In 2016, the Implementation Working Group completed its second edition of Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA.
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, the MedDRA Maintenance and Support Services Organization (MSSO), the Japanese Maintenance Organization (JMO), the ICH MedDRA Management Board and the ICH Secretariat.
Since 2003, the various CIOMS Groups responsible for Standardised MedDRA Queries (SMQs) have developed over 100 SMQs. The Working Group met from 2003 –2008 when it downsized to a Core Group (CG), which has since met on regular basis in order to maintain, review and update as required the existing SMQs and consider newly suggested candidate SMQs.
In 2003, a Memorandum of Understanding between CIOMS and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) was drafted regarding the SMQ project. This was 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 of work has been developed and is supported by the MSSO and by the ICH MedDRA Advisory Panel. The work continues to be conducted under the Memorandum of Understanding between CIOMS and IFPMA for the SMQ project.
In 2012, an Implementation Working Group (IWG) was formed to support the continued development and implementation of SMQs and review proposals for new SMQ topics. This IWG meets twice per year. The IWG also produced a second edition of “Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA” (also known as the Red Book), which was published in August 2016.
Participants at the Working Group meeting in Geneva 22-23 March 2017.
The CIOMS MedDRA Implementation Working Group (IWG) met in Geneva from 22-23 March 2017 and was attended by 18 representatives from regulatory and pharmaceutical organizations, as well as academia, the MedDRA Maintenance and Support Services Organization (MSSO) and the Japanese Maintenance Organization (JMO).
The teams charged with developing specific Candidate Standardised MedDRA Queries (SMQs), e.g. SMQs for Dehydration, for Hypokalaemia and for Hallucinations, presented their test results and findings to the IWG for discussion, bringing these SMQs forward in a well-established process towards production. In parallel, the IWG continued to tackle two extremely challenging topics by further testing and refining Candidate SMQs for Opportunistic infections and for Infusion related reactions.
In addition, the IWG discussed ongoing work on a Concept Paper that explores the feasibility of developing groupings of MedDRA terms for use in presentation of safety information in the labelling of medicinal products.
11 December 2018
CIOMS 85th Executive Committee Meeting
08 - 09 October 2018
3rd meeting of Clinical Research in Resource-Limited Settings Working Group
11 - 12 September 2018
14th Meeting of the Implementation Working Group on MedDRA
08 - 09 May 2018