IDMP Wiki

GINAS

Global Ingredients Archiving System (GINAS)

What is GINAS in relation to ISO 11238

GINAS and ISO 11238 specifically addresses the identification and exchange of regulated information on substances.  GINAS supports all substance types described in the 11238 standard and provide multiple language capability for the naming of substances and controlled terminology used within the IDMP.

Background of GINAS

Globalisation presents tremendous challenges and opportunities for national regulatory agencies, the pharmaceutical industry, and global health as a whole. Emerging diseases and the health impacts of catastrophic events respect no national boundaries, nor does the increasing volume of substandard, contaminated, and counterfeit products that overburdens national regulators. Ingredients for pharmaceutical products are typically sourced on a global basis and it is very rare that all ingredients for a single product are produced within one jurisdiction. To regulate the global supply chain efficiently and to better respond to and prepare for catastrophic events it is essential to have a global information system for pharmaceutical ingredients.

ISO 11238 specifically addresses the identification and exchange of regulated information on substances. Working closely with that standard’s authors and regulatory authorities from various countries, NCATS is developing an information system to register and store substance-related information and provide identifiers. This will ensure a robust substance registration system that supports the additional needs of national and regional authorities and is consistent with the ISO 11238 standard. The system will support all substance types described in the 11238 standard and provide multiple language capability for the naming of substances and controlled terminology used within the system.

GINAS Project Description

The Global Ingredient Archival System (GINAS) represents a major opportunity for regulators worldwide to tackle the challenges of sharing ingredient information. This tool makes it possible to create a global standard for defining substances and a common identifier to identify ingredients in medicinal products. This will enable the global health community to share and use information to significantly improve health care delivery, the proper use of medications, and the management of risks involved in their use.

The project’s main goal is to provide a consistent definition of substances globally, and a common identifier for all the substances used in marketed medicinal products as well as active substances under clinical investigation. It is envisioned that a consortium of regulators from different national and international agencies would operate and maintain the platform in a secure and trusted manner. This centralized database will result in higher quality data while still respecting confidentiality requirements.

The software tools used in this project are developed, maintained, and distributed to project members and other interested parties by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). As well as containing definitional information and identifiers, the system is able to store a wide variety of structured information on the identification, analysis, use, manufacture, pharmacology, and toxicology of medical product substances.

Goal of the Program

GINAS is a solution to the costly, duplicative, and piecemeal approaches currently being used. It will enable regulators to more easily monitor the global marketplace. The system could play a vital role in facilitating a global approach to pharmacovigilance; identifying and tracking substandard products and ingredients; alleviating drug shortages; enhancing clinical development; and coordinating and streamlining regulatory actions worldwide. The project will benefit industry by offering a “one-stop shop” to deposit substance-related regulatory information. It will help in developing specifications of substances and products in a more consistent manner, and in coordinating facility inspections. Finally, the project should dramatically reduce the time and costs of information-gathering for both companies and regulators.
NCATS intends this software product to be a freely distributable, maximally self-contained system to register substances and related manufacturing, analytical, and relevant biological information on substances that are of interest to health product regulators, product sponsors, and health researchers. Consistency will be achieved through a common data model and synchronization with a central database.
Since February 2013, Canadian, Dutch, German, Swiss, and U.S. regulators have been working with NCATS to create this system. Health Canada is providing an environment for collaborative development. This environment  supports the initial curation and mapping of content used for global substance identification.
The project group welcomes participation and sponsorship by regulatory agencies and other public health organizations throughout the world. It aims to be a global resource that will benefit public health by facilitating the transfer of regulatory information and providing industry and other interested stakeholders with a uniform process for depositing substance-related information.

IDMP Wiki

IDMP

IDMP Definition of Identification of Medicinal Products

IDMP defines the data elements and structures for the unique identification and exchange of medicinal products´ information.

Download here for free the “What is IDMP” PDF File

Iso IDMP Standards at a glance

IDMP Standards - What is IDMP?

ISO IDMP Standards

The set of fife ISO international standards has been developed by the ISO in response to a worldwide demand for internationally harmonised specifications for identification and description of medicinal products.

Article 40 of the new pharmacovigilance implementing measures legislation mandated the EMA to use the ISO IDMP standard latest by July 2016.

IDMP provides the basis for the unique identification of medicinal products, which facilitates the activities of medicines regulatory agencies worldwide by jurisdiction for a variety of regulatory activities (development, registration and life cycle management of medicinal products, pharmacovigilance, and risk management). They can also be applied to Investigational Medicinal Products.

Messaging specifications are included as an integral part of the IDMP Standards. They describe and protect the integrity of the interactions for the submission of regulated medicinal product information in the context of the unique product identification; they include acknowledgement of receipt including the validation of transmitted information. Health Level Seven (HL7) Message Exchange are normative within the IDMP Standards.

IDMP Standards are completed with Implementation Guides which are currently in development (2015), as well as with Technical Specifications (TS) 16791 (provides guidance for the identification of medicinal products by using intenational supply chain Standards, securing traceability, safe supply chain and other market requirements) and Technical Requirements (TR) 14872 (Requirements for the implementation of the Standards for the identification of medicinal products for the exchange of regulated medicinal product Information), the latter being in development.

Implications for Marketing Authorisation Holders (MAHs)

In order to submit the data all branches of a company should share a common language, from pharmacovigilance to product supply to comply with the controlled vocabulary dedicated.
The structured substance information, and controlled vocabularies for pharmaceutical dose forms, units of presentation, routes of administration, and packaging will be challenging to integrate.
Furthermore the terminology needs to be aligned throughout the company.

You will find more details here

IDMP Wiki

SPOR

SPOR

(as of 23.03.2018, Ursula Tschorn, IDMP SPOR Industry Change Liaison)

SPOR is short for Substances Products Organisations and Referentials in the IDMP projects of the EMA. SPOR data services will act as the vehicle for implementation of ISO IDMP standards in the regulatory and the e-health world.

SPOR data services

SPOR is aimed at delivering quality data services on Substances, Products, Organisations and Referentials to power EU regulatory activities.

Four projects have been established

Four projects have been established at the EMA to implement services that centralise management of each of the domains of master data. The four projects are collectively known as SPOR data services and the single once are abbreviated with SMS, PMS, OMS and RMS.

SPOR Data Services

SPOR Data Services

Implementation of the four projects

The implementation of the four projects will be phased.

  • All proposals relating to implementation of the projects on Substances, Products, Organisation and Referentials have been and will continue to be consulted on widely with regulators and industry representatives.
  • IDMP with its referentials applies to both domains, Human and Veterinary
  • In parallel, EMA is implementing the messaging standards developed by Health Level Seven (HL7), which define a format for the electronic exchange of data that is compliant with the ISO IDMP technical specifications.

Use of SPOR in regulatory activities

Adoption of IDMP operating models will facilitate the implementation of consistent, centrally-maintained, ISO IDMP-compliant data, which will feed regulatory activity across the product lifecycle.

Benefits

Standardised data alone is not sufficient to achieve benefits. The benefits will be realised incrementally:

  • As all phases of SPOR are completed; and
  • Provided other opportunities for integration are implemented via EU Telematics Programmes such as CESSP, Clinical Trials EU Portal

New ways of accessing SPOR data

There are 4 ways of accessing the SPOR data:

  • web interface
  • APIs* (Application Programming Interface)
  • Draft API specifications have been shared with SPOR Task Force; final API specifications are expected to be published in August
  • For RMS, backward compatibility will be maintained with EUTCT for NCAs who use EUTCT
*An API is a mechanism to allow your IT systems to exchange information automatically with RMS and OMS

Download SPOR API Documentation
(Udated 9.1.2018)

A new edition (version 1.14 published 09.01.2018) of the SPOR API documentation (API schemas, OMS & RMS message formats and HL7) is accessible for interested parties for a free download in this website:

The latest version of the API specification incorporates the following additional information:

  • A description of how an implementing system must retain rowid elements in the creation, and later management, of change requests in RMS.
  • A description on the fields that have to be conditionally provided when dealing with both OMS and RMS change requests depending on the status and the data of such requests.
  • An explanation on how OMS retains compatibility for searching elements based on identifiers, even after they have been merged, and how the current identifier, of an element, is highlighted in the response data.
  • A description on what kind of change requests can be filed in OMS depending on the status of the referred organisation and/or location.
The API specification covers both RMS and OMS. This has been taken through consultation during April to July 2016 and the feedback has been incorporated in the specification (consultation is now closed).
wiki spor documentation

Please note that in the SPOR API specification, the services are set out in Section 6 and those that are OMS-specific are marked “O”, RMS-specific are marked “R”, and services shared by both RMS and OMS are marked as  “RO”.

The documents have been shared with the SPOR Task Force and UAT testers.

EMA Data Stewards

EMA will take over the function of a data steward to maintain and coordinate the SPOR data.

  • A specialised team of EMA staff that will manage data on behalf of stakeholders and provide user support
  • Validate access requests to SPOR services
  • Directly involved in maintaining the quality of the data:
    Profiling the data (assessing quality of data)
    Various data anomalies (different formats of the data e.g. telephone number) can be identified / monitored and data correction can be initiated
    Reports generated using this cleansed data will be more reliable
  • Take action on change requests for new/amended Referential Lists/Terms and Organisation data

Data content

RMS lists at go-live:

  • Lists from EUTCT (apart from Substance list)
  • Lists to support OMS
  • Lists for ISO 11239 (Pharmaceutical dose forms, units of presentation, routes of administration and packaging) and ISO 11240 (Units of measurement)
  • Some lists to support  PMS project (e.g. Material)

Content of the OMS dictionary at go live:

  • MAHs: (H+V) CAPs & (H) NAPs
  • MAAs: (H+V) CAPs
  • MRL applicants (Vet)
  • MA & MRL contacts: (H+V) CAPs

 

Referentials Management Services RMS Operating Model

wiki spor rms process in regulatory context

 

 

Organisations Management Services OMS Operating Model

SPOR Organisation Operating Model

 

Key Industry engagement activities

  • Industry is now asked to start with mapping activities from their local data to IDMP SPOR referentials
  • Industry Change Liaisons will provide a continuous channel for information and training throughout the year
  • In addition, a number of specific events are planned that will be open to all Industry stakeholders

In summary

  • SPOR data services will act as the vehicle for implementation of ISO IDMP standards
  • SPOR data services will enable the realisation of benefits at all stages of the product lifecycle due to future integration of regulatory processes with SPOR’s standardised data and central data management services
  • Implementation of RMS and OMS is the first step in a phased approach to roll-out of SPOR and of other Programmes dependent on SPOR data
  • In order to be ready for the future changes brought about by IDMP and by integration with other Programmes, Industry should prepare now to ensure they have the foundations in place through alignment with RMS and OMS

Webinar Implementing ISO IDMP: introduction to SPOR data services

Link to EMA´s Information on Substances, Products, Organisations and Referentials