authorised, further Member States may subsequently be added in accordance with the procedure laid down in Article 14.
The following procedural deadlines will therefore apply to mononational clinical trials in Austria from 22 April 2025:
Formal completeness/validation:
The Federal Office and the Ethics Committee are guided by the "Document considerations for validation" task ("Task") provided for in the CTIS (7 days). The validation is finalised immediately afterwards by the "Submit validation decision" task. If necessary, formal subsequent requests are sent instead ("Consolidate Considerations/Submit RFI").
In the case of subsequent requests, the deadlines for response and final evaluation remain unchanged.
Content evaluation:
After completion of the validation, the Federal Office and the Ethics Committee are guided by the "Circulate Draft Assessment Report" task (26 days). Completion of the assessment ("Submit Part I/II conclusion") or the submission of additional requirements ("Consolidate Considerations/Submit RFI") takes place on the next working day.
The deadlines for response and evaluation also remain unchanged in the case of subsequent requests.
National decision:
The national decision is made immediately after Part I and Part II have been finalised.
Procedure step | CTIS Task | Deadline* |
Formal completeness/validation | Document considerations for validation Submit validation decision | 7 days (from receipt) |
Initial assessment | Circulate Draft Assessment Report | 26 days (after validation) |
Conclusion of procedure | Submit Part I conlusion Submit Part II Conclusion | 1 day |
National decision | Authorise | 1 day |
* These deadlines are exclusive of any extensions under Regulation (EEC) No. 1182/71. The deadlines used are always those specified by CTIS for the task.
The overall aim is to achieve a procedure duration of 35 days (procedure without deficiencies) or 60 days (procedure with deficiencies). These deadlines represent an official target within the framework of the CTR. Only the requirements of the CTR and the procedural decisions documented in the CTIS are legally binding.
BASG fee schedule for clinical studies
As of 01 January 2023 , an updated fee tariff of the BASG was put into force.
From this date, index-adjusted tariffs will apply for
- Clinical trials of medicinal products according to Regulation (EU) 536/2014
- Clinical trials of medicinal products according to Directive 2001/20/EC.
The reduction of tariffs for academic clinical trials of medicinal products was suspended in 2022!The same fees apply as for commercial studies.
Please refer to the BASG fee schedule for the current fees.
Withdrawal for technical reasons
If an application is rejected or withdrawn before the formal requirements have been examined, 10 per cent of the corresponding fee shall be paid in accordance with the BASG fee regulation. If an application is withdrawn after this time or if the application is refused, the entire fee must be paid.
For clinical trials pursuant to Regulation (EU) No. 536/2014 (CTR), the time of the finalised review of the formal requirements is the notification
- in accordance with Article 5(6) for initial applications
- in accordance with Article 17(5) for variations for Part I and Part I/II
- in accordance with Article 20(4) for variations for Part II
Technically, this corresponds to the completion of the "Submit Validation Decision" task in the Clinical Trials Information System (CTIS).
If a withdrawal is recommended by the EMA Helpdesk of the CTIS for technical reasons, this must be brought to the attention of the Federal Office by submitting the corresponding recommendation before the invoice is issued (conclusion of the procedure). Otherwise, a withdrawal on the part of the sponsor is assumed.
Information and training material
Information from the European Commission
The basis for clinical trials with medicinal products is the Regulation (EU) 536/2014 or Clinical Trials Regulation. This is published in the Official Journal of the Commission and is directly applicable in all member states of the Union and the EEA.
Regulation (EU) 536/2014 - Clinical Trials Regulation (CTR)
Eudralex Vol.10 contains important guidances and recommendations as well as template documents prepared by the Commission's working groups. They complement the legal basis of the regulation.
Eudralex Vol.10 - EU Commission Guidance on Clinical Trials
Information from the European Medicines Agency (EMA)
The European Medicines Agency (EMA) manages the central submission portal for clinical trials, the Clinical Trials Information System or CTIS. The EMA has published extensive guidance support documents as well as online training materials
General information on the CTR
