14 April 2022 the Medical Devices Subcommittee meeting will take place re doing business during…
Health Care Committee
It is the most numerous Ukraine’s community of pharmaceutical and medical devices manufacturers, Clinical Research Organizations and other clinical trials industry companies.
Advocacy Diary
Meetings
Committee board
Chair
GeorgiyViktorov
Abbott Laboratories GmbH
AndriiStognii
Santen Oy
EvgeniyGaidukov
LLC AstraZeneca Ukraine
Registration Subcommittee
AngelaKupych
Farmak JSC
Medical Devices Subcommittee
HennadiySergeev
BMT UA
Clinical Trials Subcommittee
AndriiBiliavskyi
AbbVie Biopharmaceuticals GmbH
Committee priorities
Advocating for establishing a new State Control Body
Contributing to the continued digitalization in the pharmaceutical sector
Supporting the implementation of the new Law of Medicines providing expert contributions to the development of new legislation needed for this purpose
Advocating for increasing the share of state participation in healthcare expenditures to expand patients` access to treatment via state funding including a comprehensive, transparent, HTA-based list of medicines in the Single Positive List
Supporting the EU integration process and harmonization of Ukrainian legislation with EU requirements
Successes
Progresses
Committee companies
Clinical Trials Subcommittee
Medical Devices Subcommittee
Registration Subcommittee
Clinical Trials Subcommittee unites CRO and R&D pharmaceutical companies. The main activity of the Subcommittee is focused on the conduction of clinical trials in Ukraine, harmonization of the regulatory base in the respective sphere by cooperating with the state bodies.
Andrii Biliavskyi – Head of HCC Clinical Trials Subcommittee.
Subcommittee priorities for 2024 were defined as:
- Facilitating the restoration of CT in Ukraine, and further adaptation to the current situation
- Supporting the implementation of the new Law of Medicines & State Control Body ‘Ukraine Medicine Agency’ (SCB UMA) for CTs
- Introduction of modern methods and approaches to conducting CT (advanced therapy, decentralized CT, etc.)
- Optimization of the taxation within the PTTACUP programs via amendment to the Tax Code of Ukraine
- Amendments to the Criminal Code of Ukraine
Subcommittee meetings take place upon necessity. Medical Devices Subcommittee is chaired by Hennadiy Sergeev.
The main activity is focused on the import and circulation of medical devices and equipment at the Ukrainian market.
Subcommittee priorities for 2024 were defined as:
- Introduction of new technical regulations for medical devices
- Development of a sustainable communication and control system for the medical device register
- Measures to promote anti-counterfeiting and anti-gray import of medical devices
- Improvement of public procurement procedures for medical devices
- Contributing to the development of the Draft Law on medical devices
Subcommittee meetings take place upon necessity. Registration Subcommittee is chaired by Angela Kupych.
The Subcommittee’s activity is focused on medical drugs’ accession and circulation issues.
Subcommittee priorities for 2024 were defined as:
- Leading the development of legislation regarding building the capacity of a new body
- Support the state with the necessary expertise to ensure the new body is transparent, competent, digitalized, capable, and efficient
- Focus on the implementation of e-CTD, e-consent, and other digital tools
- Endorse the submission of the documents to the state bodies through electronic channels becoming the primary way of submission
- Continue to contribute to the legislation of acceptance of EU and SRA GMP certificates without additional procedures in Ukraine
- Advocating business interests in the process of the establishment of the Ukrainian National Medicines Verification Organization (UNMVO)
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