CIOMS Working Group on Standardised MedDRA Queries (SMQs)

Historically, the project began in 2003 as a CIOMS initiative, in response to indications received from some drug regulatory authorities and pharmaceutical companies that they had concerns about the parallel development of special drug safety search programs based on the Medical Dictionary for Regulatory Activities (MedDRA). This would cause an unavoidable duplication of effort and uncertainty within pharmaceutical companies about the utility of these searches on the part of drug regulatory authorities.

The drug regulatory authorities and pharmaceutical companies identified a need to harmonize and standardize their adverse drug reaction database search queries based on MedDRA in order to use the terminology in a rational way and to allow comparisons of drug safety findings between different databases. However, at an early stage it became clear that such an activity would benefit from cooperation among all stakeholders, i.e. the CIOMS Working Group, MedDRA/Maintenance and Support Services Organization (MSSO), the ICH MedDRA Management Board and the ICH Secretariat.

Since 2003 the CIOMS Working Group on Standardised MedDRA Queries (SMQs) has developed search queries for some 95 selected adverse drug reactions. The Working Group met 22 times from 2003 - 2008 when it downsized to a Core Group, which has since met 5 times in order to maintain, review and update as required the existing SMQs and consider newly suggested candidate SMQs. There were 86 SMQs level 1 and an additional 4 SMQs to be released at the time of the MedDRA 15.0 introduction in March 2012, indicating that a total of 90 SMQs will be available to MedDRA users. A total of 90 SMQs will complete the originally contemplated work programme for SMQ development.

In 2003, a Memorandum of Understanding between CIOMS and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) was drafted regarding the SMQ project. This was most recently reviewed in 2011 to address the future activities of the CIOMS SMQ CG. The agreement is also a link with ICH for which IFPMA functions as a Secretariat. A revised scope has within the previous Working Group been developed, presented and supported by MSSO and by the ICH MedDRA Advisory Panel. The Work will continue to be conducted under a Memorandum of Understanding between CIOMS and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), which owns MedDRA as trustee for the ICH Steering Committee.

The CG will be transformed to an Implementation Group (IWG ) and the revised scope is broadened with more height on being supportive of the implementation of SMQs and reviewing so-called “home-grown queries” and also include an updated 2nd Edition CIOMS SMQ Red Book.

 

 

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