Twinning solution

Strengthening the Capacity for the Analysis of Electronic Healthcare Data

Twinning type

Main policy priority

Better data to promote research, disease prevention and personalised health and care


Medicines and Healthcare products Regulatory Agency (MHRA) (UK)


Agencija za lijekove i medicinske proizvode (HALMED) (Croatia)

Short description

The purpose of SCAN is to ensure knowledge transfer from MHRA to HALMED with the aim of setting up a sustainable system for using the existing Croatian Central Health Information System (CEZIH) for observational research, generation of scientific evidence on drug-related issues and post-marketing drug regulatory decision-making by using real-world data. So far, there is a vast amount of underutilized electronic healthcare data (including administrative healthcare databases, insurance databases, electronic health records, and different types of registries) in Croatia.
MHRA’s extensive experience in the use and analysis of electronic healthcare data for monitoring medicine safety will thus be used to help set up a similar process within HALMED’s Pharmacovigilance department, including organisational, technical and financial aspects of the process. The project will be divided into 4 tasks in order to map both existing systems and perform gap analysis, followed by a case study done by HALMED and supervised by MHRA.
Eventually, the Croatian drug regulatory authority will improve its capacity to use available electronic healthcare data for a variety of different use cases, and therefore, generate better informed regulatory decisions.


Twinning activities

The main tasks were as follows: 1) to get an overview of all aspects of MHRA process for electronic healthcare data analysis and interpretation; 2) to perform gap analysis of HALMED system in order to help streamline further development of the process within HALMED; 3) to simulate and test the process steps with real data; 4) to develop strategy document for inclusion of electronic healthcare data analysis into HALMED practice.


MHRA provided an overview of the process by which research studies using electronic healthcare records, such as the Clinical Practice Research Datalink (CPRD), are conducted. This included information on how topics for study are identified, assessment of feasibility, protocol development and approval, data extraction and management and preparation of programs for analyses and subsequent interpretation. Details on the purpose of and types of studies conducted (e.g. signal evaluation, drug utilisation) were also presented. Information on employee requirements and competencies in terms of FTEs, qualifications and prior experience are provided as well. Legal requirements (e.g. data protection), compliance, inspection and quality documentation was discussed as well. Finally, triggers for particular analyses, communication on the CPRD data within and outside the MHRA, strategy for further development of the process, as well as technical development of the CPRD and policy aspects were also examined. HALMED provided baseline analysis on available Croatian electronic healthcare data sources, data structure and organisation, legal requirements for electronic data use, prerequisites and timelines for data retrieval. This was communicated and discussed with MHRA experts in order to jointly perform gap analysis (SWOT analysis) that will help streamline further development of the process within HALMED. During the project it was planned for HALMED to perform a case study on the safety issue relevant for HALMED using Croatian healthcare data. HALMED planned to simulate and test the process steps with real data including prioritisation and decision on the safety issue to be addressed, definition of outcomes, assessment of applicability and type of data to be used, request for data communicated to national health insurance fund, data analysis, statistical analysis, interpretation and communication of results. Process steps were planned to be supervised by MHRA with corrections and suggestions to be provided based on their experience in all phases of the process. Initial project timelines have been delayed by the late start of the twinning. For meeting the previously set timelines, task 3 has been adapted: HALMED re-used one of the studies done by MHRA and adapted the study protocol according to the available Croatian data taking into account its structure and availability. Based on the results of the gap analysis and the case study HALMED developed a concept and plan for the implementation of a process for electronic data analysis into HALMED’s routine practice of drug safety monitoring. An internal (HALMED) strategic document was developed, including plan for capacity building, as well as communication strategy to stakeholders outside HALMED in order to highlight and explain the importance of such processes and to ensure the sustainability of the project results.

Added value and benefits

The main added value of the twinning, from the perspective of the adopter, was the possibility to collaborate with experts with extensive real-life experience in the field. Their perspective on barriers and facilitators of the process and experience with day-to-day use of electronic health data for regulatory drug-decision making was the most important part in creating a realistic, feasible and sustainable plan for implementation of the process into adaptor’s routine work. Practical issues and problems in daily work are sometimes overlooked in the big picture and this twinning addressed those issues as well adding to its overall value.

Barriers and success factors

It is very important to highlight that commitment from both participating organisations has been achieved prior to proposal submission, promising early successful adoption and avoiding barriers to implementation. Both partners were dedicated to project respecting the timelines and tasks that were agreed in advance and clearly communicated. Communication between partner was continuous, meetings were scheduled and prepared in advance, however, some ad hoc meeting were prepared when it was necessary.


The role of any drug regulatory agency is to protect and improve the nation’s health through expertise, data and regulation, working in close partnership with other health and care bodies. In an ongoing effort to use all available assets for fulfilling its role, general trend, supported by the European Medicines Agency, is to build regulators’ capacity for using Real-world data (RWD) to strengthen regulatory decisions and communications, ensuring better health outcomes for EU patients. RWD analysis has been part of HALMED’s Pharmacovigilance department safety assessment in several occasions, enhancing the need to become part of the regular practice for ensuring safe use of medicines. As a twinning outcome, a strategy will be implemented addressing organisational, economic and policy aspects of the process.