In addition to the blog, we would like to our involvement with IDMP with you in a bit more detail. Also, we would be interested to hear how the new standard may affect your work.
IDMP
IDMP has been published by the International Standards Organisation and is due to be adopted by a number of health regulators including US Food & Drug Administration (FDA) and the European Medicines Agency (EMA). Implementation guides and software to facilitate use of the new standard are currently being developed, and new legislation in the EU is due to come into force next year.
MPNS Involvement
The IDMP standard aims to harmonise data formats to facilitate global sharing of information on medicines. Medicinal products made from plants will be a small (but important!) part of the standard and MPNS has been working closely with regulators to inform the design of the data standard. In addition Liz Dauncey (MPNS) co-authored the herbal supplement to the IDMP Implementation Guide. MPNS is providing controlled vocabularies for use in information systems implementing the standard: one for plant parts and more significantly another for plant names.
MPNS is collaborating further with the US Food and Drug Agency (US FDA) to develop an Application Programming Interface (API) that will maintain the currency of the ISO Plant Names Controlled Vocabulary as Kew botanists extend, improve and update the underlying nomenclatural data sets.
The software under development by US FDA is open source and was recently adopted for use across the EU by the European Medicines Agency (EMA).
MPNS has been advising the British Standard’s Institutes Health Committee and is a member of the EMA’s IDMP Task Force which is planning the implementation of the IDMP standard in time for EU-wide legislation due to come into force during 2016 and 2017.
Health Regulatory Framework Symposium and Workshop
Last year we attended meetings to discuss the IDMP standard. The meetings were hosted in Uppsala by the WHO Monitoring Centre. A 2-day symposium was attended by more than 100 invited regulatory, scientific and industry experts from the US, Canada, Japan and across the EU. It served to present the IDMP standard and to seek feedback from industry. A subsequent 2-day workshop jointly organised by US FDA and EMA brought together those working on implementing IDMP and addressed scientific and IT detail. FDA outlined progress toward an open source system to facilitate implementation of IDMP.
Outcome for Plant Names
We are very pleased to be involved in the development and maintenance of this standard. By maintaining a controlled vocabulary we hope to improve communication between regulators and to enhance the safety with which herbal substances are used and prescribed.
We would welcome your thoughts on this new standard and how it may affect your work.
Best wishes,
The MPNS team
Read more about our work for the IDMP in our blog post
Find out more about the IDMP on the EMA website
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