International – ICH Offers Updates on Guidelines, Working Groups

In addition to updates on how ICH regulatory members are implementing ICH guidelines, the ICH Assembly at its meeting in Charlotte, NC, on 14-15 November 2018 also was informed of progress made on a survey for monitoring the adequacy of regulators and industry in implementing and adhering to ICH guidelines, according to the recently released minutes of the meeting.

Results from the survey are expected next June, and ICH observers were invited to volunteer to participate, with those who agreed to do so including Malaysia’s NPRA, Mexico’s COFEPRIS and South Africa’s SAHPRA.

The Assembly also approved the application of Iran’s NRA for observership, which means the ICH is now made up of 16 members and 28 observers.

Reflection Papers

The Assembly endorsed as an ICH reflection paper the US Food and Drug Administration’s (FDA) reflection paper on “Further Opportunities for Harmonization of Standards for Generic Drugs,” including minor amendments, and agreed that its publication on the ICH website would be deferred until the approval of the remit of the Informal Generic Drug Discussion Group (IGDDG).