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.



“In general, authorities declared that Guidelines were mostly implemented without modifications,” the survey says. “The proportion of modifications was highest for Observers [Malaysia, Russia et al.], followed by Regulatory Members and finally Founding/Standing Regulatory Members. In addition, some Guidelines had more modifications e.g. Q1, Q7, E2D [which deals with post-approval safety data management].”

Where there were modifications, the survey says that, “[A]ll the authorities felt that these were justified i.e. to provide clarity and facilitate implementation by industry, but do not increase regulatory requirements.”
Companies’ perceptions on guideline implementation were “generally aligned” with agency perceptions, the survey notes, but some differences were noted – “e.g. E2B [on clinical safety data management] and M8 [electronic common technical document], which should be explored further.”

And when guideline implementation was confirmed, all the regulators said they felt that they were adhering to the guidelines, “i.e. adequately applying them in day-to-day practice. In general, company perception and self-declaration of the authority was aligned or too early to assess based on limited experience.”

At a joint public consultation in Ottawa on Monday, officials from Health Canada and FDA also gave an overview of the progress made on more than two dozen ICH guidelines ahead of the upcoming ICH Assembly meeting in Singapore later this month.

ICH Survey