General information.
Clinical studies is a very new but fast-growing business in Ukraine. Quantity of clinical trials submitted to MOH grows approximately 200% per every one year. There are many different reasons for such extremely fast development:
- there are almost 50 millions of inhabitants in Ukraine;
- Ukraine is situated very close to Europe (neighbor to Poland);
- our local legislation in clinical studies is almost copied from European;
- there are no insurance medicine in Ukraine (less than 3% of inhabitants use insurance medicine);
- average income for one person is more than 5 times lower than in Europe;
- donations from state budget to medicinal infrastructure is very low, salaries of doctors are almost the lowest in whole economy;
- many different private laboratories and analysis centers with excellent modern equipment are present;
Legislation.
Legislation in the field of clinical studies is changing almost every year towards European and US standards. Currently legislation is very close to European, though there are always some specific particularities due to the local situation and customs.
Currently the following lists of normative acts are in force :
- Law on medicine, articles 7, 8 & 12 (document is available in English)
- Order of MOH #281 as of November 01, 2000 “Instruction for clinical studies and Bio-Ethic committee” (download in Ukrainian language).
- Order of MOH #355 as of September 25, 2002 “About changes to Order #281” (download in Ukrainian language).
- Order of MOH #420 as of October 22, 2001 “List of sites, medicinal institutions and clinics where clinical studies can be evaluated” (download in Ukrainian language).
- Order of MOH #347 as of December 26, 2000 "On Approval of Instructions for surveillance
over adverse reactions/effects of
medicinal products" (document is available in English).
- Order of MOH #396 as of August 26, 2003 “Additional list to the Order #420” (download in Ukrainian language).
- Order of MOH #373 as of July 22, 2005 “About certification, standardization, registration, approval and carrying out of clinical studies in Ukraine” (download in Ukrainian language).
Approval (registration) of clinical studies in Ukraine.
To start clinical studies it is needed to receive an approval from local MOH. Department of MOH that is responsible for adoption of clinical studies is the State Pharmacological Center (SPC) of Ukraine (sub-department on clinical trials and investigations). To initiate the procedure Application & Dossier should be submitted. It usually takes 3-9 months to receive an approval.
Our offer.
Bureau “Cratia” can offer to you a full or partial solution of clinical studies in Ukraine.
Full solution (from A to Z):
- Clinical studies phases I-IV.
- Bioequivalence studies.
- Bioavailability studies.
Partial solutions:
- Assistance in adoption of the clinical studies in Ukraine: preparation of the protocol and other parts of the dossier or translation of your documents to Ukrainian, submission of the Application & dossier to the State Pharmacological center, accompanying of the dossier it during expertise procedure by SPC and Bio Ethic Committee (BEC) up to the receipt of the Approval;
- Negotiations with appropriate bases to carry out clinical studies;
- Recruitment of volunteers;
- Insurance of volunteers;
- Import, storage and delivery of the study medication & devices (blood containers etc.) to sites and from sites to laboratory.
- Local laboratories to perform tests;
- Control and results reporting;
We can evaluate studies phases I-IV, participate in multibase studies or perform only the required part (stage) of study.
Since every study has many different particularities, our offer can be provided only upon your request. |
