Information management

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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:

Key deliverables

The three main objectives drive a number of key deliverables. The table below summarises these: 

ObjectiveKey deliverablesStatus
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

 

 

 

 

 


Provide information on medicines available in Europe

 

 

 

 

 
Increase value of information through business intelligence and analytics

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

 

Information services

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. 

Service namePurpose
User registration & profile managementFor individuals and organisations to register to access EMA information; includes authentication, declaration of interests and electronic signatures
Application & request submissionFor applicants and requestors to apply for and receive structured data as part of regulatory procedures
Master data managementFor 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) collectionTo support collection of data on safety of medicines from marketing authorisation holders, clinical trial sponsors and national competent authorities and from scientific literature
CollaborationFor users to access, modify and share documents for virtual or physical meetings through telecommunications and messaging services
Information provisionTo provide information to stakeholders, including information on medicines and regulatory actions
AnalysisFor stakeholders to access structured and unstructured data and produce aggregated data including complex statistical metrics
Document managementFor 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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