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Special features of clinical drug trials in the Republic of Armenia

Clinical drug trials in the Republic of Armenia are held to confirm their safety and effectiveness, as well as, to obtain information about possible side effects. Permission to hold clinical drug trials are issued by the Ministry of Health of the Republic of Armenia. Tests are carried out on pre-established Ministry of Health medical institutions. I would like to emphasize that these tests play an important role in the development of pharmaceuticals and medicine in general, however, in addition to the indisputable beneficial effect, clinical trials always carry a risk of harm to human life and health. For this reason, clinical drug trials should be transparent and be under the control of the appropriate organs of the State.

In order to conduct clinical trials in the Republic of Armenia, the Ministry of Health will expect an application with all necessary supporting documents. These documents must contain the following information:

  • The results of pre-clinical studies and/or trials of safety and effectiveness of medicines;
  • Compelling information about the positive result of the use of drugs, which exceeds the level of perceived threat;
  • The positive written opinion of the Ethics Council.

To obtain permission for clinical trials in the Republic of Armenia, the company conducting the proposed trials must conduct an expertise, divided into two stages:

  • Preliminary examination, which gives an explanation on the compliance of the documents with the established requirements in terms of their correctness and completeness;
  • Verification of the clinical development program with a view to its adoption, the period of which equals sixty days.

The Ministry may require the submission of additional documents and/or correction of already submitted documents. If within sixty days from application, the deficiencies in the existing documents are not corrected and additional documents are not presented, the materials will be removed from the examination.

Based on the results of examination the Ministry of Health will decide whether to permit clinical studies. The Ministry of Health will notify the company in writing within three days after completion of the examination.

The procedure for conducting clinical trials

The person and/or company conducting the trials must:

  • Immediately notify the Ministry of Health and the Board of Ethics of the changes made to the program of studies, as well as, of any unpredictable external influences and events that occurred during the trials;
  • Immediately stop the trial if there is a threat to life or health of the subject;
  • Ensure the confidentiality of data on the tests and the trial in general;
  • To record, process and store the information obtained through research, in a manner that makes it possible to monitor their accuracy and reliability.

A person who participates in a clinical trial must be informed by the doctor carrying out the trials about nature, meaning, methods and possible threats of the trials. Additionally that at any stage of the trial the subject can refuse further tests. Once this has been explained the subject then gives written consent to participate in research and clinical trials.

The clinical trials cannot involve:

  • Pregnant women, except in cases where the necessary data can only be obtained from a study of pregnant women, as long as the threat to the pregnant woman or the fetus is minimal;
  • Armed forces;
  • Persons serving time in prisons and/or detention centers.

The Ministry of Health and the Ethics Council will conduct check-ups, usually held once every three months. In case of violations in the ongoing research a protocol is drawn up. Any shortcomings identified in the check-up process must be removed within thirty days after the identification and the Ministry of Health notified.

When identifying gross violations of the approved program, the Ministry of Health of the Republic of Armenia does not approve the results of the clinical trial. The Ministry of Health makes an appropriate decision in case of gross violations and notifies the company in writing within three days of making the decision. In case of violation of ethics rules and/or program of clinical studies, the falsification of data, unexpected side effects, and other non-foreseen phenomena, as well as, the threat(s) to life or health of the subject(s), The Ministry of Health will immediately suspend all testing process.

Based on the results of clinical trials of medicines in the Republic of Armenia, the researcher and/or company conducting the trials must submit a report to the Ministry of Health based on the data collected. This report is subject to a specialized expertise within one month of receiving the clinical trial data. Should the Ministry of Health reach a positive conclusion, the Ministry approves it. As per above rules, the Ministry of Health will notify the company in writing within three days of reaching a conclusion.

The list of required documents that must be presented with the application to obtain permission to conduct clinical drug trials in RA:

  • The application addressed to the Minister of Health for permission to conduct clinical trials;
  • The program of clinical trials in the Armenian language. In case of translation into the Armenian language, the company must supply the original in Russian or English, or other languages;
  • The personal record card of experience, of the person or company conducting the trials;
  • The researched journal of entries that includes the collection of the results of a preclinical and clinical review of safety and effectiveness of the drug in the Armenian language. In case of translation into the Armenian language, the company must supply the original in Russian or English, or other languages;
  • Written agreements from each test subject agreeing to become test subjects in the trials in the Armenian language. In case of translation into the Armenian language, the company must supply the original in Russian or English, or other languages;
  • A written list of data and other information provided to prospective test subjects in the Armenian language. In case of translation into the Armenian language, the company must supply the original in Russian or English or other languages;
  • The original documents on education and official accreditation of the person(s) and/or company carrying out the proposed clinical drug trials in the Armenian language. In case of translation into the Armenian language, the company must supply the original in Russian or English, or other languages;
  • Copy of the contract between the customer and the researcher in the Armenian language. In case of translation into the Armenian language, the company must supply the original in Russian or English, or other languages;
  • Documents related to the life insurance for the test subjects in the Armenian language, if available. In case of translation into the Armenian language, the company must supply the original in Russian or English or other languages.

04.21.2016

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