Functional Design ISO/ FDIS-IDMP DATABASE 11238€¦ · Functional Design ISO/ FDIS-IDMP DATABASE 11238 CBG-MEB: Department of Substances Herman Diederik and Ciska G. Matai in cooperation

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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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

Page 3

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Reference Source Code

CV

Language CodeCV

CHEMICAL ABSTRACT NAME * Reference Source Code

CV

CAS REGISTRY NUMBER *


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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CV

Language CodeCV

INN NAME *

INN NAME *


CV

Language CodeCV

INN CHEMICAL NAME OR DESCRIPTION *


CV

Language CodeCV

USP/ NF *


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


Jump to Layer ?Documentation

Martindale

Jump to Layer ?DocumentationUSP Monograph

?

Page 2

Def. Def.

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CV

Language CodeCV

EP *


CV

Language CodeCV

EP * Reference Source Code

CV

EP MONOGRAPH NUMBER


CV

Language CodeCV

COUNTRY NAME *


CV

Language CodeCV

HOMEOPATHIC NAME


CV

EUDRAVIGILANCE SUBSTANCE 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]


MANDATORY OFFICIAL NAMES MANDATORY CODES


MANDATORY COUNTRY NAMES CODES

MANDATORY HOMEOPATHIC NAMES CODES

Page 3

Jump to Layer ?DocumentationEP Monograph

?


RegistrationDossier

Def.

Def.

Def.

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CV

Language CodeCV

OTHER NAME * Reference Source Code

CV

OTHER-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



Jump To STN

Jump to Layer ?Registration

Dossier

MANDATORY HOMEOPATHIC NAMES CODES

Page 4


RegistrationDossier

Def.

Def.

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CV

Language CodeCV

CHEMICAL NAME (STRUCTURALLY RELATED SUBSTANCE)


CV

Language CodeCV



CV

Language CodeCV


MOLECULAR STRUCTURE

MOLECULAR STRUCTURE

MOLECULAR STRUCTURE


CV

Language CodeCV

SUBSTANCE RELATIONSHIP ROLE ISO-IDMP-RELATIONSHIP-ID

MOL. WEIGHT and UNIT




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]


[DIASTERIOMER/ TYPE [S, S]n]


[DIASTERIOMER/ TYPE [R, R]n]


[CHARACTERS]


[CHARACTERS]


[CHARACTERS]


[Isomer type/ Active Moeity/ Impurity/ Degradant/ Metabolite/ Agonist/ Antagonist/ etc]

[CHARACTERS]


[CHARACTERS]


[CHARACTERS]


[CHARACTERS]


[ENANTIOMER/ TYPE [S, R]n]


[CHARACTERS]


[CHARACTERS]


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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Documents

Functional Design ISO/ FDIS-IDMP DATABASE 11238€¦ · Functional Design ISO/ FDIS-IDMP DATABASE 11238 CBG-MEB: Department of Substances Herman Diederik and Ciska G. Matai in cooperation