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.
Members of the MedDRA Implementation Working Group (picture taken in 2017 in Geneva)
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.
Memorandum of Understanding
Since 2003, CIOMS has collaborated with ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) via a Memorandum of Understanding regarding the development of SMQs.
Implementation Working Group
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 includes representatives of regulatory and pharmaceutical organizations, as well as academia, the MedDRA Maintenance and Support Services Organization (MSSO) and the Japanese Maintenance Organization (JMO), and meets twice per year. Its sub-teams develop specific candidate Standardised MedDRA Queries (SMQs), e.g. SMQs for Dehydration and for Hypokalaemia, which are then taken forward in a well-established process towards production, under the oversight of the MSSO. The IWG has also produced a second edition of “Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA” (known as the Red Book), which was published in August 2016. In parallel, the IWG continued to tackle challenging topics by further testing and refining candidate SMQs, including one for opportunistic infections.
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.
02 - 03 April 2019
15th Meeting of the Implementation Working Group on MedDRA
11 December 2018
CIOMS 85th Executive Committee Meeting
27 - 28 November 2018
4th meeting of Drug Induced Liver Injury Working Group
23 - 24 October 2018