ICH Announces New Guideline on Data Collection

Published on: 

At ICH’s November 2016 meeting, the council announced new members and new guidelines.

The International Council for Harmonization (ICH) announced it was developing a new guideline on the collection of safety data during late-stage premarket and post-approval clinical investigations of new drugs. The announcement follows a meeting held on November 17, 2016 in Osaka, Japan. The council also announced the addition of new members and the adoption of an amendment to the ICH good clinical practice guideline.

ICH stated in a press release that the decision to create a new guideline (ICH E19) for data collection came as a result of increased interest in collecting data on the long-term effects of drugs.  The new guideline will harmonize requirements for the optimal collection of safety data to “improve global health by encouraging study on long-term effects, rare events and new indications of drugs through reducing resources required for these studies.”

The adoption of an amendment to ICH E6 (ICH E6(R2)) was also announced at the meeting. The amendment “aims to encourage sponsors to implement improved oversight and management of clinical trials, while continuing to ensure protection of human subjects participating in trials and clinical trial data integrity.”

Other guideline news included the development of a question and answer document on ICH Q11 to clarify implementation issues and the finalization and adoption of ICH Q3C(R6) on residual solvents.


As part of its objective to extend its global outreach, ICH welcomed new members, including the Agência Nacional de Vigilância Sanitária (ANVISA) from Brazil, the Ministry of Food and Drug Safety (MFDS) from South Korea, and the Biotechnology Innovation Organization (BIO). New ICH Observers announced at the meeting were Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED), Cuba; National Center for the Expertise of Drugs, Medical Devices and Equipment (National Center), Kazakhstan; Medicines Control Council (MCC), South Africa; and Active Pharmaceutical Ingredients Committee (APIC).

Source: ICH