International Council for Harmonisation (ICH) Members agreed upon various moves that would rebuild the ICH’s good clinical practice (GCP) guidelines while in a meeting in Japan in November 2016.
After interactions, ICH said it wants to carry out a broad review of its guidelines relevant to GCP and clinical trial design, starting with a reflection paper expected in early next year.
“This will consist of updating present guidance on interventional trials and extend on novel trial approaches for drug registration like as non-interventional studies, which includes use of new data sources like as real world evidence, patient registries, etc.”
ICH members also chosen to follow an addendum to the organization’s two decade back Guideline for Good Clinical Practice (E6(R1)). The addendum, known as ICH E6(R2), “objective to motivate sponsors to implement enhanced oversight and management of clinical studies, while continuing to make sure protection of subjects taking part in studies and clinical trial data integrity.”
In addition, ICH announced that it will be developing a new guideline (ICH E19) focused at harmonizing specifications for “optimal collection of safety data while in late stage premarket and postapproval clinical investigations of new medicines and new indications for accepted drugs.”
New Members and Observers
ICH also extended its ranks at the meeting by including two new regulatory members,
- Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) and
- South Korea’s Ministry of Food and Drug Safety (MFDS),
along with 4 new observers and an industry association member:
- Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médico –Cuba
- National Center for the Expertise of Drugs, Medical Devies and Equipment (National Center)- Kazahkstan’s
- Medicines Control Council (MCC)-South Africa
- The Active Pharmaceutical Ingredients Committee (APIC)
- The Biotechnology Innovation Organization (BIO)