of November 6, 2020 No. 94
About clinical trials (testing) of medicines
Based on parts two and the fifth article 17 of the Law of the Republic of Belarus of July 20, 2006 "About drug circulation" the Ministry of Health of the Republic of Belarus DECIDES: No. 161-Z
1. Approve:
The regulations on procedure and conditions of performing clinical trials (testing) of medicines (are applied);
The regulations on independent ethical committee (are applied).
2. Recognize invalid:
the resolution of the Ministry of Health of the Republic of Belarus of March 28, 2008 No. 55 "About approval of the Regulations on committee on ethics";
the resolution of the Ministry of Health of the Republic of Belarus of June 25, 2009 No. 72 "About entering of amendments and changes into the resolution of the Ministry of Health of the Republic of Belarus of March 28, 2008 No. 55";
the resolution of the Ministry of Health of the Republic of Belarus of April 17, 2015 No. 40 "About introduction of amendments to the resolution of the Ministry of Health of the Republic of Belarus of March 28, 2008 No. 55".
3. This resolution becomes effective after its official publication.
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Deputy minister |
B. N. Androsyuk |
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It is approved Ministry of Foreign Affairs of the Republic of Belarus |
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Approved by the Resolution of the Ministry of Health of the Republic of Belarus of November 6, 2020 No. 94
1. This Provision determines procedure and conditions of performing clinical trials (testing) of medicines (further if other is not established, - clinical trials) on subjects of research in the state organizations of health care (further if other is not established, - the organizations of health care).
2. In this Provision terms and their determinations in the values established by the Law of the Republic of Belarus "About drug circulation", the Rules of proper clinical practice of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 79 are used (further - Rules of proper clinical practice).
3. Conditions of performing clinical trials are:
decision of the Ministry of Health on purpose of clinical trial and issue of permission to performing clinical trial;
approval by the Ministry of Health of the program (protocol) of clinical trial approved by independent ethical committee under the organization of health care (further - ethical committee of the organization of health care);
compliance of qualification of researchers to requirements of Rules of proper clinical practice;
compliance of conditions for performing clinical trials in the organizations of health care to requirements of Rules of proper clinical practice.
4. Clinical trial is appointed by the decision of the Ministry of Health which is preceded:
complex of the preliminary technical works (further, if is not established other, – the complex of preliminary works) connected with conducting examinations, performed by the republican unitary enterprise "The Center of Examinations and Testing in Health Care" (further if other is not established, – the Center);
approval of performing clinical trial by independent ethical committee of the organization of health care based on which, (which) performing clinical trial is planned.
5. The complex of preliminary works is carried out based on the contract between the Center and the sponsor of clinical trial or the contractual research organization, competent to file documents for receipt of permission to performing clinical trial (further if other is not established, – the applicant).
Aggregate term of carrying out complex of preliminary works shall not exceed 120 calendar days. The specified term can be prolonged up to 360 calendar days by agreement of the parties.
6. For carrying out complex of preliminary works as the applicant it are represented to the Center:
the statement in any form with appendix of information to it for carrying out complex of the preliminary works preceding issue of permission to performing clinical trials on form according to appendix 1;
documents for carrying out complex of the preliminary works preceding issue of permission to performing clinical trials on the list according to appendix 2 in Russian or Belarusian on paper in duplicate and the electronic medium.
7. The complex of preliminary works consists from:
primary examination of the documents specified in Item 6 of this provision (further – primary examination);
specialized examination of the documents specified in Item 6 of this provision, including kliniko-pharmacological and pharmaceutical examination of documents (further – specialized examination).
8. Primary expertize is carried out by the experts who are employees of the Center.
9. Specialized expertize is carried out:
the experts who are employees of the Center;
the experts (expert) included in structure of the groups of experts approved by the Ministry of Health;
the experts (expert) having the special knowledge in scope of medicines of the nosology specified in the draft of the program (protocol) of clinical trial appointed by the Ministry of Health (if necessary).
10. No. 88 is excluded according to the Resolution of the Ministry of Health of the Republic of Belarus of 22.08.2022
11. Primary examination includes check of completeness and correctness of document creation. The term of conducting primary examination shall not exceed 10 calendar days from the date of cash receipt on the settlement account of the Center according to the agreement signed between the Center and the applicant.
In case of positive result of primary examination documents go for specialized examination.
12. In the presence of notes by results of primary examination they go to the applicant in written and (or) electronic type in time, not exceeding 5 working days from the date of their signing.
The applicant resolves comments in time, not exceeding 30 calendar days from the date of their obtaining. The specified term is not set off in aggregate term of carrying out complex of preliminary works.
After elimination of notes expertize of the submitted documents and materials confirming elimination of notes, in time no more than 5 working days from the date of their representation is carried out. In case of elimination of notes documents go for specialized examination.
In case of not elimination of the notes Center within 5 working days from the date of the expiration of fixed term for their elimination in writing notifies the applicant on the termination of complex of preliminary works.
13. Specialized examination includes assessment of documents, confirmatory:
results of preclinical (not clinical) researches of efficiency and safety of medicine;
compliance of documents on aspects of quality of medicine to the requirements established by the legislation;
possibility of receipt of reliable data during clinical trial;
that the expected advantage of medicine for the subject of research and society is higher than the expected (predictable) risk and (or) inconvenience within performing clinical trial;
observance of the rights, safety and wellbeing of subjects of research.
Conducting specialized examination is performed in time, not exceeding 30 calendar days from the date of receipt of the documents, except as specified specified in part three of this Item.
Specialized examination of biosimilar, biological, biotechnological medicines is carried out in time, not exceeding 60 calendar days from the date of receipt of documents.
14. By results of specialized examination by each expert the expert opinion is drawn up.
In the presence in expert opinions of the notes Center sends them to the applicant in written and (or) electronic type (without specifying of experts) in time, not exceeding 5 working days from the date of their signing.
15. The term of elimination of notes shall not exceed 30 calendar days from the date of their obtaining by the applicant. The specified term can be prolonged for a period of up to 60 calendar days based on the reasonable written address of the applicant. The term of elimination of notes is not set off in aggregate term of carrying out complex of preliminary works.
After elimination by the applicant of notes specialized expertize repeatedly, in time, not exceeding 15 calendar days from the date of submission of the documents confirming elimination of notes is carried out. The subsequent notes go to the applicant in case of the additional questions concerning the documents submitted by the applicant in answers to the previous notes.
In case of not elimination of notes of specialized examination carrying out complex of preliminary works stops and the Center draws up the conclusion about availability (absence) of the bases for issue by the Ministry of Health of permission to performing clinical trial in form according to appendix 3, containing conclusions about impossibility of issue of permission to performing clinical trial and impossibility of approval of the program (protocol) of clinical trial. One copy of this conclusion goes to the applicant within 5 working days from the date of its signing, the second copy is stored in the Center.
16. No. 88 is excluded according to the Resolution of the Ministry of Health of the Republic of Belarus of 22.08.2022
17. No. 88 is excluded according to the Resolution of the Ministry of Health of the Republic of Belarus of 22.08.2022
18. By results of carrying out complex of preliminary works as the Center the conclusion about availability (absence) of the bases for issue by the Ministry of Health of permission to performing clinical trial in form according to appendix 3, containing conclusions about is drawn up:
possibility (impossibility) of issue of permission to performing clinical trial;
possibility (impossibility) of approval of the program (protocol) of clinical trial.
The conclusion specified in part one of this Item is constituted in duplicate, signed by the authorized officer of the Center and sealed the Center. One copy of the conclusion within 5 working days from the date of its signing goes to the applicant, the second copy is stored in the Center. Effective period of the conclusion constitutes 6 months from the date of its issue.
19. For receipt of the conclusion of ethical committee of the organization of health care about approval (disapproval) of performing clinical trial, including conclusion about approval (disapproval) of the program (protocol) of clinical trial, the applicant submits documents, materials and information on the list according to appendix 4.
The ethical committee of the organization of health care performs expert evaluation of the submitted documents, materials and information, and also assessment of qualification of researchers and availability of conditions in the organization of health care for performing clinical trials according to requirements of Rules of proper clinical practice (further - expert evaluation) based on the agreement signed between the applicant and the organization of health care.
The expert evaluation and issue of the conclusion about approval (disapproval) of performing clinical trial by ethical committee of the organization of health care are performed according to the procedure and the terms provided by the Regulations on independent ethical committee approved by the resolution which approved this Provision.
Following the results of expert evaluation the ethical committee of the organization of health care makes the decision on approval (disapproval) of performing clinical trial which is drawn up in any form in the form of the conclusion and signed by the chairman.
In the conclusion of ethical committee of the organization of health care results of expert evaluation concerning possibility of providing the rights, safety and health protection of subjects of research, compliance of qualification of researchers and availability of conditions in the organization of health care for performing clinical trials to requirements of Rules of proper clinical practice are reflected and the conclusion is drawn:
about approval (disapproval) of performing clinical trial;
about approval (disapproval) of the program (protocol) of clinical trial.
20. For receipt of permission to performing clinical trial the applicant after passing of complex of preliminary works and carrying out expert evaluation files petition in the Ministry of Health in compliance subitem 9.22.1 of Item 9 of the single list of the ministerial procedures performed concerning subjects of the managing approved by the resolution of Council of Ministers of the Republic of Belarus of September 24, 2021 No. 548.
The center from written consent of the applicant provides to the Ministry of Health access to the documents which are earlier submitted the applicant to the Center for carrying out complex of preliminary works.
21. By results of consideration of the application the Ministry of Health accepts one of the following decisions:
about purpose of clinical trial, issue of permission to performing clinical trial and approval of the program (protocol) of clinical trial;
about refusal in purpose of clinical trial and refusal in issue of permission to performing clinical trial with indication of causes of failure.
The decision made by the Ministry of Health is drawn up by the order which copy goes in written and (or) electronic type to the Center.
22. The Ministry of Health issues to the applicant permission to performing clinical trials in form according to appendix 5 in the terms provided by subitem 9.22.1 of Item 9 of the single list of the ministerial procedures performed concerning subjects of managing or sends to the applicant the written notice of refusal in issue of permission to performing clinical trial with indication of causes of failure.
23. The center based on the order of the Ministry of Health on issue of permission to performing clinical trials within 5 working days from the date of its signing includes data on this clinical trial in the register of permissions to performing clinical trials (testing) of medicines (further - the register).
The register is the information resource containing data on clinical trials on which carrying out permission of the Ministry of Health was issued.
Maintaining the register is performed by the Center.
24. The register joins data about (about):
number and date of permission to performing clinical trial;
name (code) of medicine;
to dosage form and dosage of medicine;
producer of medicine;
applicant;
number and date of the program (protocol) of clinical trial (number and date of edition of the program (protocol) of clinical trial taking into account the made amendments);
name of the program (protocol) of clinical trial;
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