International – ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry

A recently released survey from the International Council on Harmonisation (ICH) shows pharmaceutical regulators and companies around the world are adopting and adhering to the council’s guidelines related to quality, safety and efficacy.

The survey of 32 pharmaceutical companies provided responses on 15 regulatory authorities, which included the founding ICH members: the European Medicines Agency, the US Food and Drug Administration, Japan’s MHLW/PMDA, Health Canada and Swissmedic, as well as other newcomers from Brazil, China, Singapore and South Korea, and observers from Malaysia, Russia, South Africa and Turkey.

Implementation of ICH guidelines was highest among the five founding ICH members, although guidelines on Q1, related to stability, Q7, on good manufacturing practices for active pharmaceutical ingredients and E6(R2) – Good Clinical Practice were uniformly implemented across just about all of the regulators surveyed…