We tell about one of the new departments in the Medical Regulatory Unit, which was established a year ago. The specialists of the Department, that is 10 employees, work in several directions:

• Registration dossier information management, and transition to electronic registration dossier, and distribution of approved registration documentation.
• Preparation of registration dossiers to the markets of CIS and far-abroad countries (more than 400 pcs in 2018).
• Work of factory library in Kyiv and Smuglyanka Holiday Resort.

One of the important areas of work of the Department is the transition to electronic registration dossier in the product life cycle, which will make it possible to improve the information search and management, because the total number of dossiers is constantly increasing – today there are about 1,300 in all markets. And the work is continuing actively. For example, all dossiers for new medicinal products (Ukrainian market) are created only in electronic format. Products of the existing nomenclature (Ukraine) are gradually transferred to electronic form. As for other markets – countries of CIS and Europe, Iraq, Vietnam – there will also be a gradual transition to the electronic dossier after the planned 2019 system update. By the end of the year, new registration dossier virtual structures (14 pcs) will be created for these countries.

Another important area of work is the electronic distribution of approved registration documentation. It is planned to launch in the second half of 2019.

Work-related issues

It is this Unit that collects information about the products produced by Farmak for the formation of registration dossier, so it closely cooperates with other divisions and departments. For example, our specialists in preparing dossiers send almost 10 memos to obtain information about one product. They process information about 20-25 products within a month. The amount of work also depends on the requirements of the country for which the dossier is being prepared. For example, Mongolia requires a small list of documents, but in Kazakhstan, Belarus and Moldova there are more stringent requirements, and then you need to collect a lot of data. The lion’s share of the work is the dossier analysis: the information already contained in it must be checked in accordance with the current requirements of the country for which the dossier is worked out, one should get oriented in what documentation should be provided or updated (in comparison with the current Ukrainian dossier), then a request is provided to the units to obtain the necessary information; for all countries, it is necessary to translate into Russian or English. Dossiers are prepared in paper and/or in electronic form, depending on the requirements of the country. Work on one dossier can last up to a week.

Quote

Our work is quite standard and routine. However, the biggest challenge for me is the transition to electronic document management: we are seeking to introduce electronic dossiers for all markets.

When there are emergency situations and you need to promptly collect certain information, but other departments, because of their employment, can not always quickly provide us with it, we work as a team, trying to help each other, prioritizing the work. Our team is very close-knit and friendly, there is mutual respect. I think I’m very lucky with that. I would like to wish my colleagues creative inspiration, faith in what they are doing and the desire to do it. Sometimes even the most difficult tasks can be performed, if you believe in yourself and do not even allow thoughts that something may not work.

Unit structure

Medical Regulatory Unit was established as a successor of the Unit of Registration and Regulatory Requirements that had been working for 7 years. Taking into account external and internal challenges, as well as a more stringent regulatory policy in the pharmaceutical industry, the updated Unit expanded its functions. Today, it consists of 5 departments:

• Clinical Research Department.
• Medical Regulation Department.
• Ukraine Registration Department.
• Packaging and Design Department.
• Department of Registration Dossier Information Management.

In general, about 50 specialists work here.

Partnership and cooperation for results

Our role in the process is between R&D and industrial output of products. Our input is a semi-product from the developers, and output is the permits for the finished approved product.

The work of the Unit staff begins after R&D specialists complete the pharmaceutical development of new products or improvement of existing ones. Next, the planning and product research stage begins in the Medical Regulatory Unit. These are clinical and medical justifications, preparation of documentation of registration dossier – that is, collection and structuring of all information obtained in the cycle of development and research. Then, a prepared package of documents in the structure of Registration Dossier is submitted for registration to the regulatory body of Ukraine to obtain registration (marketing authorization for the Ukrainian market). After obtaining the “product passport” – registration certificate – the product can be used in medical practice, that is, be sold and used by the consumer.

At Farmak, the product is prepared for industrial manufacture. And here again you need the help of our experts – Packaging and Design Department prepares package design and layouts, and the Department begins the processes of managing the registered information of the registration dossier – from preparation of the Order on the introduction of documentation and provision of units with it, to preparation of documents for entering other markets.

More than 15 structural units of Farmak are involved in the whole cycle, from product planning to its implementation. And our result would not have been possible without joint communication and cooperation with partner departments.

Continuous work

The projects managed by the specialists of the Unit are complex and quite long-term, because every step, every action, every procedure is an additional guarantee that the end user will receive high-quality and safe medicinal products. Some projects may be implemented within 1.5 years. And when it comes to medicinal products undergoing clinical trials (most products still need clinical trials), the process can last up to 3 years.

The development and registration cycle of generic medicinal products, making up the vast majority of our products, takes 1.5 to 3.5 years. Work with original medicinal products is expensive and long-lasting, and can last 7 years or longer.

Challenging projects

One of the challenges for the Unit, especially for the Clinical Research Department, was the project to confirm the bioequivalence of our existing solid oral forms. Farmak was one of the first to conduct the relevant trials and procedures to bring the old nomenclature in line with modern requirements. We started with 15 products important for the Company. Clinical trials, registration and other necessary procedures took place.

Our specialists also played an important role in the projects on technology transfer products implementation (enoxaparin, insulin). Together with the regulator, we were looking for the ways to register such products in Ukraine, in the practical absence of regulatory field and rules.

Figures

• 265 dossiers for medicinal products registered in Ukraine.
• 22 technical files for medicinal products and dietary supplements.
• 165 dossiers for API.
• 1,300 dossiers in all markets.

Some of the registration dossiers continue to be kept in paper form, but we are completing work on the project to move over to the electronic document management system of registration dossier, including other markets. It is for the intensification of these works that a new Department of Registration Dossier Information Management was created in the updated structure of our Unit.

Everything included in the Dossier

The entire cycle of medicinal product creation and research is recorded in the dossier. Thus, each new product that enters the market receives its first registration for 5 years. However, as practice shows, in years 2-3 there are certain changes: the supplier of a certain substance used in the medicinal product may change, there are changes in labelling and packaging, so all this information needs to be entered in the dossier. In 5 years, the relevant regulatory authorities again review the dossier, evaluate the product (the re-registration process takes place), if during this time there was no risk predominance over benefit when using the medicinal product, then the medicinal product obtains an unlimited registration in Ukraine. In the future, the life of the product continues in the life cycle, and the specialists of our Unit maintain the dossier up to date by making the necessary changes.

Each dossier is 5-7 folders with documents, the largest dossier consists of 70 folders.

The key responsibility for the quality in the Company is imposed on the Quality Director. The operation of such unit does not diminish the role and responsibility of other employees Service. It includes the regulatory compliance of all quality management systems, independent control at all production stages, and certification of products by the Qualified Person, but, on the contrary, is a central link in the multifunctional quality chain – from the development of a medicinal product to its delivery to consumer.

“Quality is not only a value and system for Farmak, it’s a business philosophy. Indeed, quality is inherent not only in the product, but also in all management and production processes of the Company“, says Olga Oleksiichuk, Quality Director of Farmak.

The Company has developed the pharmaceutical quality system over the past 23 years which was recognized at the European level. Today, national GMP certificates have been issued to all manufacturing sites 14 of which are certified by the European regulatory authorities of Croatia, Poland, Germany. 95% of Farmak products are manufactured on these certified sites. There is no any other pharmaceutical company in Ukraine which is recognized at such European level. Our quality management systems for medicinal products and dietary supplements meet ISO 9001, ISO 13485, ISO 22000 and make it possible to develop these areas of activity. “These systems guarantee the quality of our products and create consumer confidence”, says Olga Oleksiichuk. And this is not just our achievements. Such results are achieved due to highly skilled professionals.

Today, the Quality Director Service employs about 230 persons. It consists of: two departments on the Kyiv site: the Quality Control Department and the Quality Management Department, as well as the Certification and Release Department; the API Quality Department in Shostka is a small quality service on the API manufacturing site in charge of quality assurance and quality control, as well as product release.

Quality means requirements, expectations, opportunities.

“We understand our responsibility both to the regulatory authorities and to the Company. Our Service has implemented regulatory requirements, as well as expectations of consumers and partners in our activities“, says Olga Oleksiichuk.

One of the main functions of the Quality Service is to contribute to the achievement of the Company’s strategic goals, in particular to expand our presence in foreign markets with rigid regulatory systems. This is a new level of quality standards and new challenges for the Company’s team as a whole.