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.
The regulatory authorities in Romania, Moldova, Georgia, Ukraine and Bulgaria are highly supportive of clinical trials with exploratory/adaptive features, being experienced in approving modern protocol design approaches such as “integrated”/”umbrella”/”basket”/”platform” trials.
ARENSIA has the know-how to successfully manage the regulatory process in the above-mentioned countries. This is especially important for Phase I/II trials in patients which involve complex scientific/exploratory protocols and include compensation schemes for the patients.
In Romania and Bulgaria (EU countries) the regulatory approval process takes 60 days. Since 31st of January 2023, Romania and Bulgaria have implemented the new EU Regulation 536/2014. This implies that all initial submissions involving these 2 countries, like all EU countries, will be performed centralized as single on-line application into the Clinical Trial Information System (CTIS) having a reporting member state as lead reviewer.
In Moldova the regulatory approval process takes 30 days, parallel review by Health Authority and National Ethics Committee. Moldova is an EU-candidate country. The submission package is similar to the one in the EU countries. The main documents (such as IB, IMPD, Protocol, etc.) are submitted in English. The ICF language is Romanian, as it is the official language in Moldova, and also Russian.
In Georgia the regulatory approval process takes 30 days. Georgia is an EU-associated country. The submission package is similar to the one in the EU countries. The review by the Local Ethics Committee takes 10 business days, followed by the review of the Health Authority which takes 20 days. The study protocol and patient related documents are submitted in English language together with corresponding Georgian translation. The IB is submitted in English.
In Ukraine, the initial regulatory approval process takes 45 days. The submission of the documents is done in parallel to both the regulatory authority called 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 30 calendar days. The conclusion given by the SEC is approved by the Ministry of Health (up to 5 calendar days). The assessment of an application dossier submitted to the LEC, in validated format, takes 30 calendar days. The protocol synopsis and patient related documents are submitted in Ukrainian language. The 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
