ISO Identification of Medicinal Products (IDMP) and its implication for herbals Elizabeth Dauncey; Nicholas Black; Sarah E Edwards; Jason Irving; Kristina Patmore; Robert Allkin
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.
Defining substances
Scientific names for Herbal Medicines
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.
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.
An abbreviated example for the Substance (Herbal drug) - Ginkgo biloba, Leaf Source material
Part_description
CV Part: Leaf Country: China, Jiangsu & Sichuan Provinces Fraction (e.g. for extracts) Material_Type: Herbal Fraction: Dry Extract Country: China
Source_Material_Class: Organic Source_Material_Type: Plant Organism_name: Ginkgo biloba L. Development Stage: Mature plant Parent_substance_name: Ginkgo biloba L., Leaf = Substance (fresh)
Services & Web Portal
MPNS A Global Resource for Medicinal Plant Names
Domain Knowledge
Controlled Vocabulary
Botanical Knowledge
Organism
Reference source Type: Ph.Eur. Class: Official Name Source Citation: Ph.Eur. monograph no: 01/2011:1828
Kingdom: Plantae Family: Ginkgoaceae Genus: Ginkgo Species: biloba Species Primary Author: L.
Reference source document Document: 'Text, in attachment' Type: Regulatory submission Attachment: Macroscopic characters of the leaf
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
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
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 - 41 2. 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 - 260 3. Debelle FD, Vanherweghem J-L, Nortier JL. Aristolochic acid nephropathy: a worldwide problem. Kidney Int 2008; 74(2): 158 – 169 4. 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.
Partners & Collaborators
Contact www.kew.org/MPNS In partnership with MAPROW database Medicinal & Aromatic Plant Resources of the World
[email protected] @MPNS_Kew
