Kazakhstan has recently adopted new rules on clinical trials for medicines and medical devices, including clinical and laboratory examination of in vitro diagnostic medical devices.
The new Order of the Minister of Healthcare of the Republic of Kazakhstan dated December 11, 2020, also sets forth the procedures related to issuing permission on conducting clinical trials and/or examination of pharmaceutics, medicines, and medical devices. The new Order is based on the Code on the public health and healthcare system dated June 7, 2020. The Order also replaces all previous regulations governing the same matters. The new rules take effect in 10 calendar days from the date of first publishing.
General Provisions
The new rules describe the approach to be applied for clinical trials and examinations for medicines and medical devices, including the ones intended for in vitro diagnostics. First of all, the document provides the definitions of the most important terms used in the context of clinical trials including, inter alia, the following ones:
- Informed consent – the procedure of voluntary confirmation of consent for participation in clinical trials communicated by the participant, providing that he/she is duly informed on all significant aspects. Informed written consent should be issued in a form approved by the regulating authority.
- Clinical trials – trials in which a human participates as a subject, intended to identify or verify the safety and effectiveness of means, methods, and technologies of prevention, diagnosing, and treatment of illnesses.
- The protocol of clinical trials – a document, describing the purposes, design, methodology, statistical aspects, and organization of trials.
- Standard operational procedures (SOP) – detailed written instructions intended to ensure consistency when performing certain activities.
- Technical file – a set of technical documentation for a medical device, including the description of a medical device itself, its intended use, and also covering the aspects related to design, manufacturing, and use of a medical device.
The document also provides a list of specific principles to be applied. According to the new rules, clinical trials related to medicines, medical devices, and in vitro diagnostic medical devices should meet the following requirements:
- Investigations should be aimed at the collection of new scientific data and its implementation in healthcare,
- It is important to ensure the protection of interests of persons participating and clinical trials, as well as the confidentiality of medical information,
- It is necessary to obtain the written consent of a participant or his/her authorized representative for participation in clinical trials or use of biological samples and medical information, including for the purpose of filling the biobank for scientific purposes,
- Interventional clinical trials should be carried out on the basis of the permission of the regulating authority.
Clinical trials with regard to medicines and medical devices include four phases. Each phase constitutes a separate clinical examination. In certain cases, several clinical examinations are required for a medicine or a medical device within the scope of one phase. It is also important to mention that in exceptional cases it is allowed to merge first and second phases, and also to reduce the timeframes of clinical trials – providing that the medicinal product in question is being developed by the local manufactures in the context of state scientific research for the purpose of ensuring the biological safety of the country.
All clinical trials should be carried out only when there is a positive conclusion of an ethics commission in place, while in the case of interventional clinical trials the insurance policy covering the life and health of the participant is required. Moreover, any and all clinical trials carried out on the territory of the Republic of Kazakhstan should be registered in the National register of biomedical examinations in accordance with the procedure set forth by the Rules of performing biomedical investigations and the Code.
Obtaining Permission for Clinical Trials
The document outlines the cases when an interested party shall obtain permission to conduct clinical trials. According to the document, with regard to medical devices, such permission is required in the following cases:
- Clinical trials covering implantable medical devices, as well as medical devices classified as Class 3 and Class 2b medical devices under the risk-based classification, except the cases when clinical effectiveness and safety of a medical device in question has been verified in another way.
- Clinical investigations related to medical devices for which the functional characteristics, mode of action, indications for use, or specifics of medical use have not been investigated earlier.
- Clinical investigations of a modified medical device that has been already approved for medical use, in case if the changes made to the device are associated with new functional characteristics, changes to the software, mode of action, intended purpose, or medical use that have not been investigated earlier.
- Clinical investigation of a medical device containing new patient-contacting materials that have not been subject to investigation before.
In order to apply for the appropriate permission, an interested party shall submit an application via the official e-governance portal. Once received, the permission for clinical trials would be displayed in the “online cabinet” of the applicant.
Conclusion of the Expert Organisation
In order to obtain a conclusion of an expert organization with regard to the clinical examination of a medical device a sponsor (an interested party) shall submit to the expert organization the following documents:
- Cover letter, containing the number of the trial, assigned by the sponsor, or international number of the trial (if applicable),
- Application for conducting an examination of the materials of clinical trials,
- Documentation for medical devices (except the ones intended for in vitro diagnostics) in accordance with the standards of Good Clinical Practice in Russian or Kazakh for local manufacturers and in English accompanied with translation in Russian or Kazakh for foreign,
- Technical file for a medical device (the same language rules are applicable),
- A protocol of clinical trials with the justification of the number of medical devices provided for the examination,
- The list of foreign authorities the similar applications have been filed to, as well as the information about the responses, received,
- “ИРК” form in Russian or Kazakh, or in English and the appropriate translation,
- Consent of the chief investigator,
- CV of the investigator,
- An informed consent form,
- Copy of the insurance agreement,
- List of supplementary medical devices and ancillary medicines necessary to conduct clinical trials,
- Notarized power of attorney (in case of the foreign manufacturer),
- Conclusion of the Central or Local commissions,
- Copies of the fee payment confirmation,
- List of the materials submitted.
All documents should be submitted in electronic form. An expert organization shall review the submission and assess the completeness of the documents submitted not later than five business days from the date of receipt, while the applicant shall submit all the documents requested within sixty calendar days from the date of the request.
Summarizing the information provided here above, the new rules adopted in Kazakhstan describe the procedures related to applying for permission for clinical trials with regard to medicines and medical devices. In particular, the new rules outline the scope of documents to be submitted, as well as additional rules and requirements.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.
Sources:
