CTIS Archives - European Industrial Pharmacists Group (EIPG)

A new member within EIPG


The European Industrial Pharmacists Group (EIPG) is pleased to announce the Romanian Association (AFFI) as its newest member following the annual General Assembly of EIPG in Rome (20th-21st April 2024). Commenting on the continued growth of EIPG’s membership, EIPG President Read more

The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more


ACT EU: the EU’s vision for the future of clinical trials

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by Giuliana Miglierini

Just few days before the entry into force of the new Clinical Trials Regulation and of the Clinical Trials Information System (CTIS) on 31 January 2022, a new initiative has been announced to completely renew the European framework governing how clinical trials are designed and run. The strategic document ACT EU (Accelerating Clinical Trials in the EU) has been jointly developed by the European Commission, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and national regulators with the aim to strengthen the European Union as a leading “focal point” for clinical research at the international level.

ACT EU shall support the achievement of the goals established by the European Pharmaceutical Strategy and the European medicines agencies network strategy (EMANS) to 2025. The initiative will be co-led by the European Commission, EMA and HMA; the proposed governance shall find inspiration on the model already in use by the Clinical Trials Information System, with an EUCTR Coordination Group with an adapted mandate and composition. The individual domains which form the overall matrix will be coordinated by the relevant functions available within the network. The formal public communication phase on ACT EU will start after the official endorsement of the initiative by HMA and EMA.

Six objectives and ten priorities of action for 2022-2023

The ACT EU strategy identifies six different goals for the future of European clinical research. Its leading role shall be optimised through a unified European position on clinical trials at the international level, a better ethical oversight and integration of ethics committees into the clinical trial and medicines regulatory lifecycle. Large-scale multinational clinical trials with broader geographical scope shall be incentivised, while reducing the administrative burden for sponsors and investigators.

A special attention will be paid to the generation of decisional evidence for unmet medical needs, rare diseases, and on vaccines and therapeutics for public health crises and pandemics. A truly high level and coordinated scientific advice is indicated as an important element in order to support the trial and marketing authorisation processes. The strategy confirms the need to adopt new patient-oriented medicines development and delivery models with pro-active engagement of all the stakeholders. The availability of an improved capacity both at the development and regulatory level is also deemed important to achieve the goals of the initiative.

These challenging objectives shall be pursued in years 2022-2023 through the activation of a set of ten specific priority lines of action. An initial exercise to map already existing initiatives within the European medicines regulatory network (EMRN) will be run, that will represent the basis for the consequent development of a governance rationalisation strategy. This might include, for example, the alignment of different expert groups and working parties in the EMRN and ethics infrastructure.

The smooth implementation of the Clinical Trials Regulation shall be monitored using a set of Key Performance Indicators (KPI), still to be developed; the modernisation of the good clinical practices (GCPs) should occur under specific ICH’s guidance. The attractiveness of Europe for larger, multinational trials should specifically address studies run in the academic setting. Furthermore, the academics and non-profit organisations may also play a leading role in the analysis of data arising from clinical trials.

Further actions will include the availability of a multi-stakeholder platform, including patients, and the engagement in the initiative of all enablers by mean of a targeted communication campaign. A tighter coordination of different aspects relevant to the planning of new clinical trials, i.e. the scientific advice on the trial approval and the design of the study, has been also announced. The increasing use of artificial intelligence and/or machine learning technologies in the clinical domain and issues pertaining complex and decentralised trials, as well as the interface between the In Vitro Diagnostics Regulation (IVDR) and the Clinical Trials Regulation will benefit of new targeted methodological guidelines.

As for safety monitoring of clinical trials, the priority is to start its integration into a pre- and post-marketing safety monitoring framework. At the educational level, the competences needed to face this challenging scenario for the future of clinical trials in the EU will require the activation of specific training curricula, inclusive of modules on drug development and regulatory science with links to universities and SMEs.

Four principles to guide all actions

The complexity of the ACT EU initiative will require also the development of a new approach to make available the resources needed to smoothly run all the planned activities, possibly including the exploitation of the expertise external to the European medicines regulatory network. The strategy indicates the intention to adopt a collaborative and integrative approach, so to achieve a large research impact in the EU.

To this instance, the four principles “Do, Require, Influence, Support” have been identified to guide the execution and coordination of the projects, the requirement of specific guidance to address the expectations on applicants/developers/researchers, the availability of key publications and leadership to support the transformation phase at all levels (including patient, the academic, etc.), and stakeholders interactions suited to support all the above mentioned objectives.

The initial mapping of existing activities should also led to the identification of the budget needed for meetings, inclusive also of the activities relative to stakeholder engagement, training, and communication. Any other activities falling outside the optimisation of the already existing ones would be self-funded by the respective organisations (EC/NCA/EMA).

Comments from EFPIA

According to EFPIA, the announcement of ACT EU represents the beginning of an exciting new phase for clinical research in Europe. The industrial association highlights that the innovative design of many clinical trials, especially the complex ones, requires an increased efficiency.


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.