The State Expert Center of the Ministry of Health of Ukraine and Roche Ukraine LLC signed a Memorandum of Understanding and Cooperation aimed at developing the regulatory system and implementing international practices in the field of circulation of medicinal products.
"This is a step towards faster and more predictable regulatory procedures. We are moving towards a model where decisions are based on international experience and mutual recognition of assessment results. This allows reducing unnecessary barriers in processes and accelerating decision-making. Ultimately, this means faster access for patients to quality and innovative treatment," noted the Director of the State Expert Center of the Ministry of Health of Ukraine Edem Adamanov.
"This Memorandum is an important step towards creating a modern and predictable regulatory system in Ukraine that aligns with European approaches. Harmonization of legislation with the EU and implementation of international practices open up opportunities for significantly reducing the time for patients to access innovative treatment. In this context, for Roche this is a long-term partnership with the state aimed at expanding timely access for Ukrainian patients to the innovative therapy they need," said the General Director of Roche Ukraine Dejan Nesic.
As part of the cooperation, the parties will focus, in particular, on the following areas:
- application of the mutual recognition procedure for the results of registration and scientific assessment of the quality of medicines already confirmed by leading global regulators (European Medicines Agency, Swissmedic and others). This will make it possible to optimize regulatory procedures and improve the efficiency of managing changes for medicinal products;
- introduction of modern analytical methods of quality control within the framework of a joint international pilot project with the support of the European Medicines Agency and the World Health Organization;
- exchange of regulatory data using secure digital platforms;
- digitalization of processes, in particular the development of the international eCTD format;
- support for legislative changes aimed at simplifying access of medicines to the market;
- implementation of other initiatives in the field of healthcare.
What does this mean in practice?
For the state – more effective and faster regulatory decisions, reduced burden on the system and approximation to international standards.
For patients – faster access to safe, high-quality and innovative medicinal products.
