idmp / spor essentials · Österreichische agentur für gesundheit und ernährungssicherheit gmbh...

Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH www.ages.at

IDMP / SPOR essentials

Georg Neuwirther

29/11/2016, AGES Gespräch

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It’s all about …

Standardization and digital collaboration in the EU and worldwide (EU, US, JP, …)

Experiences / lessons learned

• Documentation: CTD, eCTD, NeeS, VNeeS, ..

• Terms: EUTCT, MedDRA, EDQM, WHO, ..

• Messaging: XEVMPr, ICSR, EudraCT-XML, ..

2 Georg Neuwirther, AGES-Gespräch - 29/11/2016

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e.g.

MAH, product details

Why do we request the same data again and again ….


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Need for standardisation?


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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_000645.jsp

Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26) obliges Member States, marketing-authorisation holders and EMA to make use of the terminologies defined in ISO IDMP standards from July 2016. ”

“ 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. The format is based on the existing HL7 standard, the Common Product Model.”

Source:


http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000645.jsp

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000645.jsp

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:159:0005:0025:EN:PDF

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:159:0005:0025:EN:PDF

http://www.hl7.org/

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Industry EU Regulatory Network

International Standards &

Terminology

• Marketing Authorisation Holders (MAH) CAPS

• Marketing Authorisation Holders (MAH) NAPS

• Marketing Authorisation Applicants (MAA)

• Small and medium-sized enterprises (SMEs)

• Clinical Trial Sponsors (and other CT roles)

• European Federation of Pharmaceutical

Industries and Associations (EFPIA)

• European Biopharmaceuticals Enterprise (EBE)

• European Federation of Statisticians in the

Pharmaceuticals Industry (EFSPI)

• European Generic Medicines Association (EGA)

• European Confederation of Pharmaceutical

Entrepreneurs (EUCOPE)

• European CRO Federation (EUCROF)

• EuropaBio

• Qualified Persons for Pharmacovigilance (QPPV)

• International Federation for Animal Health –

Europe (IFAH-Europe)

• European Group for Generic Veterinary Products

(EGGVP)

• Vaccines Europe (VE)

• Eye Care Industries European Economic Interest

Grouping (ECI – EEIG)

• Association of the European Self-Medication

Industry (AESGP)

• The Association of Veterinary Consultants (AVC)

• European Commission (EC)

• Large National Competent Authorities (NCA-L)

• Medium National Competent Authorities (NCA-M)

• Small National Competent Authorities (NCA-S)

• Veterinary National Competent Authorities only

(NCA-Vet)

• CxMPs / groups (CMDh)

• CVMP / CMDv

• World Health Organisation (WHO)

• WHO Uppsala Monitoring Centre (WHO-UMC)

• European Directorate for the Quality of Medicines

(EDQM)

• MeDRA Maintenance and Support Services

Organisation (MSSO)

• EMA Management Board (EMA MB) (Strategic )

• Heads of Medicines Agency (HMA) (Strategic )

• European Telematics Management Board (EU

TMB) (Strategic)

• EU Network Data Board (EU NDB) (Tactical)

• IT Directors Group (Tactical)

• Telematics Enterprise Architecture Board

(Tactical)

• SPOR Task Force (Operational)

Key International Regulators

• Food and Drugs Administration (FDA)

• Swissmedic

EU Network Governance / Group

Stakeholder


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SME information

Source: EMA – Introduction to SPOR Data Services 04/08/2016

The email address that is published on the EMA web site is [email protected] http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000061.jsp&mid=WC0b01ac0580024b96


mailto:[email protected]

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000061.jsp&mid=WC0b01ac0580024b96

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Theory, Standards, Documentation Daily Life, Re-Use of Data

IDMP-Standards SPOR- common data repositories

Measures to improve the situation …



IDMP

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ISO IDMP – What it is

Source: EMA


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ISO IDMP – What it is

• 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 - ISO 11615 • Pharmaceutical product information - ISO 11616 • Substances - 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 use


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ISO IDMP – Components

Medicinal Product

Medicinal Product

Manufacturer

Marketing Authorisation

Packaged Medicinal Product

Pharmaceutical Product

Clinical Particulars


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An example: Medicinal product

• Standardisation of semantics • e.g. invented name, full name will be described

• Standardisation of relations between data fields • e.g one medicinal produces consists of 1 or more pharmaceutical products

• Standardisation of data formats and restrictions • e.g. datafield “A” is based on controlled terms like “pharmaceutical form”

• e.g. format rules digits only, etc.


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Additional identifiers in IDMP

• IDMP introduces a set of new IDs like

- MPID – Medicinal product ID

- PCID – Package ID

- PhPID - Pharmaceutical product ID

• These IDs are additional to current IDs like authorization/approval numbers

• These IDs will be the key for interoberability in pre-marketing, authorisation, post-marketing, eHealth, …


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Article 57 database component

Medicinal Product A –

MPID 1 MAH 1

Medicinal Product B

MPID 2 MAH 2

This „neutralisation“ of data is the key for future post-authorisation processes!

Pharmaceutical Product 1 PhPID 10 Substance 1l 100mg Tablet

Linking things together


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Impacts for Industry

Your data should be compatible with IDMP standards.

Analyse your database-models

Analyse your data content

“Adapt” your database model to IDMP there are several ways to achieve this

Migrate data to new granularities, controlled terms there are several ways to achieve this

bring colleagues together from regulatory affairs, pharmacovigilance, IT, …



SPOR

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Goals of SPOR before Master data management MDM

1. Implement an integrated and harmonised 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 of the roadmap by involving and engaging effectively with stakeholders, leading to operating model simplification and efficiency

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


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Where will SPOR be used? Source: EMA – Introduction to SPOR Data Services 04/08/2016


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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


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Referentials – What Are They ?

• Pharmaceutical forms • Routes of Administration • Units of measure • ATC codes

Examples

• EDQM • EMA • ISO • WHO • MSSO

Providers

Broker service will be provided by EMA

Source: EMA


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Substances – What Are They ?

• Substances active, excipients and adjuvant

• Multiple sources

• Plan to use Global Substance Registration System (GInAS)


Source: EMA


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Organisations – What are they?

• Marketing Authorisation Holders

• Manufacturing sites • Regulatory Authorities • Applicants • Clinical trial sites

Examples


Source: EMA


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OMS – scope / out of scope

• OMS contains organisations and individuals

- e.g. Search for all companies starting with Ba* in Vienna

• Individuals are not available for NCAs via OMS

- due to privacy restrictions – under investigation at EMA

• OMS doesn’t contain contextual information like roles and eligibilities

- E.g. out scope: “return a list of all manufacturers in EU”

- Will be in PMS


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Basic concept for organizations in OMS

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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Stepwise approach in OMS Source: EMA – Introduction to SPOR Data Services 04/08/2016


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Phase I - Organisations Operating Model – Implemented as part of the first OMS project

NC

AEM

AIn

du

stry

Scenario applicable when the regulatory submission takes place with an NCA

Submit application

Message containing:

<EU_Loc_ID>

<Organisation data>

<Other IDs>

etc.

If not registered, assign

NCA_org_ID and validate

against EU_Loc_ID

MDM (EU Hub)

Publish data in the

organisation dictionary

Request

Organisation

registration or

update

EU_Loc_ID and organisation data (& other IDs)

EU_Loc_ID and

organisation data (&

other IDs)

NCA_org_ID &

EU_Loc_ID and

organisation data

(& other IDs)

Request for

organisation

registration or

update

Pre-Registration of Organisation in the EU

Organisation Hub

Request for

organisation

registration or

update

Applications/information sent as part of regulatory activities

Register and issue

EU_Loc_ID & Org_ID

Phase I OMS Operating Model Source: EMA


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Fahrplan Source: EMA – Introduction to SPOR Data Services 04/08/2016

1.

2.

3.

4.

IG not yet

published!!! 28 Georg Neuwirther, AGES-Gespräch - 29/11/2016

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Implementation of new data operating models for each domain of

master data. Pre-registration of new Organisations is required in

OMS operating model

The need for NCAs and Industry to transform or restructure1, enrich2 and map data3 locally

To enable these changes, EMA, NCAs and Industry will need to adapt their own systems and processes eg. new process for maintaining synchronicity of local source systems with central SPOR data

New solutions for access and use of central SPOR data.

SPOR will bring about key changes

1 Data may need to be transformed to a structured format eg. captured

in data fields in an Access database vs included in a pdf

2 Data may need to be enriched ie. additional data fields to provide

a complete set of data in line with ISO data requirements

3 Data mapping is the process of matching data elements between two

(or more) distinct sets of data Source: EMA Adapted by AGES MEA


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Checklist Industry (RMS/OMS) Source: EMA – Introduction to SPOR Data Services 04/08/2016

Prepare

Map

Sychronise

Pre-Register

Map and observe

Sychronise


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Please contact me for further questions: [email protected]


mailto:[email protected]

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