Building a link between ectd and xevmpd

Building a link between eCTD
and XEVMPD
Samarind Webinar – 21st June 2013
Michiel Stam
Qdossier B.V.

21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 2
Agenda
Why new pharmacovigilance regulation?
• Improve signal detection by more specifically attribute adverse
events to medicines
• XEVMPD is just one of the tools for pharmacovigilance
Other (Pharmacovigilance) documentation needs to be
considered in this context
• Overview of all kind of structured information requested in the EU
What to learn
• Conclusions

Need to improve public health
Medicines save lives and relieve suffering, but….
• Can also cause side effects
• 5% of all hospital admissions
• Nearly 200,000 deaths per year in the EU
Promote and protect public health by
• Reducing burden of side effects
• Optimizing the use of medicines

Considering
Data collection and management
Benefit-Risk assessment
Signal detection
Safety Issue evaluation
Regulatory action
Communication
Audit

Impacts
Actors
• EMA (PRAC)
• NCAs
• Pharmaceutical companies
• Patients and Health Care
Professionals
Entire product lifecycle
Estimated to save
between 500 and 5000
lives per year
• savings to society of €250-
2,500 million/year

How?
All MSs introduce direct consumer reporting
Establishment of PhVg Risk Assessment Committee
(PRAC)
Robust EU decision making
Engaging patients and health care professionals
Science based
Risk proportionate
Greater proactivity
Reduced duplication and greater efficiency
Increased transparency and better information

Direct consumer reporting

Tasks
Industry:
• Maintain PhVg System Master File
• Regulatory documents in eCTD (incl. cover letter, application form)
• PSURs evaluate benefit-risk; not only focus on safety
• Modular RMP
• Summary of PhVg System master file
PRAC to provide expert advice on safety and benefit-risk
Transparency and communication
• Coordination of PhVg inspections
• Routine PhVg audits
• Better funding for public health protection
Better definition of intervening medicinal products
• XEVMPD (To be submitted by XEVPRMs)

SFDA campaign food additives

Marketing License through CTD
ICSRs
by
E2B
PhVg
System
Master
File by
GVP
ICSRs
Manu-
facturing
License
through
GMP
WW
MA
status
RMP
Interface
Patient benefit/risk ratio

EU Envelope

Cover letter Initial MAA + Variations

Cover letter Post-authorisation commitments

Application form 1

Application form – 2, etc

RMP Part I “Product overview”
Active substance information:
• active substance(s); ATC code; name MAH or applicant; date and
country of first authorisation; date and country of first launch
worldwide; number of medicinal product(s) to which this RMP refers.
Administrative information on the RMP:
• DLP RMP; date submitted and version No.; list of RMP modules
(incl. date and version No.)
• for each medicinal product included in the RMP:
• authorisation procedure; invented name(s) in EEA;
• brief description of the product (incl. chemical class)
• indications:
• dosage:
• pharmaceutical forms and strengths:

RMP part II “Safety specification”
Module SI Epidemiology of the indication(s) and target
population(s)
Module SII Non-clinical part of the safety specification
Module SIII Clinical trial exposure
Module SIV Populations not studied in clinical trials
Module SV Post-authorisation experience
Module SVI Additional EU requirements for the safety
specification
Module SVII Identified and potential risks
Module SVIII Summary of the safety concerns

RMP Interface ToC

RMP interface – Administrative

RMP interface – Product

RMP interface – Indications

RMP interface – Risks

RMP interface – Interactions

RMP interface – Missing information

New PSUR - mandated since 10 Jan 2013
Part of a regulatory submission (e)CTD Module 5.3.6
Benefit-risk (not only safety) and cumulative
• Based on AEs instead of ADRs
• More structured evaluation based on cumulative data
• No summary bridging reports or addendum reports
• No acceptance of multiple 6 monthly reports
Assessment leads to automatic regulatory action
• variation, suspension, revocation
Submission frequency will be variable (based on risks)
EMA list of substances with submission dates
• Union Reference Dates and periodicity of submissions (EURD) list

(EURD) European Union reference date

PhVg System Master File (on file only,
replacing DDPS in dossiers)
General details
• EV code or local code (XEVMPD)
• Name of MAH, the MAH of the
QPPV (if different), relevant
QPPV 3rd party (if applicable)
• Name of concerned MAH(s)
• List of PhVg system master files
with different PhVg system
• Date of preparation/last update
MAH organization
Sources of safety data
Computerized systems and
databases
QPPV particulars
PhVg processes
PhVg system performance
Quality system
Related documents
• List of products covered by this
PhVg MF, incl.
• MA #, Rapporteur or RMS, market
presence
• Other (non-EU) territories
• Specific safety monitoring
requirements
• Roles and Responsibilities if 3rd
parties are involved
Upon request, a Change control logbook, versions and archiving details may be requested

Summary of PSMF (mandated >July 2015)
Replacing the DDPS in dossiers
Proof that Company has a QPPV at its disposal
Statement of pharmacovigilance competence
Member states in which QPPV resides and carries out his
tasks
QPPV contact details
PSMF location (Code as in XEVMPD)

XEVMPD database filled by industry, owned
by EMA (mandated >2 July 2012)
Organization (MAH and QPPV details)
ATC code (as in SmPC)
Pharmaceutical Form (EMA vocabulary)
Route of administration (EMA vocabulary)
Substance (EMA vocabulary)
• Structured substance information not mandated yet
• Would have much more data
Product details
• Next slide
Attachment
• corresponding SmPC for verification
QPPV details

Example of Product details

Conclusion
What to learn from all these formats and forms
requesting structured information?

Conclusion CMC its relation to XEVMPD
Regulatory information should be reused at various
eCTD documents, RMP interface and XEVMPD/IDMP
How?
• Develop internal standards
• Leverage (do not copy!) from existing standards
• Inherit values across disciplines, documents and tools
• Define mapping and automate correlation to other standards
• Envelope, cover letter, application form, XEVMPD, IDMP,
Module 3, etc.
Manage properly the regional aliases and translations, to support
beyond the EU too

Building a link between ectd and xevmpd

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