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Functional Design ISO/ FDIS-IDMP DATABASE 11238CBG-MEB: Department of Substances
Herman Diederik and Ciska G. Matai
in cooperation with
CBG-MEB: Department of PharmacovigilanceAnja van Haren
CBG-MEB: Department of Int. Affairs/ ICHStan van Belkum
February, 2013
C O L L E G E
T E R B E O O R D E L I N G V A N
G E N E E S M I D D E L E N
C B GM E B
M E D I C I N E S
E V A L U A T I O N
B O A R D
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Department of Substances
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Current Substance Registration System
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Current Substance Registration System
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Current Substance Registration System
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Pharmaceutical Product Representation in “ICI”, Tablet
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Active Substance Representation of Pharm. Product, Tablet
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Connection between Naming Active Substance “Dutch name field” and wording in Chapter 2 of SmPC
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Connection between Naming Active Substance “Dutch name field” and wording in Chapter 6 of
Patient Information Leaflet/ Package Leaflet
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Connection between Naming Active Substance “Dutch name field” and wording in Marketing Authorization License
Active Substance Record Representation
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Background
Pharmacovigilance• Identification of the medicinal product involved in the
adverse event report is critical:– Specificity within an adverse event/reaction report– Clear and accurate communication across
jurisdictions (countries & regions)
• More specificity leads to more accuracy in analysis
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European Commission Estimation
• 5% of all hospital admissions due to ADRs
• 5% of all hospital patients experience an ADR
• ADRs 5th most common cause of hospital death
• 197,000 deaths per year in EU caused by ADRs
• Total societal cost €79 billion
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Be aware of the system and your role
Better protecting the patients
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ICH BackgroundICH M5 Objective:
Develop harmonized standards building on the regulatory and technical processes established in the 3 ICH regions and observer countries – Standardize terminology/controlled
vocabulary concepts and models related to medicinal products
– Standardize the exchange format of regulated medicinal product information
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ISO IDMP Standards (1)
Set of 5 International Standards:
• prEN ISO 11615 Health informatics — Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal products
prEN ISO 11616 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
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ISO IDMP Standards (2) prEN ISO 11238 Health Informatics — Identification of
medicinal products — Data elements and structures Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information onsubstances and specified substances
prEN ISO 11239 Health Informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
prEN ISO 11240 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement
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ScopeTogether, these five standards:• Define• Characterize• Uniquely identifyregulated medicinal products for human use
Support the entire product life cycle management:• Development• Authorization (approval)• Post-marketing• Renewal or withdrawal as applicable
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ISO‐IDMP SUBSTANCE DATABASE APPROACH
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CLASSIFICATION SUBSTANCE ISO-IDMP-DATABASE LAYER DEFINITION
Layer 0.0: FLOW CHART CHEMICAL SUBSTANCE
Layer 0 [Chemical Substance] PREFERRED NAME and ISO-IDMP-ID (Parent Substance)
Parent/ Child Specified Substance Name/ ID Group 1, 2, 3Child Substance Name/ ID and
Equivalent Value Child Substance/ Parent Substance
Layer 1 [Chemical Substance] [Naming and Coding of Parent/ Child Substance]
Layer 2 [Chemical Substance] [Molecular Formula, Molecular Weight, Molecular Structure] [Parent/ Child Substance]
Chemical Substance Role Classification of Isomers/ Impurities/ Degradant/ etc:
Chemical Name (Parent Substance and Sructural Related Substance; Molecular Structure an Molecular Weight
Layer 3 [Chemical Substance] [Naming and Coding of Parent/ Child Substance] Specified Substance Group 1
Parent/ Child Substance Specified Substance Group 1 Constituents (Name and ISO-IDMP-ID)
Constituent Role and Properties/ Notes Field
Page 1
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CLASSIFICATION SUBSTANCE ISO-IDMP-DATABASE LAYER DEFINITION continue
Layer 6 [Parent/ Child Substance] Documentation
Public Domain
Restricted Domain Part I(Competent Registration Authority Only)
Restricted Domain Part II(Competent Registration Authority, Edetorial Reviewer Only)
Layer 7 [Chemical Substance] LEGEND
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Reference Source Code
CV
Language CodeCV
CHEMICAL ABSTRACT NAME * Reference Source Code
CV
CAS REGISTRY NUMBER *
Reference Source Code
CV
Language CodeCV
INN NAME *
INN NAME *
ReferenceSource Code
CV
WHO Drug Information *
CA Index Name EN ISO-Code [Field Value]: [ALPHA-NUM-CAP-SIGNS]
[CA INDEX NAME]ISO-CodeCAS Registry number [Field Value]: [NUM-SIGNS]
[NUMBER]
WHO, Martindale EN ISO-Code [Field Value]: [LATIN ALPHABET]
[RECOMMENDED INN LATIN]
[Field Value]: [ALPHA-CAP]
[RECOMMENDED INN ENGLISH]
WHO [Field Value]: [NUM-SIGNS]
[vol. number]; [number]; [year]; [list number]
Layer 1 [Chemical Substance]
Parent / Child
Parent Level 1
Preferred Name Parent Substance
ISO-IDMP-IDParent Substance-ISO-IDMP-ID
MAPMore infomation
Preferred Name Child Substance Salt form-1
Preferred Name Child Substance Salt form-2
Preferred Name Child Substance Salt Hydrate
Preferred Name Child Substance Hydrates
ISO-IDMP-ID Child Substance Salt form-1
ISO-IDMP-ID Child Substance Salt form-2
ISO-IDMP-ID Child Substance Salt Hydrate
ISO-IDMP-ID Child Substance Hydrates
Value< 1,0000
Value< 1,0000
Value< 1,0000
Value< 1,0000
Layer 1 [Naming and Coding of Parent (Child) Substances]
MANDATORY OFFICIAL NAMES MANDATORY CODESJump To
STNJump To
STN
Jump to WHO list
Jump to WHO list
Page 1
Def.
Def.
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Reference Source Code
CV
Language CodeCV
INN NAME *
INN NAME *
Reference Source Code
CV
Language CodeCV
INN CHEMICAL NAME OR DESCRIPTION *
Reference Source Code
CV
Language CodeCV
USP/ NF *
Reference Source Code
CV
Language CodeCV
USP/ NF * Reference Source Code
CV
UNII FDA/ USP SRS *
WHO, Martindale EN ISO-Code [Field Value]: [LATIN (Spanish alphabet)]
[RECOMMENDED INN SPANISH]
[Field Value]: [CYRILLIC (Russian alphabet)]
[RECOMMENDED INN RUSSIAN]
WHO Chemical Name orDescription
EN ISO-Code [Field Value]: [ALPHA-NUM-SIGNS]
[SYSTEMATIC CHEMICAL NAME OR DESCRIPTION]
USP/ NF Chemical Name orDescription EN ISO-Code [Field Value]: [ALPHA-NUM-SIGNS]
[SYSTEMATIC CHEMICAL NAME]
USP/ NF Monograph EN ISO-Code [Field Value]: [ALPHA-NUM-SIGNS]
[MONOGRAPHY NAME]ISO-CodeUNII [Field Value]: [ALPHA-NUM]
[TEN CHARACTERS]
Layer 1 [Naming and Coding of Parent (Child) Substances] continue
MANDATORY OFFICIAL NAMES MANDATORY CODES
Layer 1 [Chemical Substance]
Jump to Layer ?Documentation
Martindale
Jump to Layer ?DocumentationUSP Monograph
?
Page 2
Def. Def.
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Reference Source Code
CV
Language CodeCV
EP *
Reference Source Code
CV
Language CodeCV
EP * Reference Source Code
CV
EP MONOGRAPH NUMBER
Reference Source Code
CV
Language CodeCV
COUNTRY NAME *
Reference Source Code
CV
Language CodeCV
HOMEOPATHIC NAME
Reference Source Code
CV
EUDRAVIGILANCE SUBSTANCE CODE
Reference Source Code
CV
ATC-CODE
EP Definition EN ISO-Code [Field Value]: [ALPHA-NUM-SIGNS]
[SYSTEMATIC CHEMICAL NAME]
EP Monograph EN ISO-Code [Field Value]: [ALPHA-NUM-SIGNS]
[MONOGRAPHY NAME]ISO-CodeEP monograph number [Field Value]: [NUM]
[NUMBER]
EU, US, CAN, JAN Country ISO-Code CountryNL, DE, SE, FR, UK, ... [Field Value]: [ALPHA-NUM-SIGNS]
[COMMON NAME]
EP, DAB (EAB), HAP, HP LA ISO-Code [Field Value]: [ALPHA-NUM-SIGNS]
[SYSTEMATIC HOMEOPATHIC NAME]
ISO-CodeSubstance EV-code [Field Value]: [ALPHA-NUM]
[CHARACTERS]
ISO-CodeATC-code
[Field Value]: [ALPHA-NUM]
[CHARACTERS] [HUMAN]
[CHARACTERS] [VETERINARY]
Layer 1 [Naming and Coding of Parent (Child) Substances] continue
MANDATORY OFFICIAL NAMES MANDATORY CODES
Layer 1 [Chemical Substance]
MANDATORY COUNTRY NAMES CODES
MANDATORY HOMEOPATHIC NAMES CODES
Page 3
Jump to Layer ?DocumentationEP Monograph
?
Jump to Layer ?Documentation
RegistrationDossier
Def.
Def.
Def.
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Reference Source Code
CV
Language CodeCV
OTHER NAME * Reference Source Code
CV
OTHER-CODE
Reference Source Code
CV
Language CodeCV
HOMEOPATHIC NAME
Registration Dossier EN ISO-Code [Field Value]: [ALPHA-NUM-SIGNS]
[SYNONYM NAME]ISO-Code
[Field Value]: [ALPHA-NUM]
[LAB]
[NSC]
EP, DAB (EAB),HAP, HP EN ISO-Code [Field Value]: [ALPHA-NUM-SIGNS]
[SYSTEMATIC HOMEOPATHIC CHEMICAL NAME]
OTHER NAMES, (MANDATORY) CODES
Layer 1 [Naming and Coding of Parent (Child) Substances] continue
Layer 1 [Chemical Substance]
Jump To STN
Jump to Layer ?Registration
Dossier
MANDATORY HOMEOPATHIC NAMES CODES
Page 4
Jump to Layer ?Documentation
RegistrationDossier
Def.
Def.
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Reference Source Code
CV
Language CodeCV
CHEMICAL NAME (STRUCTURALLY RELATED SUBSTANCE)
Reference Source Code
CV
Language CodeCV
CHEMICAL NAME (STRUCTURALLY RELATED SUBSTANCE)
Reference Source Code
CV
Language CodeCV
CHEMICAL NAME (STRUCTURALLY RELATED SUBSTANCE)
MOLECULAR STRUCTURE
MOLECULAR STRUCTURE
MOLECULAR STRUCTURE
Reference Source Code
CV
Language CodeCV
SUBSTANCE RELATIONSHIP ROLE ISO-IDMP-RELATIONSHIP-ID
MOL. WEIGHT and UNIT
MOL. WEIGHT and UNIT
MOL. WEIGHT and UNIT
Reference Source Code
CV
Language CodeCV
CHEMICAL NAME (PARENT SUBSTANCE) MOLECULAR STRUCTURE MOL. WEIGHT and UNIT
Registration Dossier EN ISO-Code
[Field Value]: [ALPHA-NUM-SIGNS]
[ENANTIOMER/ TYPE [R, S]n]
Registration Dossier EN ISO-Code [Field Value]: [ALPHA-NUM-SIGNS]
[DIASTERIOMER/ TYPE [S, S]n]
Registration Dossier EN ISO-Code [Field Value]: [ALPHA-NUM-SIGNS]
[DIASTERIOMER/ TYPE [R, R]n]
[Field Value]: [ALPHA-NUM-SIGNS]
[CHARACTERS]
[Field Value]: [ALPHA-NUM-SIGNS]
[CHARACTERS]
[Field Value]: [ALPHA-NUM-SIGNS]
[CHARACTERS]
Registration Dossier EN ISO-Code [Field Value]: [ALPHA-NUM-SIGNS]
[Isomer type/ Active Moeity/ Impurity/ Degradant/ Metabolite/ Agonist/ Antagonist/ etc]
[CHARACTERS]
[Field Value]: [ALPHA-NUM-SIGNS]
[CHARACTERS]
[Field Value]: [ALPHA-NUM-SIGNS]
[CHARACTERS]
[Field Value]: [ALPHA-NUM-SIGNS]
[CHARACTERS]
Registration Dossier EN ISO-Code [Field Value]: [ALPHA-NUM-SIGNS]
[ENANTIOMER/ TYPE [S, R]n]
[Field Value]: [ALPHA-NUM-SIGNS]
[CHARACTERS]
[Field Value]: [ALPHA-NUM-SIGNS]
[CHARACTERS]
Layer 2 [Chemical Substance]
Page 3
Layer 2 [Naming and Coding of Parent Substance or Child Active Moeity Structural Relationship] continue
Jump to Layer 3Specific Optical
RotationSpecified Substance
Group 1
Rosuvastatin Zinc
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Rosuvastatin Zinc
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Rosuvastatin Zinc
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Documentation Layer
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Linaclotide, Public domain
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Linaclotide, Restricted Domain
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Linaclotide, Restricted Domain
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THANK YOU FOR YOUR ATTENTION
Postal address: P.O. Box 8275 , 3503 RG Utrecht, The NetherlandsMiss Ing. C.G. Matai, Chemist <[email protected]>Drs. H. Diederik, Pharmacist <[email protected]>
Question 1:What is the classification of Teicoplanin according to the ISO‐IDMP‐
11238 Standard
• Answer : The substance is a mixture of components isolated together or produced in the same synthetic process.(The mixture of components appear as an amorphous powder.)
• Conclusion: The substance Teicoplanin will be classified as a Mixture substance, having a Parent Substance ISO-IDMP-ID.
• This mixture substance contains as active multiple active components containing two pairs of constitutional isomers having the same chiral conformation.
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Question 2:Can Lactose monohydrate be considered as the “Child” Substance of the “Parent” Substance Lactose anhydrous?
• Answer 2: YES. • The monohydrate of lactose can be referred to the
anhydrate despite the conformational difference for the alpha or beta isomer of the glucose unit.
• Chiral difference will be captured in the relationship between parent and child substance as defined, e.g. any salt, any salt-hydrate or hydrate form will be related to the parent moiety base or acid form or anhydrate.
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Question 4: How do we classify the complex substance Paclitaxel‐
Albumin in the medicinal product Abraxane?
• Answer 4: The product is presented as a sterile, pyrogen-free, white-to-yellow lyophilized cake formulation of nanoparticles of 100 mg paclitaxel “bound” by 800 mg human albumin.
• The Paclitaxel nanoparticles and the Albumin are substances of diverse origin that are brought together but do not undergo a chemical transformation.
• Therefore the Paclitaxel – Albumin complex can be defined as multi-substance materials and are placed in accordance with the standard in Specified Substance Group 1.
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Phytochemical Record Presentation
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Veterinary Pharmaceutical Product; SPC Composition Record
Veterinary Pharmaceutical Product Representation
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Veterinary Pharm. Product; Active substance Representation
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Veterinary Pharm. Product; Adjuvant Representation
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