Bundesamt für Sicherheit im Gesundheitswesen

www.basg.gv.at

Georg Neuwirther Head of IT Austrian Medicines and Medical Devices Agency

IDMP & SPOR @ AGES Gespräch 11/2017

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Motivation 1 Data-Exchange of Information about Medicinal Products in Europe (and worldwide)

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Motivation 2 Good data quality supports all processes in pharmacovigilance (and other

regulatory activities)

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Motivation 3 Cross-Border ePrescription

Source: EMA

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Enable an European product database

Support handling of shortages

Support processing recalls

..

..

Motivation 4 Further examples

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Issue 1: lack of standardisation

• Different controlled vocabularies* are

used across different NCAs

• Names used for organisations differ

between, and sometimes across

different departments within, NCAs

• Different names for products and

substances are used across different

NCAs

• Data is often entered manually

• Inconsistent data quality and duplication

• Inefficiencies relating to correcting data and

investigating data discrepancies

• Manual intervention required to resolve data

issues

• Slower decision-making

• Decision-making based on inaccurate

information

*Controlled vocabularies are

lists of terms that refer to

attributes of medicinal and

pharmaceutical products eg.

dosage form, route of

administration, unit of

measurement

Not an issue if you work separately but if you want

to collaborate with others

e.g. EudraPharm Vet, eMedikation, .. Source: EMA

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Similar information stored in several places

• e.g. organisations

• e.g. centralized products

Different formats, different ways of entering same information

Issue 2: No shared databases

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Legal Background

COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of

the Council and Directive 2001/83/EC of the European Parliament and of the Council

CHAPTER IV Use of terminology, formats and standards

Article 25 Use of internationally agreed terminology

1. For the classification, retrieval, presentation, risk-benefit evaluation and assessment, electronic exchange and communication of

pharmacovigilance and medicinal product information, Member States, marketing authorisation holders and the Agency shall apply

the following terminology …

EMA Website http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001849.jsp

“Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26) obliges European Union (EU) Member States,

marketing authorisation holders and EMA to make use of the ISO IDMP standards. This will impact on many areas of the

pharmaceutical regulatory environment, both in the EU and other regions. ”

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provide tools to share common information

Overview IDMP & SPOR

• standardise all relevant datafields

IDMP - Identification of Medicinal Products

SPOR – shared data for Substances, Products, Organisations, Referentials

• Provide shared repositories for substances, products,

organisations, referentials

• Provide controlled terms

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IDMP Identification of Medicinal Products

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ISO IDMP

• The ISO IDMP standards establish definitions and concepts and

describe data elements and their structural relationships that are

required for the unique identification of:

• Medicinal product information (MPID/PCID)

- ISO 11615

• Pharmaceutical product information (PHPID)

- ISO 11616

• Substances (Substance ID)

- ISO 11238

• Pharmaceutical dose forms, units of presentation,

routes of administration and packaging

- ISO 11239

• Units of measurement (UCUM) - ISO 11240

• ISO IDMP standards apply to both authorised and developmental

medicinal products for Human and Veterinary use

Source: EMA

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Standard 11615

ISO/TS 20443

• Health informatics -- Identification of medicinal products -- Implementation guidelines for ISO 11615

data elements and structures for the unique identification and exchange of regulated medicinal

product information

Standard 11616

ISO/TS 20451

• Health informatics -- Identification of medicinal products -- Implementation guidelines for ISO 11616

data elements and structures for the unique identification and exchange of regulated

pharmaceutical product information

Status standards and technical specifications

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Standard 11238

ISO/TS 19844:2016

• Health informatics -- Identification of medicinal products -- Implementation guidelines for data

elements and structures for the unique identification and exchange of regulated information on

substance

Status standards and technical specifications

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EU implementation Guideline

Status standards and technical specifications In progress

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IDMP Scope

Source: EMA - Introduction to ISO Identification of MedicinalProducts, SPOR programme

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Business

• Semantic descriptions (harmonised) of all relevant datafields

• e.g. reference strength

• Data formats, Controlled Terms usage

• Business rules

• Business Processes?

Technically

• Database models have to be refactored

• User interfaces must be updated

• Reporting could look different

• ….

IDMP consequences Impact on Business and IT

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Article 57

• XEVPRM, XEVMPD

• but no concrete plans currently available

ICSRs

“… as a consequence of the legal requirements set out in the legislation, the xEVPRM will be

replaced by the ISO IDMP format E2B(R3) …” (Source: Introduction to ISO Identification of MedicinalProducts, SPOR programme)

Further IDMP consequences

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IDMP will introduce a set of new IDs

IDs are needed for interoperability

and the business cases (e.g. PHV)

IDMP related IDs will be additional

to current IDs like authorization numbers

IDMP will introduces a set of new IDs

Medicinal Product

MPID

Medicinal

Product

Manufacturer

Marketing

Authorisation

Packaged

Medicinal Product

PCID

Pharmaceutical

Product

PhPID

Clinical

Particulars

Example Pharmaceutical Product

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MPIDs according to the standard could be to unstable for usage

• on MAH change

• on legal status of supply change

• on indications

PHPID (pharmaceutical product)

• There are several levels of pharmaceutical products a lot of IDs

a) Level 1: Substance(s)

b) Level 2: Substance(s) / Strength / Reference Strength

c) Level 3: Substance(s) / Administrable Dose Form

d) Level: Substance(s) / Strength / Reference Strength/ Administrable Dose Form

First impression

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SPOR

IDMP: set of standards and technical specifications defining the model of medicinal

products and substances

• no data; only documentation

SPOR: master data management

• SPOR-services will be provided and hosted by EMA

• contains and provides data

• based on IDMP standards

IDMP vs. SPOR

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1. Implement an integrated and harmonised master data management (MDM) solution which

will deliver standards compliant master data for Substances, Products, Organisations and

Referentials (SPOR).

2. Data will be collected, managed and made available to the network, industry and wider

stakeholder community, in compliance with legislative requirements and relevant standards

for privacy, data protection and security.

3. Implement a new portfolio of services which will be supported by standardised data

governance and lifecycle management.

4. Maximise the benefits realised throughout the Implementation f the roadmap by involving

and engaging effectively with stakeholders, leading to operating model simplification and

efficiency

Goals of SPOR Master data management MDM

Source: European Medicines Agency (EMA) Master Data Management Roadmap

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SPOR

Product Data

Referentials Common terminologies , building blocks

for product and substance data set .

Product European database of products for

human and veterinary medicines .

Substance

Single source of substance information

for the network .

Organisation Unique European identifier for

organisations e.g. Marketing

authorization holders , manufacturers

Source: EMA

online

online

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Substances – SMS

• active substances, excipients and adjuvant

• plan to build up an European Expert team

Substance are the core element for IDMP / pharmaceutical products and calculation of IDMP-IDs

To build a comprehensive list of substances in EU with a harmonised definition, supported by an

standardised data exchange model, available in an easily accessible format aimed to power business

and regulatory processes in EU and at global level. As adopted by EU ISO IDMP Task Force

12 June 2015

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Provides a medicinal product databbase set to support regulatory activities

for both human and veterinary domains - based on RMS, SMS and OMS

Products – PMS

This will be the core of our common European medicinal product database!

PMS - being more concrete … – NOT APROVED – only for illustration

Source: EMA website, EUNDB - – 19 February 2016 Georg Neuwirther 29

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Referentials - RMS

• Pharmaceutical forms

• Routes of

Administration

• Units of measure

• ATC codes

Examples

• EDQM

• EMA

• ISO

• WHO

• MSSO

Providers

To provide a single, trusted source of referentials data to be used across the EU Regulatory Network

and Pharmaceutical Industry, with consistent and well-understood mechanisms to update and

consume referentials lists

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We are used to that, aren’ we – EUTCT?

ONLINE: https://spor.ema.europa.eu/rmswi/#/

RMS

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RMS – Lists of controlled termin Currently 109 lists available

https://spor.ema.europa.eu/

Login needed (see also later)

Use Case: eAF!

RMS - requesting new terms or updates

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RMS / 3 Change Requests

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RMS - documentation

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Organisations – OMS

• Marketing Authorisation Holders

• Manufacturing sites

• Regulatory Authorities

• Applicants

• Clinical trial sites

Examples

To provide a consolidated source of high-quality and standardised organisation data to be used

across the EU Regulatory Network, that can support all regulatory activities.

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OMS – Organisation Management Service Scope

“Only” Names and Addresses – no yellow page

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OMS - basic concept for organizations

Org A Org B

Loc 3 Loc 2 Loc 1 Loc 4

Org_ID_A

Org_Loc_ID_1

Org_ID_B

Org_Loc_ID_4 Org_Loc_ID_2 Org_Loc_ID_3

Rules for unique organisations: • All location addresses in the same country • Organisation name is unique for all organisations in the same country.

DE UK

Note: Org A name can be the same as Org B name.

Source: EMA

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OMS

• Link: https://spor.ema.europa.eu/omswi/#/searchOrganisations

• No login needed!

OMS – Roll Out

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Source: EMA, https://spor.ema.europa.eu/omswi/#/viewDocuments, RMS and OMS - Industry on-boarding to SPOR

https://spor.ema.europa.eu/omswi/#/viewDocuments

OMS – Documentation

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RMS & OMS

User Credentials

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OMS & RMS User Registration

Source: EMA, https://spor.ema.europa.eu/omswi/#/viewDocuments, RMS and OMS - Industry on-boarding to SPOR

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OMS & RMS User Roles

Source: EMA, https://spor.ema.europa.eu/omswi/#/viewDocuments, RMS and OMS - Industry on-boarding to SPOR

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OMS & RMS Super User

very similar to our eServices

Admin can mantain further userss

Source: EMA, RMS and OMS - Industry on-boarding to SPOR

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OMS & RMS Handling multiple organisations

Georg Neuwirther 46 Source: EMA, RMS and OMS - Industry on-boarding to SPOR

OMS & RMS Even complex scenarios should be possible

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Source: EMA, RMS and OMS - Industry on-boarding to SPOR

OMS & RMS 1st super user

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OMS & RMS Registration Systems required for

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servicedesk.ema.europa.eu

EMA‘s service desk for issues, registrations, tickets, etc.

https://register.ema.europa.eu/identityiq/login.jsf

Login to SPOR

OMS & RMS Registration 1st Super User verification

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Source: EMA, RMS and OMS - Industry on-boarding to SPOR

OMS & RMS Registration 1st Super User verification

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Source: EMA, RMS and OMS - Industry on-boarding to SPOR

OMS & RMS Registration 1st Super User verification

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Source: EMA, RMS and OMS - Industry on-boarding to SPOR

OMS & RMS Registration Documentation

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Source: EMA, RMS and OMS - Industry on-boarding to SPOR

OMS & RMS SLAs

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Source: EMA, RMS and OMS - Industry on-boarding to SPOR

RMS & OMS Milestones

Georg Neuwirther 55 Source: EMA, RMS and OMS - Industry on-boarding to SPOR

Source: EMA, RMS and OMS - Industry on-boarding to SPOR

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Register Super Users (from December)

Get familiar with RMS controlled terms

• Check your RIMs for compatibility – consider mapping

• Request new terms or updates if needed

Check your OMS data once available

Check EMA and BASG website for further

information

• Especially for PMS and SMS plans

Attend EMA webinars and AGES Gespräche!

• Get in contact with your associations

Register at the SME office for newsletter

• Link

Take home messages SPOR

Source: EMA, RMS and OMS - Industry on-boarding to SPOR

BASG -

Austrian Federal Office for Safety in Health Care

www.basg.gv.at

Traisengasse 5

1200 Vienna

Head of IT Austrian Medicines and Medical Devices Agency

georg.neuwirther@basg.gv.at

georg.neuwirther@ages.at

Georg Neuwirther

Bundesamt für Sicherheit im Gesundheitswesen

www.basg.gv.at