Pharmaceutical companies are faced with the requirement of submitting data in accordance to the ISO IDMP standard in the EU region by 1 July 2016, mandated by legislation 520/2012 set forth by the EU commission. With FDA following shortly after EMA, the pharmaceutical industry is faced with a significant challenge in preparing and planning for the submission and maintenance of data, ranging from manufacturing data, over structured substance information to registration information amongst others.
The adoption is typically to become compliant with five ISO standards (11615, 11616, 11238, 11239, 11240):
- ISO 11615:2012
Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information - ISO 11616:2012
Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information - ISO 11238:2012
Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances - ISO 11239:2012
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 - ISO 11240:2012
Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement
Also note that another recent standard has been published:
- ISO/TS 16791:2014
Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers
Joint Initiative on SDO Global Health Informatics Standardization
Readings
ISO IDMP will transform your regulatory IT strategy
By Dr. Dieter Schlaps and Dr. Niels Buch Leander, NNIT
ISO IDMP is the next wave in the pharmacovigilance legislation after xEVMPD. But with a global scope and requiring data integration from the entire company it is a much bigger wave. In 2012, the five ISO standards referred to as “ISO IDMP” were approved. Their purpose is to standardise the identification of medicinal products, ultimately leading to improved pharmacovigilance across products, companies and jurisdictions. It has a global scope and in Europe for instance it will take effect by 2016.
More readings from elsewhere: