MSSO, JMO REPORT GROWTH OF THEIR SUBSCRIBER BASES
The Medical Dictionary for Regulatory Activities (MedDRA) Maintenance and Support Services Organization (MSSO) and the Japanese Maintenance Organization (JMO) reported on the growth of their subscriber bases. The number of subscribing organizations to MedDRA is now over 5,000 in 103 countries. This reflects the successful adoption of MedDRA as a worldwide standard in the protection of public health. Future areas of focus for the MSSO include continuing to support the global use of MedDRA and exploring interoperability between MedDRA and other medical terminologies.
The Board of MedDRA-an ICH standardised dictionary of medical terminology, noted that the MSSO and the World Health Organisation (WHO) Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre) held their first joint MedDRA and WHO Drug User Group meetings in Bangalore and Mumbai, India in February 2017. Following this successful collaboration, another joint MedDRA/WHO Drug meeting is planned for Beijing, China in September 2017.
The Board noted the efforts of the ICH M1 Points to Consider (PtC) Working Group in supporting MedDRA’s global uptake. The Working Group has developed condensed versions of the PtC documents for translation into all MedDRA languages (English and Japanese versions will remain in full) to support the implementation and use of MedDRA worldwide. These condensed documents will be made available to MedDRA users in 2017.
The Board also noted that the Working Group has begun development of a companion document to the PtC documents, available in English and Japanese. This document will provide more detailed guidance, examples, and “Questions and Answers” on topics of regulatory importance such as data quality and medication errors. The first edition of the companion document is expected to be available in 2018.
The MSSO reported that the MedDRA Self-Service Application was launched in April 2017. This web-based tool allows MedDRA users to retrieve subscription information and passwords, confirm the subscription status of business partners, and obtain certificates for attending face-to-face training classes.
The Board acknowledged the significant work of the CIOMS SMQ Implementation Working Group (IWG) and noted that one new SMQ Infective pneumonia will go into production in September 2017 for MedDRA Version 20.1.
The Board was also updated on other important initiatives and developments. The MSSO reported on its participation in the Innovative Medicines Initiative’s WEB-RADR (Recognising Adverse Drug Reactions) project and the development of a draft set of “patient friendly terms” to support direct patient reporting through mobile applications and web portals.