Regulatory Focus™ > News Articles > ICH Looks to Revamp GCP Guidelines, Adds New Members

ICH Looks to Revamp GCP Guidelines, Adds New Members

Posted 17 November 2016 | By Michael Mezher 

ICH Looks to Revamp GCP Guidelines, Adds New Members

Members of the International Council for Harmonisation (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week.

Following discussions, ICH said it plans to conduct a broad review of its guidelines related to GCP and clinical trial design, beginning with a reflection paper expected in early 2017.

"This will include updating current guidance on interventional trials and expand on novel trial methodologies for drug registration such as non-interventional trials, including use of new data sources such as real world evidence, patient registries, etc.," ICH said.

ICH members also voted to adopt an addendum to the organization's 1996 Guideline for Good Clinical Practice (E6(R1)). The addendum, referred to as ICH E6(R2), "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."

Additionally, ICH announced that it will be creating a new guideline (ICH E19) aimed at harmonizing requirements for "optimal collection of safety data during late stage pre-market and post-approval clinical investigations of new drugs and new indications for approved drugs."

New Members and Observers

ICH also expanded its ranks at the meeting by adding two new regulatory members, Brazil's Agência Nacional de Vigilância Sanitária (ANVISA) and South Korea's Ministry of Food and Drug Safety (MFDS), as well as four new observers and an industry association member:

  • Cuba's Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médico (CECMED)
  • Kazahkstan's National Center for the Expertise of Drugs, Medical Devies and Equipment (National Center)
  • South Africa's Medicines Control Council (MCC)
  • The Active Pharmaceutical Ingredients Committee (APIC)
  • The Biotechnology Innovation Organization (BIO)

ICH, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (E6(R2))


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