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The State Expert Center of the Ministry of Health of Ukraine has received the official status of ICH observer

26 November 2021
33

Information about this has now been published on the official website of the International Council for Harmonization of technical requirements for the registration of medicines for humans (ICH).

“The ICH Assembly welcomes a new member – the Federal Commission for protection against risks in the field of sanitary control (COFEPRIS, Mexico) and three new ICH observers: the authorized body in the field of medicines (EDA, Egypt), the Food and Drug Administration (FDA, Indonesia) and the State Expert Center of the Ministry of Health (SECMOH, Ukraine). Thus, ICH already has 19 members and 35 observers”, the press release on the official ICH website says.

The relevant decision was made on November 17, 2021 at a meeting of the ICH Assembly, where a presentation on the center’s activities was presented. The ICH member countries unanimously voted to grant the State Expert Center of the Ministry of Health of Ukraine an observer status.

The official name of the Ukrainian Expert Center in ICH is the abbreviation in English: State Expert Center of Ministry of Health of Ukraine (SECMOH, Ukraine).

In his address to the staff of the Center on the occasion of the Assembly’s decision, SEC director Mykhailo Babenko thanked the employees for their tremendous work during the year, which resulted in obtaining the above-mentioned status.

“Our new role has sent a clear signal to the whole world that the State Expert Center and the Ministry of Health of Ukraine are making every effort to guarantee our citizens the highest international standards of safety, effectiveness and quality of medicines. Participation in ICH activities will give us the opportunity to develop, exchange experience, improve our work, and become even more open and understandable for applicants”, he said.

Today, the International Council for Harmonization of technical requirements for the registration of medicines for humans (ICH) is one of the most influential formats for interaction between regulatory authorities and representatives of the pharmaceutical industry in the world.

The main goal of the Council, established in 1990, is to strengthen the health of the world’s population by internationally harmonizing technical requirements for the registration of medicines.

The competent authorities of the EU (European Commission/EMA), USA (FDA), Switzerland (Swiss Medic), Japan (MHLW/PMDA), Australia (TGA), Canada (Health Canada), Great Britain (MHRA), Israel (CPED) and others participate in ICH activities.

It should be recalled that the Center submitted an application for observer status to ICH in 2021. After a preliminary assessment by the Secretariat, it was submitted to the ICN Steering Committee for consideration, which concluded that the application of the State Expert Center of the Ministry of Health of Ukraine meets all the criteria for the right to be elected.

According to the Charter, voting took place at the nearest meeting of the Assembly on November 17-18 in a virtual format. All member states voted unanimously to grant the SEC an observer status of ICH.