The newly renamed International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is looking to bring more pharmaceutical and medical device regulators into its ranks as members and observers.
Begun in 1990 by EU, US and Japanese regulators as a way to further harmonize regulations on safety, efficacy, quality and data standards across the globe, with progress in developing more than 80 guidelines on such topics, as well as work on MedDRA (Medical Dictionary for Regulatory Activities) and the CTD (Common Technical Document) and eCTDs. The council is now set on becoming an even more international organization, with an interest in adding regulators from other jurisdictions, particularly in China, and other regulatory member groups.
Cathy Parker, director general of Health Canada’s Biologics and Genetic Therapies Directorate, told participants at the US Food and Drug Administration/Health Canada Regional ICH Public Consultation on Friday that ICH recognizes the significance of sharing expertise with regulators, particularly in China, which has become a global hub for drug manufacturing.
Most recently, the council has added the WHO and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) as standing observers, while Health Canada and Switzerland’s drug and device regulator SwissMedic became full members in 2014.
“The benefits of harmonization have been made abundantly clear,” Parker said, noting the council intends to further reduce the cost and time for regulators and industry to bring safe and effective products to market.
She also noted that the eligibility criteria for becoming a new observer of ICH is “quite basic” and groups dealing with pharmaceutical regulations and other industry associations can attend ICH meetings as an observer but cannot vote or appoint experts in working groups.
The ICH assembly and 10 working groups will meet in Lisbon, Portugal for face to face meetings from 11-16 June.
International Council for Harmonization Regional Public Consultation