Preliminary Announcement and Ethics Committee Review
Preliminary Announcement for Ruling on Jurisdiction for Clinical Trials on Medicinal Products
To begin the ethical evaluation of the study the sponsor needs to apply for a ruling from TUKIJA on whether the ethical admissibility of the proposal is to be reviewed by TUKIJA or by one of the five regional Ethics Committees (i.e. pre-notification of clinical trial on medicinal products). The answer for ruling are normally given within 14 days by TUKIJA and the final ethical decision within 60 days either by TUKIJA or regional Ethics Committee. The pre-notification to TUKIJA can be submitted as soon as it's been known that the trial in question will be run in Finland, even if the actual application is not yet complete. Depending on the ruling, the sponsor then applies for an ethics review to be carried out either by TUKIJA or by the relevant regional Ethics Committee. Applicants are also requested to submit their applications in electronic format (pdf or rtf) to TUKIJA's secretary by e-mail to tukija(at)valvira.fi. Deadlines for submitting applications for rulings on jurisdiction are given at TUKIJA’s web pages.
Applying for Ethics Reviews to be carried out by TUKIJA or by Regional Ethics Committees
After obtaining ruling on jurisdiction, opinion of the Ethics Committee can be applied. The form to be used, together with the intructions, is issued by the Ministry of Social Affairs and Health and it's available at TUKIJA’s web pages The documents listed on the form must be included in all applications (for further information please see here).The form is available in Finnish only.
Sponsors must have a Finnish speaking contact person
in EU area to facilitate communication during the application
procedure. TUKIJA and regional Ethics Committees keep a register of the
diary numbers for clinical trials on medicinal products. The same diary
number is used in further submissions of amendments or new documents,
meeting minutes, and in any subsequent correspondence related to the
trial. In the meeting minutes TUKIJA and regional Ethics
Committees inform the sponsor whether the proposal discussed was
approved, whether any additional information had to be requested, or
whether the proposal was rejected, as well as the fees to be collected.
The meetings and submission deadlines as well as the members of the
Ethics Committees are listed at regional Ethics Committees’ web pages.
Copies of opinions are also forwarded to the Clinical Drug Trials Unit
of the Finnish National Agency for Medicines, Fimea.