interoperability Archives - European Industrial Pharmacists Group (EIPG)

EMA’s Q&A on the integration of EudraGMDP and OMS


by Giuliana Miglierini A new step in the integration at the central level of data needed to manage regulatory procedures is going to be activated on 28 January 2022: starting from this date, member states’ national competent authorities (NCAs) shall Read more

Draft Guideline on the acceptability of names for human medicinal products


The scope of this guideline is to provide information on the overall procedure for submitting and reviewing the acceptability of proposed (invented) names for human medicinal products processed through the centralised procedure, as well as detailed guidance on the Read more

Webinar: Antimicrobial Resistance - How do we make Antibiotics Economically Viable again?


Our first EIPG Webinar of 2022 will be held in conjunction with PIER and University College Cork on Tuesday 18th January 2022 (17:00 CET). It is entitled: «Antimicrobial Resistance - How do we make Antibiotics Economically Viable again? ». Our Read more

EMA’s OMS has turned mandatory for centrally authorised products

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by Giuliana Miglierini

Since November 1st, 2021, the use of the Organisation Management Service (OMS) became mandatory for all Centrally Authorised Products (CAPs). The European Medicines Agency (EMA) has published a Questions & Answers document to better explain the new procedures, that will impact the source of data to be used to exactly identify the organisations filing CAP procedures with EMA.

The progression in the implementation of the new provisions

The use of the OMS system is now compulsory for all organisations filing CAP submissions, with the final goal to improve the interoperability of data and the overall efficiency of the regulatory process. Should applicants lack to use OMS data, the relevant applications will be filtered out of the EMA’a validation procedure and sent back to the applicant for remedial action.

The OMS data management service was launched in 2015, and applied to electronic application forms (eAFs) since 2017, and then to many other types of procedures. The availability of OMS data may prove critical to allow the smooth implementation, in early 2022, of the new Clinical Trial Information System (CTIS) and of the Clinical Trial application procedure; during the next year, EMA plans to integrate the OMS also with the Union Product Database (UPD), Variation applications (via DADI project) and Manufacturing/Importers Authorisations (MIAs), Good Manufacturing Practice (GMP) inspections and Wholesale distribution authorisations (via EudraGMDP).

Validated OMS data also need to be used with reference to the “applicant” and “contact person affiliated organisation” sections of pre-submission applications. With the new eAF release (eAF V.1.25.0.0) for Medical Devices, the compulsory use of OMS data will also refer to the “Device Manufacturer”, “Notified Body” and “Companion diagnostic” sections.

Remediation in case of lack to use OMS data includes the insertion of all relevant information in the OMS database before updating and re-submitting the application form. Should applicants not provide sufficient responses, the application may be completely or partially invalidated.

Discussions are undergoing to further extend the use of OMS data also to National Procedures (NP); according to EMA, this may be turn inevitable in the next couple of years, as current eAF forms will be progressively replaced by web-based application forms (through the DADI project), being the latter the same for centrally and nationally authorised products by design.

Any question on the use of the OMS can be sent to EMA’s e-mail addresses specified in the Q&As document.

What is new for applicants

The use of OMS master data (the so-called “OMS Dictionary”) is now mandatory for both Human and Veterinary centralised procedures, namely those making use of eAFs (initial marketing authorization applications, variations applications, and renewals) and well as other procedures (see the Q&A document for more detail). The name and contact details of the contact person are not OMS data, and do not need to be registered with the system; historical organisational data do not have to be registered as well.

To manage a CAP procedure, applicants now need to first register their organisation data with the OMS, or request the update of data already registered by submitting a “Change Request” before filing of the regulatory application.

All requests will be assessed by EMA OMS Data stewards, that will also update data in the systems if the requirements are met. This validation step is fundamental to avoid duplication of data, as all information is checked against the same reference sources (i.e. national business registry, DUNS and/or GMP/MIA certificates) and standardised according to the OMS rules agreed with the Network. The Service Level Agreement provide for EMA to process 75% of OMS requests within five working days and 90% within ten working days. Changes will become visible in the eAF the day after they had been processed, and only upon active refresh of the relevant lists.

The business process which makes use of OMS data is usually responsible to submit such a request, but it can arise also form other parties. More specifically, EMA advises the user who needs to use the data should take the lead in updating it. This may prove relevant, for example, to ensure all manufacturer organisations are included in the OMS Dictionary as needed.

EMA warns applicants to consider the turnaround time for processing the OMS change request when planning to submit applications: even if the application forms will not immediately change and everything may appear as usual, the background process has been now modified and may need additional activities to validate the change requests.

Changes in the eAF templates are planned to remove the free text fields for CAP applications, but until the new models will be available, the free text field for “organisations” should not be used. Planned availability and entry into force of the new versions are December 2021 for Human procedures (v1.26.0.0) and January 28th, 2022 for Veterinary procedures (in line with the veterinary regulation).

How to access the OMS

EMA’s data management system refers to four different domains of data, including the substance, the product, the organisation and referential (SPOR) master data in pharmaceutical regulatory processes.

The SPOR portal provides access to the respective four specific areas of service (e.g. SMS for substances, PMS for products, OMS for organisations and RMS for referential). SPOR is the mechanism used by EMA to implement the ISO IDMP standards, as required by articles 25 and 26 of the Commission Implementing Regulation (EU) No. 520/2012. Organisation master data, even if not covered by ISO IDMP, have been considered by EMA, National Competent Authorities and Industry in Europe to be essential in order to make the master data operating model work.

Applicants need to create an EMA account with SPOR user roles to conduct additional tasks, such as requesting changes to data, translating data or managing user preferences. Already granted credentials to access other active accounts for any EMA-hosted website or online application can also be used. OMS data can now no longer be captured in other EMA databases.

OMS master data include the organisation name and address, labelled by mean of unique identities (ID) (i.e. ‘Organisation_ID’ and ‘Location_ID’). Different categories of organisations are possible (i.e. ‘Industry’, ‘Regulatory Authority’ or ‘Educational Institution’), and of different size (i.e. ‘Micro’, ‘Small’, or ‘Medium’). The role played by a certain organisation is context-specific and cannot be defined within the OMS.


The Swiss interoperable national eHealth infrastructure

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by Giuliana Miglierini

The new model of a personalised and interconnected healthcare asks for the interoperability of data in order to precisely access all the information needed to make the correct diagnosis and decide the most appropriate treatment for each patient.

Interoperability is at the core of the new Swiss strategy used to build the national eHealth infrastructure; the strategy has been developed by a team of scientists from the University of Geneva (UNIGE) and the University Hospitals of Geneva (HUG), in collaboration with the Swiss Institute of Bioinformatics (SIB) and the Lausanne University Hospital (CHUV), under the auspices of the Swiss Personalized Health Network (SPHN) and in close collaboration with representatives from all five Swiss university hospitals and eHealth Suisse.

A journey started in 2015

The new national infrastructure strategy will be adopted by all Swiss university hospitals and academic institutions. The announcement of the new strategy follows a long-lasting work to adequate the Swiss legislation, started in 2015 with the approval of the new federal law on patients’ electronic health records (EHR) (see more on Health Policy).

According to the Swiss law (entered into force in April 2017), adoption of the interoperable infrastructure is voluntary for ambulatories and private practices. In the same year, the Swiss Personalized Health Network (SPHN) also created by the government, an initiative led by the Swiss Academy of Medical Sciences in collaboration with the SIB.

Despite major investments over the past decade, there are still major disparities”, says Christian Lovis, director of the Department of Radiology and Medical Informatics at the UNIGE Faculty of Medicine and head of the Division of Medical Information Sciences at the HUG. “This is why we wanted, with our partners and the SPHN, to propose a strategy and common standards that are flexible enough to accommodate all kinds of current and future databases.”

A semantic framework integrating with the existing standards

The new infrastructure will be implemented to complement the existing tools already used by the Swiss eHealth community. Synergy and flexibility are the principles that inspired its development, which is based on a common semantic framework that does not aim to replace existing standards. The final target is to make a step forward towards the application of personalized medicine, so to better respond to the needs of both patients and the Swiss healthcare system. The new infrastructure has been officially presented by an article published in the JMIR Medical Informatics.

Its stepwise implementation has already started at mid-2019, within the framework of the Swiss Personalized Health Network. “Swiss university hospitals are already following the proposed strategy to share interoperable data for all multicentric research projects funded by the SPHN initiative”, reports Katrin Crameri, director of the Personalized Health Informatics Group at SIB in charge of the SPHN Data Coordination Centre. Some hospitals are also starting to implement this strategy beyond the SPHN initiative.

In the JMIR Medical Informatics article, the authors describe the process that led to the new strategy, starting from the deep analysis of various approaches to interoperability, including Health Level Seven (HL7) and Integrating Healthcare Enterprise (IHE). Several domains have been also addressed, including regulatory agencies (e.g. Clinical Data Interchange Standards Consortium [CDISC]), and research communities (e.g. Observational Medical Outcome Partnership [OMOP]).

The semantics of the infrastructure was mapped according to different existing standards, such as the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT), the Logical Observation Identifiers Names and Codes (LOINC), and the International Classification of Diseases (ICD).

A resource description framework (RDF) allows for the storing and transportation of data, and for their integration from different sources. Data transformers based on SPARQL query language were implemented to convert RDF representations to the required data models.

A common semantic approach

The three pillars on which is built the new infrastructure reflect the three essential components of communication: the commonly shared meaning we give to things, a technical standard producing the “sound” and the organisation of the meaning and sound with sentences and grammar so that communication becomes intelligible. The same occurs with data, where the agreed semantic significant is used to represent conceptually what has to be communicated. “Then we need a compositional language to combine these meanings with all the freedom required to express everything that needs to be expressed. And finally, depending on the projects and research communities involved, this will be ‘translated’ as needed into data models, which are as numerous as the languages spoken in the world”, explains Christophe Gaudet-Blavignac, a researcher in the UNIGE team.

Unification of vocabularies instead of creation of new ones has been a major target for scientists involved in the effort; this new common vocabulary will be now used to communicate within any type of grammar, without need to learn a ‘new language’. “In this sense, the Swiss federalism is a huge advantage: it has forced us to imagine a decentralised strategy, which can be applied everywhere. The constraint has therefore created the opportunity to develop a system that works despite local languages, cultures and regulations” says Christian Lovis.

This approach is expected to provide a robust guarantee of mutual understanding and significant time savings for researchers called to prepare relevant documentation, as specific data models will be applied only as the last step of the procedure. The chosen modalities shall provide the needed flexibility to adapt to the formats required by a particular project, for example those typical of the FDA in the case of collaboration with an American team.

The challenges of interoperability

The new infrastructure takes also into due account the many challenges related to the sharing of data. Instruments that create interoperability and their implementation have to face the regulatory framework that governs data accessibility and protection, for example with reference to the GDPR regulation on personal data. “The banking world, for example, has long since adopted global interoperability standards, – comments Christophe Gaudet-Blavignac. – A simple IBAN can be used to transfer money from any account to any other. However, this does not mean that anyone, be they individuals, private organisations or governments, can know what is in these accounts without a strict legal framework

Interoperability is even more a challenging goal to be achieved in the biomedical field, due to the very great heterogeneity of data involved in the diagnosis and treatment of a certain disease, and the consequent need to interconnect and integrate many different systems to achieve a robust communication. This issue has been made fully explicit during the pandemic, when a huge amount of data of different types were produced: even if lifting all technical, legal and ethical constraints to their interoperable use, the data remain difficult to analyse because of semantic ambiguities, notes the Swiss scientists.

Big data and new technologies

The digital opportunity in the Swiss healthcare system has been also examined by PricewaterhouseCoopers (PwC) in a report of February 2019. Many new informatics technologies may prove useful to boost the eHealth Swiss landscape, suggest the analysts, from the use of big data and data management to the spreading of wearable devices and sensors among patients.

According to PwC, the first ones are expected to transform the diagnosis process from a subjective experience to an objective, data-driven process. This would allow also to improve its transparency, providing a rationale for the choice and effectiveness of treatments.

Wearables and sensors are expected to further expand this vision to self-diagnosis, monitoring and remote treatment, thus supporting the transition towards a prevention-based healthcare industry pursuing very early-stage identification of pathologies and related therapeutic interventions.

The PwC’s study – comprehensive of 38 interviews with patients and industry experts – ran in collaboration with the University of St Gallen. Six different categories of patients were identified: the Health enthusiast, the Sceptic, the Healthy Family, the Chronic, the Frail elderly and the Mentally stressed. For each of them, a map identifying pain points along the patient journey were also derived in relation to the domains of Time, Emotions, Information and Resources.

Lack of trust in the healthcare system, insufficient availability and accuracy of resources and the time is spent in waiting rooms are among the main issues experienced by Swiss patients, according to PwC. All of them can be tackled using the new digital technologies, including big data, wearables and sensors, artificial intelligence, robotics, telemedicine and mobile health, digital simulation, body augmentation and remediation.