Regulatory Focus™ > News Articles > Updated: ICH Updates on MedDRA, New Members and Guidelines

Updated: ICH Updates on MedDRA, New Members and Guidelines

Posted 04 December 2017 | By Michael Mezher 

Updated: ICH Updates on MedDRA, New Members and Guidelines

The International Council for Harmonisation (ICH) on Thursday provided guidance and other updates, inaddition to news on developments for the Medical Dictionary for Regulatory Activities (MedDRA), following a recent meeting of the MedDRA management committee in Geneva, Switzerland.

MedDRA was initially developed by ICH in the late 1990s to provide standardized medical terminology for regulatory purposes and is available at no cost to regulators and to drugmakers on a sliding scale based on the company's annual revenue.

Beginning next year, ICH says subscription rates to MedDRA will drop again, following a reduction in rates for 2017.

"With over 5,000 subscribing organizations in more than 110 countries, the costs of maintaining and developing the terminology can be distributed over a wider base," ICH writes.

According to ICH, the World Health Organization's (WHO) Uppsala Monitoring Centre is coordinating with MedDRA to assist countries in transitioning away from WHO-ART (WHO Adverse Reaction Terminology) to MedDRA.

ICH also touted MedDRA's global training efforts in 2017, with free trainings provided to more than 3,000 participants via webinars and face-to-face sessions in Brazil, Canada, China, Europe, Mexico, Russia and the US.

Beginning in 2018 ICH says MedDRA will begin providing local language training support in countries in Central America and South Korea, and in China in 2019.

ICH also announced MedDRA will be translated into Korean and Russian to bring the total number of languages the dictionary is available in to 13.

ICH M1 Points to Consider

Earlier this year, ICH announced plans to develop companion documents to its M1 Points to Consider (PtC) document.

ICH says its PtC Working Group has now completed the first draft of the companion document, which addresses data quality issues and medication errors, which it plans to release in 2018.

ICH Assembly Updates

The ICH Assembly also met in November and approved several new ICH members and advanced work on several guidelines.

Singapore's Health Sciences Authority (HSA) joined the harmonization body as a new regulatory member and Colombia's Intituto Nacional de Vigilancia de Medicamentos y Ailmentos (INVIMA) and the Bill & Melinda Gates Foundation joined as observers.

The Assembly also reelected Lenita Lindström-Gommers and Toshiyoshi Tominaga as Chair and Vice-Chair of the Assembly for a two-year term, and reelected Theresa Mullin and Toshiyoshi Tominaga as Chair and Vice Chair of ICH's Management Committee.

ICH also moved to adopt its E17 guideline on planning and designing multi-regional clinical trials (MRCTs) and said that dedicating training and implementation materials will be developed to help implement the guideline.

"Facilitating the conduct and acceptability of MRCTs is expected to have a direct public health benefit, in particular by encouraging more predictability around the approval of trials and the use of clinical trial data from a greater variety of countries and regions," ICH said.

And ICH moved to begin a 12-month public consultation on its draft Q12 guideline, which aims to provide a framework for pharmaceutical lifecycle management for manufacturing changes to already approved drugs.

The Assembly also established a pediatric expert working group and said that work is already underway on an earlier announced guideline on pediatric extrapolation.

Work towards ICH's planned revision of its 1997 E8 guideline on good clinical practice (GCP) also advanced with the adoption of a concept paper and business plan.

ICH

Editor's note: This article was updated to include updates from the ICH Assembly Meeting in Geneva, Switzerland in November.


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe