Product Management Services & Substance Management Services (P&SMS) Projects - Implementation of ISO IDMP standards through SPOR master data
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Product Management Services &
Substance Management Services
(P&SMS) Projects
Implementation of ISO IDMP standards through SPOR
master data
An agency of the European Union
© EMA 2016
Topics
1. 2. 3.
Implementation SPOR in the
Background
of IDMP through regulatory
SPOR context
• SPOR vs IDMP • Past • SPOR in the
• What will SPOR • Next Steps regulatory context
deliver • EU Guidance • SPOR integration
• Future with eAF
• Data Migration • SPOR as an
Strategy enabler of process
changes
1
© EMA 20161. Background
An agency of the European Union
© EMA 2016SPOR vs IDMP
• ISO IDMP standards (five standards) define the rules that uniquely identify
medicinal product and the relevant elements to identify them
• 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.
• The SPOR projects implements the ISO IDMP standards as well as the processes
to manage four domains of data (master data) in pharmaceutical / regulatory
industry:
• Substance Management Services (SMS) – ISO 11238
• Product Management Services (PMS) – ISO 11615, 11616
• Organisation Management Services (OMS)
• Referentials Management Services (RMS) – ISO 11239, 11240
• Delivery of SPOR is phased
• RMS and OMS services were delivered in June 2017
• Delivery of PMS and SMS will follow
• P&SMS Iteration 1 covers authorised human & veterinary medicinal products
• P&SMS Iteration 2 covers Investigational medicinal products.
• P&SMS Iteration 3 covers Clinical Particulars.
• SPOR applies to both domains Human & Veterinary
3
© EMA 2016What will SPOR deliver?
SPOR data is accessible via New process for industry
a web User Interface and NCAs to pre-
(UI) and SPOR APIs* register/update SPOR
(Application Programming data before submitting
Interface) regulatory applications.
Data is entered once and
reused in different
.
A specialised team
processes.
of EMA data
stewards will manage
SPOR data
and provide support to
stakeholders
.
List of organisations
New data management approaches for (OMS dictionary),
industry, NCAs and the EMA: Referentials Lists/Terms
- Data synchronisation on an ongoing and Substances for
basis stakeholders to use in EU
- Possible need for data regulatory activities
4
transformation/enrichment © EMA 20162. Implementation of IDMP
through SPOR data management
services
An agency of the European Union
© EMA 2016A. Past
6
© EMA 2016The road behind (2015-2017) – SPOR Achievements
Feb 2015: Selection of
the technology to support June 2017: RMS went live and replaced
SPOR implementation. EUTCT as preferred source of regulatory
referential data.
Mar 2015:
SPOR Roadmap
agreed. June 2017: OMS went live and manages
regulatory organisation data. NCA content
Mar 2015: is available. Industry content expanded
SPOR TF set up. throughout 2017-2018.
May 2015: Q1- Q2 2017:
RMS project started. June 2017: NCA P&SMS project
users on-boarding started.
Mar 2016: Dec 2017: Industry
July 2015:
Change Liaison user on-boarding.
Green light form HMA for June 2017:
Network set up.
RMS & OMS Target Initial schedule for
Operating Model (TOM) . P&SMS communicated
Jul 2016: to SPOR Task Force
Jul 2015: Technology Veterinary Stakeholders
purchase. join the SPOR Task
Force (TF).
Jul 2015:
OMS project started.
Q1 2015: SPOR Q2 2015: First 2015-2016: Engaging
June 2017: RMS 2017: Users start using
strategy and approach two SPOR projects with Industry and
implements ISO11239 SPOR Target Operating
agreed with Industry, ongoing. regulators through SPOR
and ISO11240 Model for pre-registration
Regulators and EC. TF and cascading
standards; makes EMA of master data to improve
communications through
regulatory compliant. regulatory submissions.
Change Liaison network.
7 © EMA 2016
7SPOR Data Management Services portal
http://spor.ema.europa.eu/sporwi/
SPOR portal is compatible with web browsers Internet Explorer (version 10 and above) and Chrome (version 58 and above)
8
© EMA 2016B. The next steps
9
© EMA 2016The next steps (2017-2018) – SPOR Plans
Q1 - Q2 2017:
Q4 2018: P&SMS It 1 Phase
P&SMS project
1 delivers Art 57 Migration.
started.
Q4 2017: MAH Q1 2018: Q3 2018: CAP & NAP
content is available. Sponsor content Manufacturers are
is available. available.
Q4 2017: Integrate
OMS with ECD. Q4 2018: Integrate Q4 2018: Integrate
RMS & OMS RMS & OMS with Art
with CT Portal. 57/xEVMPD.
Q4 2017: Integrate
OMS with eAF; RMS Q3/Q4 2018:
Q4 2018: (draft) API
already integrated Integrate RMS &
specs & User On-
with eAF. OMS
boarding strategy.
with CESSP (MAA).
Q4 2017: TOM Q1 2018: Q3-Q4 2018:
(draft) agreed. Messaging Format (draft) Data scope; Migration & Agency
agreed. Validation strategy; Business Relocation
processes (Ph1) are available.
Q2 2017: 2017-2018: 2017: Users start using 2018: RMS & OMS 2018: Guidance is
Remaining SPOR Organisation data is SPOR Target Operating master data is integrated available to support
projects ongoing. incrementally Model for pre-registration of with business processes Industry and
available. R & O data to improve i.e it is entered once and regulators
regulatory submissions. reused across different implementing SPOR.
business processes.
10 © EMA 2016P&SMS projects
• P&SMS project was initiated early 2017
• Considering:
– Project vision and scope
– Available capabilities and skill set
– Brexit and other constraints
• The approach the EU network is taking:
– PMS implementation is led and undertaken by EMA
– SMS implementation is shared as follows:
• SMS - IDMP light – implemented by EMA
• EU SRS - ISO IDMP compliant – implemented by MEB (NL)
11
© EMA 2016PMS
• PMS Iteration 1 will be the first iteration of ISO IDMP 11615
and 11616 compatible data management solution for authorised
human & veterinary products. It will support generation and
maintenance of MPID, PhPID & PCID
• To fully address the implementation of IDMP 11238 further projects
will be required
• PMS Iteration 1 has been divided into multiple phases. Phase 1,
before relocation, is an EMA internal delivery comprising:
• A new ISO IDMP compliant Master Data Managemnet (MDM) hub (also
covering Veterinary and other needs)
• Two way synchronisation of medicinal product information (including
S, R and O) between Art.57 database and the new MDM solution
• Data Quality (DQ) assurance/data entry of human medicinal Product
information by EMA and possibly by some NCAs
12
© EMA 2016EU SMS projects
SMS implementation is shared as follows:
SMS EU SRS
“IDMP light” ISO IDMP compliant
• Who: Implemented by EMA • Who: Implemented by MEB (NL)
• Data: SMS data is the “simplified” PUBLIC • Data: EU SRS contains ISO IDMP substance data
substance data, that supports selection in that supports scientific identification of
regulatory processes and therefore enables you substances. It includes PUBLIC and
to distinguish two or more similar substances CONFIDENTIAL information subject to controlled
access
• Technology: SMS solution covers:
• Search, browse and export of PUBLIC • Technology: EU SRS solution covers only
substance data Substance data management
• Management of substance change requests • Software development/implementation led by
• Translation management NL in the short term in collaboration with
EMA, under EU Telematics governance
• Software maintenance to be transferred to
EMA
• Process/People: EMA provides a broker • Process/People: This project is responsible to
service by managing substance requests, set up the EU Substance Validation Group (SVG)
supporting translations and assuring data who will:
quality. • Prepare the EU substance list
• Maintain the EU list by approving substance
requests and managing substance data
13
© EMA 2016SMS
• SMS Iteration 1 will be the will be the first iteration towards
ISO IDMP 11238 compatible data management solution for
substances
• To fully address the implementation of IDMP 11238 further projects
will be required
• SMS Iteration 1 has been divided into two phases. Phase 1,
before relocation, is an EMA internal delivery comprising :
• New MDM hub for the substnace management service
• Migration of substance data from multiple EMA sources (EV H,
EUTCT H, EUTCT V, EV V) to MDM hub, which support future
consolidation and synchronisation
• This data is not yet mapped to other external sources such as G-SRS
• Management of substance data as per current process/DQ
standards
14
© EMA 2016EU SRS
• In parallel to SMS Phase 1, EU SRS project led by MEB (NL)
will:
• Set up SVG
• Set up initial EU list by consolidation of FDA + NCA + EMA lists in
English and with some translations
• Prepare EU SRS implementation
15
© EMA 2016C. EU Guidance
16
© EMA 2016EU Guidance Process
Develop/Test Start
Draft EU IG Finalise EU IG Enforcement
/UAT API Transition
2018: Not before 2019: Not before 2019: Not before 2020: Not before 2021:
Several sections of PMS API UAT: (Final) EU IG is Industry can start Enforcement:
EU IG available: • Minor available: to submit product Industry can only
• (Draft) API changes/improve • API specs information using submit product
specs ments are • Data fields & new IDMP information using
• (Draft) Data expected as business rules; compatible format new IDMP
fields & business result of API • User onboarding to comply with Art compatible format
rules; development and strategy; 57 to comply with Art
• User on-boarding testing • User registration • EU IG + 12 57
strategy; process; months • Transition + 12
• User registration • Data Migration months
process; strategy;
• Data Migration • Data
strategy; Validation/DQ
• Data assurance
Validation/DQ strategy
assurance • TOM
strategy • Submission/Re
• (Draft) TOM gistration
process
17
© EMA 2016EU Guidance and Relevant milestones for Human Industry
Not before
2018-2019: Not before 2021:
2020:
Revised plans published Enforcement:
2017: Start Transition:
Industry can only
High-level principles Industry can start
submit product
agreed: to submit product
information using
• Data scope; information using
2018: new IDMP
• Migration & Validation new IDMP
Several sections of EU IG Not before 2019: compatible format
strategy; compatible format
available: Several sections of to comply with Art
• Business processes to comply with Art
• (Draft) API specs EU IG available: 57
(Ph1) 57
• (Draft) Data fields & • TOM
business rules; • Submission/Reg Not before 2020:
2017: • User onboarding istration P&SMS It 1 Phase 4
(Draft) TOM strategy; process delivers the Human
• User registration Products
process; Target Operating Model:
• Data Migration strategy; Not before 2019:
• PMS collects
• Data Validation/DQ PMS API UAT
(new/updated) product
assurance strategy data submitted by
Not before 2019: Industry via
(Final) EU IG is eAF/CESSP to support
2018:
available all regulatory
Messaging Format agreed
processes including
Art. 57
Agency
Relocation
(Draft) Sections of EU IG enable 12 months available for Transition period
to plan in 2018 and start some preparatory work since extended to 12 months
preparatory work 2019 (final) EU IG is published to
18 start of Transition
© EMA 2016EU Guidance and Relevant milestones for Vet Industry
2018-2019:
Revised plans published
2017: Not before 2020:
High-level principles Legacy data will be transmitted by
agreed: 2018: NCAs to Eudrapharm/PMS (NVR Art
Not before 2019:
• Data scope; Several sections of EU IG 51)
Several sections of
• Validation strategy; available:
EU IG available:
• Business processes • (Draft) API specs
• TOM
(Ph1) • (Draft) Data fields & Not before 2020:
• Submission/Reg
business rules; P&SMS It 1 Phase 4 delivers the Vet
istration
• User onboarding Products Target Operating Model:
process
strategy; • PMS collects (new/updated)
• User registration product data submitted by
2017: process; Not before 2019: Industry via eAF/CESSP (not more
(Draft) TOM • Data Validation/DQ PMS API UAT data than eAF!)
assurance strategy • Assessment/validation of that
Not before 2019: product data is solely the
(Final) EU IG is responsibility of NCAs
2018: • EMA acts as custodian
available
Messaging Format agreed
Agency
Relocation
P&SMS TOM ensures data is
validated by NCAs so only
trusted substance and
product data is available for
use in regulatory processes
Documentation produced The current plan does not require Industry to backfill
enables vet Industry to be details on already approved products (the provisions of
aware of developments and pharmacovigilance Art.57 do not apply to veterinary
19 prepare for future process
medicines)
© EMA 2016EU Guidance and Relevant milestones for NCAs
2017: 2018: 2018-2019: Not before 2019:
High-level principles OMS content is expanded: Not before 2020:
Revised plans EU Substance list
agreed: MAH> CAP Manufacturers> A core set of product
published is available
• Data scope; NAP Manufacturers data is validated by
• Validation strategy; NCAs and available
• Business processes Not before 2019: for use in regulatory
2018: Several sections of
(Ph1) products
Several sections of EU IG EU IG available:
available: • TOM
2017: • (Draft) API specs Not before 2020:
• Submission/Reg P&SMS It 1 Phase 4
(Draft) TOM • (Draft) Data fields & istration
business rules; delivers the Human
process Products
• Data Validation/DQ
assurance strategy – Target Operating
Agency
Validation of legacydata Model
Relocation Not before 2019:
PMS API UAT
2018: 2020: Human NCAs
Messaging Format agreed check product data
Not before 2019:
in their systems
(Final) EU IG is
against PMS
available
Vet NCAs send a
2016-2018: NCAs to map the referentials in their systems core set of product
against RMS data to
EudraPharm/PMS
2018-2019: NCAs to map the Organisations in their systems
against OMS
2019-2020: NCAs to map the Substances in
their systems against SMS
P&SMS TOM ensures data is
validated by NCAs so only
trusted substance and
product data is available for
20 use in regulatory processes
© EMA 2016D. Future
21
© EMA 2016The journey ahead (2019 +) – SPOR Roadmap
EU Implementation P&SMS It 1 Phase 5 delivers
Guides are available Integrate P&SMS
PMS User Interface Integrate P&SMS
with Regulatory
processes with CT processes
P&SMS It 1 Phase 2 P&SMS It 1 Phase 6 delivers
delivers PMS API & the Veterinary Products
SMS ISO 11238 Target Operating Model
Compliant data Integrate P&SMS
with PhVig processes
Enforcement: Industry can
P&SMS It 1 Phase 3 delivers only submit product
Migration of Vet products information using new IDMP P&SMS Iteration 2
compatible format opportunity to
P&SMS It 1 Phase 4 delivers expand scope, eg
the Human Products P&SMS It 1 Phase 7 Investigational
Target Operating Model delivers reporting & Medicinal Products
document
management P&SMS Iteration 3
Start Transition: Industry
further opportunity
can start to submit product
to expand scope
information using new IDMP
e.g. Clinical
compatible format
Particulars
Agency
Relocation
P&SMS TOM ensures data is SPOR master data is
SMS implements PMS implements
validated by NCAs so only integrated with business
ISO11238; makes ISO11615 and
trusted substance and processes i.e it is entered
EMA regulatory ISO11616 standards;
product data is available for once and reused across
compliant. makes EMA regulatory
use in regulatory processes. different business processes.
compliant.
P&SMS Iteration 1 covers authorised
22 human & veterinary medicinal products.
© EMA 2016PMS
• PMS Iteration 1 has been divided into multiple phases. After
relocation PMS will deliver:
• Authorised human & veterinary medicinal products accessible via a
web User Interface (UI) and SPOR Application Programming Interface
(APIs)
• New ISO IDMP compliant message
• Products Target Operating Model
– No changes to regulatory processes (including timelines as well as roles and
responsibilities)
– Simultaneous submission of product information to NCAs as part of
regulatory procedures and registration in PMS to support multiple use cases
– New ways to assess information electronically
23
© EMA 2016(Draft) PMS Target Operating Model
EU Phase NCA Phase Post-MA Phase
MAH NCA (RMS) MAH NCA (RMS/CMS) MAH EMA
eCTD/VNeeS Common EU National Details assigned Closing Details added by
details details by NCA sequence EMA
eAF/CESSP
Data set
PMS
Similar regulatory procedures
Only minor changes to regulatory procedures (same timelines as well as roles and
All required
responsabilities)
product/procedure data
submitted in the same New digital ways of working
way to: Align evaluation of dataset as part of regulatory process
• NCAs as per current Different parts of the data (data groups) are processed in different steps of the regulatory process
submission to support
regulatory procedures
(MAA & var/ren) and EU data National data NCA data MAH data
groups Additional data
groups groups groups
other such as • Added by MAH • Added by MAH group
• Added by RMS/CMS • Added by MAH • Added by EMA
withdrawals, • Validated by RMS • Validated by • Examples: After approval
RMS/CMS
• • Examples:
• Examples: • Date of approval No regulator
corrections, etc • Name • Examples:
• • EURD Identifier
• MA number validation
• EMA/PMS (closing • Active substance • Legal basis for the • Examples:
• Dosage Form supply • Sales start
sequence) to be re- Strength • Risk of shortage
used in regulatory • Agreed new
fields for Art 57
procedures and
(Human only)
support multiple use
cases PMS TOM ensures:
• Clearer governance and ownership of data
24 • Data is validated by NCAs so only trusted product data is available for use in regulatory
processes © EMA 2016SMS
• SMS Iteration 1 has been divided into two phases. After
relocation SMS will deliver:
• Substances accessible via a web User Interface (UI) and SPOR
Application Programming Interface (APIs)
• Synchronisation with EU SRS
• Substances Target Operating Model
– New process for industry and NCAs to pre-register/update Substance data
before submitting regulatory applications
– EU-US alignment
– Substance data is assessed in parallel with MA review
– Substance data is approved before conclusion of regulatory processes
25
© EMA 2016(Draft) SMS Target Operating Model
Industry/requestor EMA SVG FDA SVG EMA
Substance Substance request Substance Substance Substance Substance request
request validation assessment alignment approval outcome
SMS SMS EU SRS G SRS EU SRS SMS
• Triage requests • Assess substance • Assess substance • Update Substance
• Request new/updated • Close Substance
• Create • Register • Register UNII with Global IDMP
Substance request
PROVISIONAL PROVISIONAL • Register Global code + EU IDMP ID
• No need for • Inform
Substance ID (SMS- substance ID (EU IDMP code + SMS ID
complete ISO Industry/requestor
ID) IDMP ID) • Update substance
information in
structured way (but • Inform status
option available) Industry/requestor • Inform EMA of
• Submission of • Inform SVG outcome
supporting
documentation eg EU-US alignement EU SRS-SMS sync
Mod 3/Part II
Regulatory submission ( e.g. MAA) review
Substance can be
used in regulatory
submissions
SMS TOM ensures:
• Regulatory processes can start as soon as substance is Provisionally registered
• EU-US alignment
• Data is approved by SVG before conclusion of regulatory processes i.e only trusted data is used in regulatory
processes
26
© EMA 2016E. Data Migration Strategy
27
© EMA 2016Migration Strategy
Industry TOM (Start
EMA migration PMS API Enforcement
enrichment Transition)
2018: Not before 2019: Not before 2019: Not before 2021:
EMA Migration: PMS API: Industry is Not before 2020: Enforcement:
• EMA migrates • Industry expected to Industry can start to (Using RIM or PMS
xEVMPD data into solutions (RIM) validate the data submit product capabilities)
PMS can import/pull migrated/ information using new Industry can only
• PMS has same Product data transformed from IDMP compatible format submit product
data content as from PMS API Art 57 and to: information using
xEVMPD (ISO message) enrich/transform • comply with Art 57 new IDMP
• PMS data is the data as per and/or compatible format
transformed into specifications in • support any to:
a new ISO the EU IG: regulatory procedure • comply with Art
compatible • Industry can (TOM) 57 and/or
format (as perform Industry can also use • support any
possible) validation/enrich the PMS UI to: regulatory
ment via own • Export product data – procedure (TOM)
RIM solution ISO message, xls
• Perform their own
validation/enrichment
Data submitted by
Industry overwrites
previous versions in
PMS
Data submitted by
Industry is DQ assured
by NCAs (also creates a
new version)
28
© EMA 20163. SPOR in the Regulatory
context
An agency of the European Union
© EMA 2016R & O (& S) in the Regulatory context
App Form
App Form
Does correct Complete and
Prepare Y Receive App
Referential submit App
Application Form Form
data exist? Form
Start
N Process
SPOR Refreshed data application
automatically pulled
into IT systems
Access SPOR to NCAs do not
check Master data need to review
SPOR master
data, only
confirm it has
been approved
SPOR
Master data
exists
Confirmation of
Conclude
registration or update
application
N Y Finish
Submit request to Submit change • Industry needs to go to
include new request to update SPOR and pre-register
SPOR
Master data Master data new/updated data.
• NCAs do not need to
review master data, only
SPOR = Single source of master data confirm it has been
approved.
30
© EMA 2016SPOR integration with eAF
31
© EMA 2016SPOR as an enabler for process changes (1/2)
Handling variations Type 1, where there is administrative change (12% of total variations)
As Is today
Manufacturer Manufacturer MAH update the product Each MAH informs the NCAs
name change informs each MAH information (*) relevant NCA (legal
(contractual (*) - several products belonging to the same obligation - variation)
obligation) MAH can be impacted
Product A
in Germany
MAH 1
Product B
in Germany
Manufacturer MAH 2
Product C
in Germany
MAH 3
32 © EMA 2016SPOR as an enabler for process changes (2/2)
Handling variations Type 1, where there is administrative change (12% of total variations)
How SPOR can improve the process and how it could work with ROG
Pre-requisite: there is a regulatory change
(process, communication)
SPOR ROG
Manufacturer Data entered by MAH or NCA & MAH are All products automatically
name change Manufacturer automatically informed updated or flagged for updating
Manufacturer SPOR
33 SPOR
33
© EMA 2016Thank you for your attention
Further information
Please send any queries regarding the IDMP/SPOR to:
SPOR-Change-Liaisons@ema.europa.eu
European Medicines Agency
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Send a question via our website www.ema.europa.eu/contact
Follow us on @EMA_News
© EMA 2016Glossary
Backward Capability of a new solution to successfully interface/work with previous versions of
compatibility software/hardware.
CESSP The Common European Single Submission Portal (CESSP) is an ongoing Telematics
programme that aims to integrate the electronic Application Form (eAF) data sets in to
CESP. CESP is the current submission channel for all procedures (not technically
integrated with eAF).
Controlled (aka Referentials) are lists of terms that refer to attributes of medicinal and
vocabularies pharmaceutical products e.g. dosage form, route of administration, unit of measurement.
CT Portal (aka EU Portal and Database) will be the upgraded version of Eudra CT enabling a
single entry point for submission and assessment of clinical trial applications at an EU
level.
eAF The eAF is a collection of Application Forms that facilitate electronic submission of data
relating to Renewals, Variations, Marketing Authorisation Applications (Human & Vet).
Eudra CT The existing platform for submitting and viewing information relating to regulatory
activities relating to Clinical Trials.
EUTCT A repository and provider of controlled terms (or controlled vocabularies) in multiple
languages. It is the predecessor of RMS. RMS will replace EUTCT with regards to
management of controlled vocabularies. EUTCT can only be fully replaced after SMS
implementation as it also contains substances.
Unique The ISO IDMP standards outline a set of attributes/data elements that make up a
identifiers unique identifier . This enables the creation of a unique record for each medicinal
35 product, packaged product, pharmaceutical product, substance and referential. © EMA 2016You can also read
