Transcript IDMP_Activity_Update_Vada_Perkins

EU and USA Harmonisation of Content and
Message Exchange for IDMP Implementation
Vada A. Perkins
HL7 Structured Product Labeling (SPL)
specification as enabler of EU/US exchange of
medicinal product information
HL7 SPL(R7) Publication
• HL7 SPL(R7) Publication: To be submitted by this Friday (ballot approved)
• SPL Release 7 as the data exchange format to support ISO IDMP Technical
Specifications. The ISO IDMP Technical Specifications describes the data
exchange for the five (5) ISO International Standards
• Incorporates European Union (EU)/European Medicines Agency (EMA)
requirements for EU implementation of the five IDMP standards utilizing
HL7 SPL to support their legislative requirements for product registration
and pharmacovigilance.
– 92 data elements
– SmPC requirements
ISO IDMP Normative Standard e-Message for
Data Exchange:
Common Product Model (CPM)
The Health Level Seven (HL7) Common Product
Model (CPM) provides:
Overarching information model
Reusable Common Message Element Types (CMETs)
Consistent data types and conformance rules
Vocabulary domains
Schemas for data exchange
Style Sheet View/Source Code (XML)
5
FDA Relevant “SPOR”
• Registrant
–
–
–
–
Contact
Address
Telephone number
Email address
• Establishment/Facility
–
–
–
–
–
–
–
–
Name (business)
Contact
Address
Telephone number
Email address
ID (DUNS, FDA ID, EMA/EU ID)
Business Operations
GPS coordinates
• Importer
–
–
–
–
–
–
Contact
Address
Telephone number
Email address
ID (DUNS, FDA ID, EMA/EU ID)
GPS coordinates
• In Country Contact (e.g., US Agent)
–
–
–
–
–
–
Name (business)
Contact
Address
Telephone number
Email address
(DUNS, FDA ID, EMA/EU, ID)
Medicinal Product
MPID
Combined Pharmaceitical Dose Form
IMPID Corss-Reference
Additional monitoring indicator
Orphan Designation Status
Name (Med.Product)
Invented Name Part
Scientific Name Part
Strength Name Part
EMA/EU Data Elements
Marketing Authorisation
Marketing Authorisation Number
Country
Legal Status of Supply
Authorisation Status
Authorisation Status Date
Date of First Authorisation
Procedure Identifier/Number
(e.g. MRP number)
Procedure Type (e.g. MRP/DCP)
Country (national authorisation)
Marketing Authorization Number
(national authorisation)
Pharmaceutical Dose Form Part
Formulation Part
Intended Use Part
Target Population Part
Container or Pack Part
Device Name Part
Trademark or Company Name Part
Time/Period Part
Flavour Part
Classification System
Classification System Value
Version Date
Version Identifier
Document Type
Document Identifier
Regulated Document
Document Effective Date
Country
Language
Organisation (e.g. MAH, QPPV, PSMFL)
Identifier
Role
Location Address
Location Role
Entity Identifier (according to Role e.g. PSMF ID)
Marketing information
Country
Marketing Status
Marketing Date
Risk of shortage supply
Risk of shortage supply comment
Pharmaceutical Products
Administrable Dose Form
Unit of Presentation
Route of Administration
PhPID Identifier Sets
Device Type (combined medical device ATMP)
Device Trade Name (combined medical device ATMP)
Ingredient
Ingredient Role
Substance
Specified Substance
Confidentiality Indicator
Strength Range (Presentation)
Strength Range (Concentration)
Reference Strength Substance
Reference Strength Specified Substance
Reference Strength Range
Package description
PCID
Package Description
Package Item (Container) Type
Package Item (Container) Quantity
Material
Component Type
Component Material
Manufactured Dose Form
Unit of Presentation
Manufactured Item Quantity
Device Type
Device Trade Name
• Around 20 data elements were removed/ streamlined/
re-modelled
→ 74 Data elements in PMS Iteration 1
• If it is agreed to include 5 data elements to cover
Shortage and Marketing information
→ Total 79 Data elements in PMS Iteration 1
Indication
Indication Text
Indication as "Disease/ Symptom/ Procedure"
Co-Morbidity
Intended Effect
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Language/Code
<!-- SPL header -->
<document>
<id root="1d90e8f0-2065-4f8c-a85a-9a186904fc14"/>
<code code="34391-3" displayName="human prescription drug label"
codeSystem="2.16.840.1.113883.6.1"/>
<languageCode code="en_US" codeSystem="2.16.840.1.113883.6.121">
and the section:
<section>
<id root="be362bdc-9458-4625-ba03-d663b4534962"/>
<code code="34089-3" displayName="description section"
codeSystem="2.16.840.1.113883.6.1"/>
<text>Description</text>
<text>Goodmedicine is a white to off-white powder ...</text>
<languageCode code="en_US" codeSystem="2.16.840.1.113883.6.121">
Link to the Original Source of
Translation
<!-- SPL header -->
<document>
<id root="e56fef83-7eff-41d1-a122-fa5cac99317c"/>
<code code="34391-3" displayName="human prescription drug label"
codeSystem="2.16.840.1.113883.6.1"/>
<languageCode code="fr_FR" codeSystem="2.16.840.1.113883.6.121">
<setId root="20d9b74e-e3d8-4511-9df9-cec2087372fc"/>
<versionNumber value="1"/>
<relatedDocument typeCode="DRIV">
<relatedDocument>
<id root="1d90e8f0-2065-4f8c-a85a-9a186904fc14"/>
</relatedDocument>
</relatedDocument>
Package and Submission of
Multiple Translations
• When required, each SPL file (having one
language) should be packaged in its own
folder. The name of the folder may contain the
language code
Implementing IDMP: The Pivotal Role of the
PhPID (Pharmaceutical Product Identification)
Paracetamol (aka acetaminophen)
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Paracetamol/Acetaminophen
• PhPID_SUB_L1 
• PhPID_SUB_L1 
• PhPID_SUB_L1
paracetamol
paracetamol
 paracetamol
PhPID_SUB_L2 
PhPID_SUB_L2
• PhPID_SUB_L2 
paracetamol, 750 mg
 paracetamol,
paracetamol, 1000 mg
500 mg
• PhPID_ SUB _L3 
• PhPID_ SUB _L3 
paracetamol, tablet• PhPID_ SUB _L3
paracetamol, tablet
film coated
 paracetamol,
• PhPID_ SUB _L4
capsule
paracetamol, 1000 • PhPID_ SUB _L4
paracetamol, 750
• PhPID_ SUB _L4
mg, tablet
mg, tablet-film coated
paracetamol,
500 mg, capsule
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FDA algorithm
(beta) for PhPID
Generation
Substance 1
Dose form
Input
NCI thesaurus
code
Substa
nce ID
UNII
code
Strength
Normalized
unit
Substance 2
Substa
nce ID
UNII
code
MD5
digestion
Output
Strength
Substance n
・・・
Alphabetic order
of UNII code
Normalized
unit
MD5 is a widely used algorithm for hash
function.
PhPID code (example)
128 bit (16 byte) number which, in hexadecimal presentation, is 32 digits long
formatted in groups of 8-4-4-4-12 digits separated by hyphens
-Globally Unique Identifier (GUID)
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ISO “SPOR”: Global Harmoni(sz)ation
• Medicinal Product ID (MPID)
▫ Regional Identification
• Pharmaceutical Product ID (PhPID)
▫ IDMP (algorithm)
▫ Based on core elements for identification of medicinal
products
▫ Demands harmonization of terminologies/IDs for globally
unique identification (internal and external to EU).
• Substances
▫ Global Substance Registration System (G-SRS)
▫ EMA/EU-FDA Bilateral (governance)
• Units of measurement
▫ Unified Code for Units of Measure (UCUM)
• Dosage forms-mapping exercise (ongoing)
• European Directorate for the Quality of Medicines (EDQM)
15
Policy Pathways to
Implementing IDMP in the
US (FDA)
OpenMedicine
20 June2016
Mary Ann Slack (CDER)
Vada A. Perkins (CBER)
16
Overall high level plan for SPOR (updated)
Transition Phase
Preparation
Phase
Product & Substance
Product &
Substance
Submission
Pre-Submission
R
• Build technical services
• Controlled
vocabularies for IDMP
• Build technical services
• Initial organisation
dictionary
O
P
S
• Finalisation of ISO
documentation
(standards review and
Technical
Specifications)
July
2016
Legal deadline
Maintenance
Phase
• Terminology alignment
• Registration of new terms
• Expand and manage content
• Terminology alignment
• Finalisation of EU
Implementation Guides (EU
IGs)
Q3/Q4
2016
• Preparation for electronic
submission
• Terminology alignment
(continuation)
Q1/Q2
2017
Publication of EU IGs
• Implementation
of initial
electronic
submission
Q1/Q2
2018
Kick off Product &
Substance Iteration 1
• Expand and
manage
content (based
on Iterations)
Q3/Q4
2018
Enforcement of Product &
Substance Iteration 1
Why Implement IDMP?
• FDA needs to be able to organize and “connect” relevant data to
support both pre-market and post-market activities
• FDA and other regulatory authorities need to share information
to aid in safety and compliance activities
Example: identifying global drug safety issues
• Product information must be consistently described to be
understandable across regional boundaries
• A common exchange structure enables sharing critical data
Medicinal product identification and SPL enable
this organizing and sharing this data
18
How Might FDA Implement IDMP?
• Through regulation
• Through guidance
• With the enactment of FDASIA in 2012,
through “binding” guidance
19
What is a Statute?
A statute is a law passed by the U.S. Congress
Examples:
• Food, Drug and Cosmetic Act, 1938 (established
what is now the U.S. FDA)
• Food and Drug Administration Science and
Innovation Act (FDASIA), 2012
20
What is a Regulation?
A rule issued by FDA consistent with U.S. law,
published in the U.S. Federal Register and contained
in the Code of Federal Regulations (CFR)
Functions of regulations:
Protect patients from harmful medical
products
Facilitate the availability of beneficial
medical products to patients
21
What is U.S. FDA Guidance?
• FDA’s current thinking on how to comply with a
particular statutory, regulatory requirement or
issue
• A guidance, unlike a statute or regulation, does not
establish “legally enforceable rights or
responsibilities” and do not bind the public or FDA
• Generally, guidance is prepared by FDA staff
22
When Does FDA Issue Guidance?
To announce its interpretation of a statutory or
regulatory requirement for the 1st time.
When guidance is required by a statute.
When guidance is useful to explain how to
implement a statute or regulation.
When guidance would provide more
transparency and clarity in its scientific thinking.
When the “current thinking” changes.
23
Food and Drug Administration
Safety and Innovation Act, July 2012
• Congress authorized FDA to implement statutory
electronic submission requirements by specifying
the format for such submissions in guidance
• Section 745A(a) – Drugs and Biologics
– Applies to all submissions for INDs, NDAs, ANDAs and
BLAs, including supplements, DMFs, and drug/device
combination products
– Noncommercial IND exemption
• Unlike our usual ‘Guidance for Industry’ documents,
this guidance is binding.
24
FDA Safety and Innovation Act (FDASIA)
• Section 1136 of FDASIA (Jul 9,
2012) amended the FD&C Act by
adding new section 745A, which
addresses electronic submissions.
• Starting 24 months after final
guidance for a specific submission
type, Sponsors must use the
standards defined in the data
standards catalog (for submissions
for NDAs, ANDAs, and BLAs).
• Guidance document for Submissions Under Section 745A(a):
– Effective date: December 2016 (CDISC: SDTM)
– Effective date: May 2017 (e-CTD)
25
How may required eSubmissions
be Implemented?
Individual
Guidances
24 Months
after Final
Guidance
NDAs,
ANDAs, BLAs, INDs
• Timetable
• Content
• Format
26
FDASIA Guidance
Implementation Highlights
27
In Summary
• FDA is working to implement IDMP internally
• Pathways exist for recommending or
requiring standardized electronic submission
of IDMP data
• If FDA determines that the best path is to
require standardized electronic submissions,
that requirement would be a minimum of 24
months after final guidance is issued.
28
Paper to Electronic Submission (HL7 CPM/SPL, eCTD)
Transition phase to ISO IDMP Publication
2004
**
US
FDA
HL7
ISO
2005
2006
2007
Content
of
Labeling
SPL (R1)
SPL (R2)
2008
SPL
Indexing
SPL (R3)
2009
2010
2011
2012
2014
2013
2015
Establishment
Registration/Drug
Product Listing
GDUFA Self-ID of
Facilities, Sites,
Organization
LDD,
WDD/3PL,
3911
SPL (R4)
HL7 V3
(Normative to
ISO IDMP)
SPL(R6)
&(R7)/
CPM (R2)
&(R3)
ISO IDMP
New Work
Item (NWI)
Proposals
Publication of
ISO IDMP
Standards
SPL(R5)
2016/2017
FR Notice/
Guidance
(Draft)
IDMP TS/Standards
Revision
(5 year cycle)
US FDA IDMP Roadmap
**US FDA SPL Implementation Guide (technical specification) updated with corresponding Guidance for Industry (incorporated by reference)
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm2005542.htm
Reference:
Vada Perkins
ISO /FDA IDMP Topic Lead/Expert
29
FDA Implemented (IDMP/SPL)
30
Global Identification of Medicinal Products (IDMP) Lifecycle
SPOR