MedDRA, or the Medical Dictionary of Regulatory activities, contains standardised medical terminology to facilitate sharing of drug regulatory information internationally according to International Conference on Harmonisation (ICH) spokeswoman, Cornelia Meyer.
She told in-Pharmatechnologist.com that: “MedDRA is used by both regulatory authorities and the pharmaceutical industries in the ICH regions [US, Japan and EU] and increasingly beyond the ICH regions.”
“The information coded in MedDRA by the companies is shared with the regulators to meet their regulatory requirements” Meyer added.
Prior to the launch of MedDRA, no standard international regulatory terminology reference existed. Instead global drugmakers needed to understand and comply with differing terminologies such as the US FDA’s COSTART, WHO-ART, J-ART, H-ARTS, ICD-9 and ICD-9CM depending in which region they were working.
This prompted, in 1993, the European Union to develop standard terminology that could be used cross regionally, based on the UK Medicines and Healthcare Products Regulatory Agency (MHRA) existing MEDDRA programme. The resulting MedDRA standards were adopted by the ICH in 1994 and launched in 1999.
Responsibility for managing and maintaining security of the standards, as well as the MedDRA Desktop Browser that enables users to search for regulatory terminology online in different languages, was contracted to Northrop Grumman.
War on international regulatory terminology interoperability
Although better known as a developer of aircraft, missile IT systems and contractor for the US war on drugs, Northrop also provides cybersecurity and computer interoperability services and it was these capabilities that won it the MedDRA contract according to Meyer.
She told us that: “The first MSSO [MSSO (Maintenance and Support Services Organization] services contract was awarded in coordination with the launch of MedDRA in 1999 and it has remained with the same contractor since then.
Meyer added that: “ICH has decided that a new call for tender should be undertaken to conform with good business practices and does not reflect on the performance of the current contractor.”
The ICH is accepting tenders from August 15 through to October 31, 2014.
Northrop did not respond to a request for comment.