Information management has become an integral part of the European Medicines Agency's (EMA) mission to promote and protect public and animal health. This is driven by the increasing importance of interconnected information technology (IT) systems for managing and sharing information on medicines, the growing range of EMA's external users with different information requirements and the overall digital transformation of society and regulation.
The European medicines regulatory network relies on IT services to support all activities related to the authorisation and supervision of human and veterinary medicines in the European Union (EU). EMA makes available and maintains many of these IT services.
EMA staff and experts need IT solutions from EMA to carry out their core regulatory work. Many external stakeholders also increasingly rely on EMA's IT systems.
Pharmaceutical companies expect IT systems that help them meet their regulatory requirements more efficiently and cost-effectively.
Patients and healthcare professionals demand timely access to public information on medicines, so they can make their own decisions.
The globalisation of medicines means that EMA needs to share more information with regulatory authorities worldwide.
Academic sponsors rely on EMA's services, and the information EMA holds is also relevant for academic research.
Information management strategy
To respond to these demands, EMA adopted an EMA Information Management Strategy in December 2015:
The strategy focuses on optimising EMA's IT infrastructure and information services and driving the overall digital transformation of EMA.
Its three main objectives are to:
- deliver IT solutions required by EU law;
- share more information on medicines;
- establish new EMA information services and improve existing ones.
The main expected benefit for partners and stakeholders is that EMA will be able to share more information, guarantee data quality and ensure a continuous service. This will make it easier and more efficient to obtain, maintain and analyse reliable data on medicines.
EMA wants its Information Management Strategy to support the implementation of other strategies, programmes and projects in specific areas of EMA business, which often involve a major IT component. These include:
- the EU Telematics strategy, which aims to establish and maintain common IT systems together with EMA's partners in the European medicines regulatory network;
- EMA's approach to implementing the ISO IDMP standards through the management of master data on medicinal products;
- various EMA programmes and projects delivering new or enhanced IT systems in defined business areas, such as clinical trials, pharmacovigilance and veterinary medicines.
The three main objectives drive a number of key deliverables. The table below summarises these:
|Deliver solutions required by EU law|
Launch central repository for periodic safety update reports (PSURs)
Deliver a European clinical trial system
Deliver enhanced EudraVigilance systems for human and veterinary medicines
Establish reliable master data management services
Deliver adapted information services for veterinary medicines
PSUR repository in mandatory use since 13 June 2016
EU clinical trial portal and databse should be available for audit by August 2017
EMA aims to launch a new EudraVigilance system with enhanced functionalities in November 2017
EMA is implementing ISO IDMP standards based on substance, product, organisation and referential (SPOR) master data and establishing SPOR business services to manage these
EU Veterinary Medicinal Product Database launched in October 2015
|Share information on medicines|
Provide access to clinical study reports
Under EMA's policy on clinical data publication, EMA publishes clinical reports submitted under the centralised procedure from October 2016
EMA is working towards an improved corporate website and launching a European medicines web portal with information on all medicines authorised in the EU
EMA is improving provision of data and analytical capabilities to stakeholders
|Establish and improve EMA's information services|
Improve EMA's technology landscape by means of enterprise architecture
Strengthen information security
Establish a set of standard information services
EMA is working on setting up new information governance at EMA
EMA is implementing an information security management system compliant with ISO standards for information security management
EMA is developing a portfolio of information services based on reinforced information governance and security
Under the third objective, EMA is establishing a portfolio of information services to support EMA's business processes and address the information needs of external users.
This involves improving and establishing several IT systems at EMA.
The below table describes the information services targeted at external users and their purpose.
|User registration & profile management||For individuals and organisations to register to access EMA information; includes authentication, declaration of interests and electronic signatures|
|Application & request submission||For applicants and requestors to apply for and receive structured data as part of regulatory procedures|
|Master data management||For users to submit applications or requests containing SPOR master data terms in a structured and reusable way; allows sharing and management of master data|
|Adverse drug reaction (ADR) collection||To support collection of data on safety of medicines from marketing authorisation holders, clinical trial sponsors and national competent authorities and from scientific literature|
|Collaboration||For users to access, modify and share documents for virtual or physical meetings through telecommunications and messaging services|
|Information provision||To provide information to stakeholders, including information on medicines and regulatory actions|
|Analysis||For stakeholders to access structured and unstructured data and produce aggregated data including complex statistical metrics|
|Document management||For the creation, management and sharing of electronic documents, allowing for storage, retrieval, tracking and archiving at EMA and across the regulatory network|
More information on the process and timetable for establishing and improving these information services, including a high-level roadmap, is available in the Information Management Strategy.
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