mpns idmp iso poster jnpc 2016
TRANSCRIPT
Part_descriptionPart: LeafCountry: China, Jiangsu & Sichuan Provinces
ISO Identification of Medicinal Products (IDMP) and its implication for herbals
Elizabeth Dauncey; Nicholas Black; Sarah E Edwards; Jason Irving; Kristina Patmore; Robert Allkin
Partners & Collaborators
www.kew.org/MPNS
@MPNS_Kew
Contact
In partnership with MAPROW database -
Medicinal & Aromatic Plant Resources of the World
What is IDMP?
A series of standards from the International Organization for Standardization (ISO) set out the elements required for the identification of medicinal products (IDMP), including one for substances1,2.
IDMP addresses a worldwide demand for internationally harmonised specifications for medicinal products, in order to
simplify the exchange of data between regulators
improve pharmacovigilance and signal detection for adverse reactions
facilitate product recalls
It has been adopted by the EU, the USA, Japan, and many other countries.
IDMP is being introduced for the registration of medicinal products in the EU from the last quarter of 2016, with full implementation envisaged in 2018. This will have implications for manufacturers of plant-based products regulated in the EU as medicines (herbal medicinal products), who will be required to submit data to EMA in accordance with the formats and terminologies set out in IDMP.
IDMP provides the conceptual framework for defining substances, and for assigning unique identifiers. It defines substances based on their scientific identity (i.e. what they are) rather than their use or method of production. Plants, and other organisms, are defined by their scientific name with author. The use of scientific names will address the serious health consequences that have arisen from use of other classes of name to identify herbal medicines3.
References:1. ISO 11238:2012. Health Informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on substances. Prepared by Technical Committee ISO/TC 215, Health Informatics. ISO; 2012: 1 - 412. ISO 19844:2015. Health Informatics -- Identification of medicinal products -- Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances. ISO; 2015: 1 - 2603. Debelle FD, Vanherweghem J-L, Nortier JL. Aristolochic acid nephropathy: a worldwide problem. Kidney Int 2008; 74(2): 158 – 1694. Paton A, Allkin R, Belyaeva I, Dauncey E, Govaerts R, Edwards S, Irving J, Leon C, Nic Lughadha E. Plant name resources: building bridges with users. In: Botanists of the 21st century: roles, challenges and opportunities. UNESCO Int. Conference, Paris, France, 2014. UNESCO; 2016: 207 – 216.
Kew's Medicinal Plant Names Services4 (www.kew.org/mpns) is the maintenance authority for two controlled vocabularies (CVs) for IDMP, one for plant parts and the other for scientific plant names. These CVs are vital for consistency, efficient communication and the ability to find all products relating to one plant regardless of the alternative names used in the different jurisdictions regulating them. The final structure and content of these controlled vocabularies reflect regulatory demands, the wider IDMP goals and the complexity of scientific nomenclature.
MPNS A Global Resource for
Medicinal Plant Names
Defining substances Scientific names for Herbal Medicines
Botanical Knowledge
Domain Knowledge
391,000 species worldwide
c.1.6 million scientific names for plants
c. 10,000 name changes published each year
Curated Kew resources regularly updated
14,000 medicinal plants covered 90,000 names used within herbal
medicine research & regulation, including:• 4,000 pharmaceutical names as
published in pharmacopoeias• 50,000 common names & drug
names• 21,000 scientific names
Services&
Web Portal
An abbreviated example for the Substance (Herbal drug) - Ginkgo biloba, Leaf
OrganismKingdom: PlantaeFamily: GinkgoaceaeGenus: GinkgoSpecies: bilobaSpecies Primary Author: L.
Source materialSource_Material_Class: OrganicSource_Material_Type: PlantOrganism_name: Ginkgo biloba L.Development Stage: Mature plantParent_substance_name: Ginkgo biloba L., Leaf = Substance (fresh)Fraction (e.g. for extracts)
Material_Type: HerbalFraction: Dry ExtractCountry: China
Reference sourceType: Ph.Eur.Class: Official Name SourceCitation: Ph.Eur. monograph no: 01/2011:1828
Reference source documentDocument: 'Text, in attachment'Type: Regulatory submissionAttachment: Macroscopic characters of the leaf
Controlled Vocabulary
CV