Regulatory Operations: Data Management

Offers a full range of services to provide a comprehensive support for data compliance for: Human medicines, Veterinary medicines and Medical devices.

Being a reference point for xEVMPD services, we are fully ready to support companies with: ISO IDMP, RIMS and DMS implementation.

Regulatory Operations: Data Management

Asphalion offers a full range of services to provide a comprehensive support for data compliance for:

  • Human medicines
  • Veterinary medicines
  • Medical devices

Being a reference point  for xEVMPD services, we are fully ready to support companies with:

  • ISO IDMP implementation
  • Regulatory Information Management System (RIMS) implementation
  • Document Management System  (DMS) implementation

 

Data Management Unit Services

 

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the unique Identification of Medicinal Products, thus called “ISO IDMP”.

The main purpose of ISO IDMP is to allow the standardization of data both for authorised and investigational medicinal products for human use and veterinary products.

The five ISO IDMP standards establish the definitions and concepts that describe the data elements and their structural relationships. This enables the unique identification of:

  • Medicinal product information (MPID/PCID) – ISO 11615
  • Pharmaceutical product information (PhPID) – ISO 11616
  • Substances (Substance ID/Specified Substance ID) – ISO 11238
  • Pharmaceutical dose forms, units of presentation, routes of administration and packaging – ISO 11239
  • Units of measurement (UCUM) – ISO 11240

 


 

EMA is implementing ISO IDMP trough a phased programme called SPOR that is based on these 5 ISO standards.

SPOR comes from:

  • Substance: Harmonised data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product.
  • Product: Harmonised data and definitions to uniquely identify medicinal product based on regulated information (e.g., marketing authorisation, packaging and medicinal information).
  • Organizations: Data that comprises organisation name and location, address data for organisations, such as MAH, sponsors, regulatory authority, manufacturers.
  • Referentials: Lists of terms (controlled vocabularies) used to describe attributes of products, e.g., lists of dosage forms, units of measurement and routes of administration.

There is a legal obligation for the industry to make use of the terminologies defined in ISO IDMP standards, as stated in Regulation (EU) No 520/12012 (art. 25 & 26).

SPOR is an ISO IDMP compliant business service that allows the central management of data based on four main services: SMS-Substance Management Service, PMS-Product Management Service, OMS- Organizations Management Service and RMS- Referentials Management Service. SPOR applies to both areas, human and veterinary.

Its purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.

 


 

The introduction and progressive implementation of new IDMP standards means that organizations will need to capture and manage significantly more regulatory data than ever before, which represents a significant challenge to the industry as a whole.

Effective data management involves significant effort, is time-consuming and costly.

Every stakeholder in the pharmaceutical sector is creating and manipulating data: Industry, Agencies, MAHs and other Organizations. Data is an asset, unless is not organized, understandable and accessible. Inconsistent, disorganized and non-accessible data only causes delays, increased costs and process difficulties, among others.

SPOR is expected to improve not only how data is created, manipulated and maintained but, ultimately, how other stakeholders can use it for the improvement of regulatory activities, pharmacovigilance, inspections and other, such as shortages, falsified medicines directive, prescription, etc.

Organizations need to capture and manage significantly more data than ever before, which represents a significant challenge to the industry as a whole. Furthermore, they need to adjust their data governance processes, which involves significant effort, is costly and time-consuming.

Asphalion offers a full range of services to provide a comprehensive support for data compliance for:

  • Human medicines
  • Veterinary medicines
  • Medical devices

Being a reference point  for xEVMPD services, we are fully ready to support companies with:

  • ISO IDMP implementation
  • Regulatory Information Management System (RIMS) implementation
  • Document Management System  (DMS) implementation

 

Data Management Unit Services

 

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the unique Identification of Medicinal Products, thus called “ISO IDMP”.

The main purpose of ISO IDMP is to allow the standardization of data both for authorised and investigational medicinal products for human use and veterinary products.

The five ISO IDMP standards establish the definitions and concepts that describe the data elements and their structural relationships. This enables the unique identification of:

  • Medicinal product information (MPID/PCID) – ISO 11615
  • Pharmaceutical product information (PhPID) – ISO 11616
  • Substances (Substance ID/Specified Substance ID) – ISO 11238
  • Pharmaceutical dose forms, units of presentation, routes of administration and packaging – ISO 11239
  • Units of measurement (UCUM) – ISO 11240

 


 

EMA is implementing ISO IDMP trough a phased programme called SPOR that is based on these 5 ISO standards.

SPOR comes from:

  • Substance: Harmonised data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product.
  • Product: Harmonised data and definitions to uniquely identify medicinal product based on regulated information (e.g., marketing authorisation, packaging and medicinal information).
  • Organizations: Data that comprises organisation name and location, address data for organisations, such as MAH, sponsors, regulatory authority, manufacturers.
  • Referentials: Lists of terms (controlled vocabularies) used to describe attributes of products, e.g., lists of dosage forms, units of measurement and routes of administration.

There is a legal obligation for the industry to make use of the terminologies defined in ISO IDMP standards, as stated in Regulation (EU) No 520/12012 (art. 25 & 26).

SPOR is an ISO IDMP compliant business service that allows the central management of data based on four main services: SMS-Substance Management Service, PMS-Product Management Service, OMS- Organizations Management Service and RMS- Referentials Management Service. SPOR applies to both areas, human and veterinary.

Its purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.

 


 

The introduction and progressive implementation of new IDMP standards means that organizations will need to capture and manage significantly more regulatory data than ever before, which represents a significant challenge to the industry as a whole.

Effective data management involves significant effort, is time-consuming and costly.

Every stakeholder in the pharmaceutical sector is creating and manipulating data: Industry, Agencies, MAHs and other Organizations. Data is an asset, unless is not organized, understandable and accessible. Inconsistent, disorganized and non-accessible data only causes delays, increased costs and process difficulties, among others.

SPOR is expected to improve not only how data is created, manipulated and maintained but, ultimately, how other stakeholders can use it for the improvement of regulatory activities, pharmacovigilance, inspections and other, such as shortages, falsified medicines directive, prescription, etc.

Organizations need to capture and manage significantly more data than ever before, which represents a significant challenge to the industry as a whole. Furthermore, they need to adjust their data governance processes, which involves significant effort, is costly and time-consuming.

Regulatory Operations: Data Management Solutions

At Asphalion we can give you support and help you navigate through the awareness process and work with you to be ISO IDMP compliant whether you have, need or can’t yet access a RIM system.

  • xEVMPD is the Extended Eudravigilance Medicinal Product Dictionary of the European Medicines Agency (EMA). It provides a standardized vocabulary for the Marketing Authorization of medicinal products.
  • Supporting xEVMPD submissions from the inception of the obligation, since July 1st, 2012.
  • Managing an average of 3500 xEVMPD petitions per year

 

Importance of 3rd Acknowledgement management in the context of data migration to PMS

⚠️ Managing EMA’s 3rd ACK is a crucial step in the context of migrating xEVMPD data into PMS, aimed at preventing and minimizing inconsistent data input into both the PMS database and eAF.

What is ISO IDMP?

  • The ISO IDMP standards specify the use of standardized definitions for identifying and describing medicinal products for human use.
  • Their purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.
  • They help to ensure wide interoperability across global regulatory and healthcare communities, which is critical in ensuring accurate analysis and unambiguous communication across jurisdictions.
  • The Commission Implementing Regulation (EU) mandates European Union Member States, Marketing Authorization Holders, and the EMA to adhere to the ISO IDMP standards. This requirement will have a significant impact on various aspects of the pharmaceutical regulatory environment, both within the EU and in other regions.
  • ISO IDMP encompasses the entire lifecycle of medicinal products, including those in development, investigational stages, under evaluation, and already authorized. It offers a more comprehensive and detailed approach compared to xEVMPD and is expected to be implemented starting from 2025 onwards.

 

How to implement ISO IDMP

 

ISO IDMP Implementation

 

If you need further information or wish to explore how we can assist you during this transition:
Contact us!

 

Why choose ASPHALION for ISO IDMP implementation

  • Regulatory Expertise: Asphalion’s team has specialized knowledge in regulatory affairs, ensuring ISO IDMP compliance with current regulations.
  • Custom Implementation: We offer tailored strategies to meet the unique needs and challenges of each client’s product portfolio.
  • Technology Integration: Asphalion excels in integrating IDMP solutions with clients’ current systems, guaranteeing a smooth transition.
  • Proven Success: Asphalion has a demonstrated history of successful ISO IDMP implementations, supported by client testimonials and case studies.

 

If you need further information or wish to explore how we can assist you during this transition:
Contact us!

What is a RIMS?

  • A Regulatory Information Management System (RIMS) facilitates the submission of both human and veterinary medicinal products to regulatory agencies for marketing authorization.
  • This invaluable software system aids in managing product dossiers and regulatory data, preparing submissions, and maintaining regulatory product information in the required formats.
  • Despite the widespread adoption of RIMS by pharmaceutical companies, many still rely on manual data entry. In the current landscape, it´s imperative for RIMS to be capable of directly transmitting data to the EMA.
  • Companies are now required to gather a larger volume of data at earlier stages, necessitating robust technological solutions to meet these demands.

 

What should an effective RIMS look like?

  • Enables to quickly and accurately identify product information requested by regulatory agencies
  • Collects product information under the eCTD specification
  • Takes into account the variation of products in the different agencies when creating a record
  • Correctly manages file changes and revisions, as well as product updates
  • Generates documentation subject to be submitted according to standards
  • Tracks all presentations and publications
  • Reduces times to issue submission to Regulatory agencies
  • Allows a clear monitoring from original submission during product life cycle
  • Adapts to company needs in terms of data volume and size to be managed
  • Complies with Regulatory requirements

 

Request a demo!

 

Partners

RIMS implementation partners

 

WHY to choose Asphalion for migration activities during RIMS implementation

  • Regulatory Information Expertise: Asphalion possesses deep expertise in managing regulatory information, ensuring that RIMS implementation aligns with global regulatory standards.
  • Streamlined Data Management: Our company provides solutions that streamline the management of regulatory data across the product lifecycle, enhancing efficiency and accuracy.
  • Customized Integration: Asphalion tailors RIMS integration to client-specific systems and processes, facilitating a smooth incorporation with minimal operational disruption.
  • Compliance Assurance: With a strong focus on compliance, Asphalion collaborates with vendors to ensures that the RIMS implementation meets all regional and international regulatory requirements.
  • Technology Leadership: Asphalion stays at the forefront of technological advancements, offering clients cutting-edge RIMS solutions that provide a competitive advantage

 

If you need further information or wish to explore how we can assist you during this transition:
Contact us!

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Why Asphalion?

xEVMPD Compliance

  • Over 10 years of experience since the inception of the Art. 57 obligation
  • We offer comprenhensive services, including bulk updates and products exports

RIMS Implementation Expertise

  • Diverse expertise in human and animal health products, including innovative, OTC and generics.

Leading ISO IDMP Transition

  • Our dedicated team ensures a smooth transition to ISO IDMP
  • Direct engagement with EMA, contributing to the EU Implementation Guide.
  • We provide end-to-end support, from initial awareness to hands-on data management.
Silvia Santos - Asphalion
Silvia Santos
Data Management Associate Director
“Asphalion is committed to offering specialized knowledge in transition to ISO IDMP, RIMS implementation, and PMS verification”

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