Across the globe, health authorities are embracing a digital trend that prioritizes centralizing, standardizing, and integrating regulatory data and submissions. These collective efforts seek to simplify and optimize the regulatory process and foster increased cooperation between organizations. Digital transformation in regulatory practices is not just technical—it’s a cultural shift towards transparency and cooperation in global health. But the more we centralize and streamline healthcare data, the less room there is for errors. Precision is more than a goal; it's a requirement.

Tigermed, a leading international clinical research organization (CRO), has a proven track record of guiding pharmaceutical sponsors through the complexities of the EU regulatory landscape. Our expertise extends to seamlessly integrating new regulatory systems/platforms and navigating evolving compliance guidelines. With our comprehensive support, sponsors gain a clear understanding of intricate regulatory workflows, sidestepping common pitfalls that could derail project timelines. By leveraging Tigermed's full-service approach, sponsors can confidently advance their EU projects while staying on schedule and fully compliant.

What is Organisation Management Service (OMS)?

In November 2021, the EMA began requiring OMS data for Centrally Authorised Product applications. The agency has steadily introduced OMS for electronic applications since 2017, intending to eventually mandate its use.

The OMS requirement was spurred by the EMA's ongoing effort to implement the International Organization for Standardization (ISO) mandated standards for identifying medicinal products (IDMP). ISO IDMP requires standardized definitions in identifying and describing medicinal products for human use to optimize the sharing of product
information.

To apply ISO IDMP standards, the EMA created a data management system called the SPOR portal (substances, products, organisations, and referential). By centralizing and standardizing data, the EMA sought to increase regulatory efficiency and facilitate information sharing.

While ISO IDMP did not require organization data, it was recognized as essential for the SPOR portal master dataset and included marketing authorisation holders, sponsors, regulatory authorities, and manufacturers.

OMS manages the organizational data component of the SPOR portal master dataset, called The OMS Dictionary. This system provides a single source of validated organization information referenced for regulatory activities. Organizations are categorized in OMS by type (e.g., educational institution) and organizational size.

OMS Requirements for Regulatory Submissions

Sponsors must ensure that their OMS submissions align exactly with EMA guidelines, as any discrepancies or outdated information can lead to application delays or rejection. Strict adherence to the guidelines can create challenges as sponsors navigate the detailed and complex registration process. OMS requires numerous supporting documents for guideline compliance, requiring significant attention to detail.

The regulatory procedures described above require sponsors and other stakeholders to register their organization data with OMS and keep this information updated. To change existing organization data with OMS, sponsors must submit a “Change Request” before any EMA application submission.

Navigating an OMS Change Request

Log into the OMS portal with an EMA account.

To create a new organization or update the OMS database, the user will need an EMA account and will need to complete the appropriate SPOR user registration.

EMA accounts are unaffiliated with any organization until users select their existing organization within OMS or create a new one. Organization affiliation requires that the user obtain access through SPOR National Competent Authority or Industry user roles with EMA Account Management.

Only users with this approved access and affiliation level in OMS can request changes to published records.

Search for the organization in OMS.

The user can search for organizations in the OMS portal under the Organisations tab on the OMS homepage.

Complete and submit the change request form.

If no results appear in the search field, a new organization registration must be submitted. New organizations can be registered by clicking “Request New Organisation” in the bottom right corner.

The user will then need to populate the registration form and attach appropriate supporting documentation. Once submitted, the request status can be tracked under “View Requests” on the OMS homepage.

Existing organizations will populate the search page, and the user can click the spyglass icon on the right to go to the organization’s information page. Once there, the user can click the “Request change” button, populate the form with the reason for the change request, and attach supporting documentation.

Additional guidance is provided in the “Documents” section of the OMS portal under “E-OMS Change Request.”

Streamlining OMS Change Requests with Tigermed

Sponsors looking to break into the EU market greatly benefit from having a partner with expertise in EMA regulations and procedures, including OMS. Without this expertise, several problems can arise while setting up or changing organizational information in OMS.

Case Study: Resolving OMS Submission Errors to Prevent Delays

The Challenge

Consider a case where a Tigermed client independently initiated their OMS registration, successfully completing the EMA's general information requirements. However, they overlooked the correctness of crucial supporting information—the court registry, complete company name, and official address. This oversight led to a rejected submission during the OMS data review.

Our Solution

Our teams helped the client get back on track with OMS by rectifying supporting documentation and navigating resubmission. The client's subsequent exclusion from the system could have brought additional issues had there been ongoing clinical trial submission. Fortunately, the issue was resolved at an earlier stage.