REGULATORY PROCESS | CLINICAL TRIALS IN EASTERN EUROPE
Regulatory process in Romania, Bulgaria, Republic of Moldova, Georgia and Ukraine.
ARENSIA has the know-how to successfully manage the regulatory process in Romania, Bulgaria. Moldova, Georgia and Ukraine.
This is especially important for Phase I/II trials in patients which involve complex scientific/exploratory protocols and which – case by case – imply compensation schemes for the subjects.
Regulatory authorities in these countries are supportive of adaptive trial designs (integrated/basket/platform) which allow to modify doses, treatment regimens, in order to receive first efficacy results as early as possible.
In Romania and Bulgaria (EU countries) the regulatory approval process takes 60 days with parallel review by Health Authority and Central Ethics Committee. The set of documents required for submission in Romania is similar to the other countries in the European Union. All documents, except protocol synopsis and patient related documents (which are in Romanian, respectively Bulgarian language), are submitted in English.
In Moldova the regulatory approval process takes 30 days, parallel review by Health Authority and Central Ethics Committee. Moldova is an EU-candidate country. The submission package for clinical trials in Moldova is similar to the one in the EU countries (CTA Form not required). The main documents (such as IB, Protocol, etc.) are submitted in English. The documents facing the patients are in Romanian language (which is official language in Moldova).
In Georgia the regulatory approval process takes 60 working days. Georgia is an EU-associated country. The submission package for clinical trials in Georgia is similar to the one in the EU countries (CTA Form not required, IMPD not required, sample CRF translated in Georgian language required). The review by the local EC takes 14 days, followed by review from Health Authority (Drug Agency), which takes further 45 working days. Study protocol and patient related documents are submitted in Georgian language. IB is submitted in English.
In Ukraine the regulatory approval process takes 60 calendar days. The submission of the study documents is done in parallel to both the regulatory authority, State Expert Center (SEC) and to the Local Ethics Committee body (LEC). Ukraine is an EU-candidate country (CTA Form equivalent and IMPD required for submission). The expert evaluation of an application dossier submitted to the SEC, in validated format, takes 50 calendar days. The conclusion given by SEC is approved by the Ministry of Health (up to 10 calendar days). The assessment of an application dossier submitted to LEC, in validated format, takes 30 calendar days. Study protocol synopsis and patient related documents are submitted in Ukrainian language. IB is submitted in English.
We are glad to offer detailed information as guidance through the process and the set of documents required for submission of study dossier in each of these countries. Please contact us at info@arensia-em.com
Useful links:
- Romania: National Agency for Medicines and Medical Devices
- EMA: Guideline on strategies to identify and mitigate risks for first in human and early clinical trials with investigational medicinal products
- Ukrainian Health Authority
- European Medicine Agency
- Food and Drug Administration
- World Health Organization
- Clinical Trials US
- The International Council for Harmonisation
- EU Directive 2001/20/EC
