my question is regarding ICH guideline.
what is the difference between of Member country and Observer Country and what is the benefits to member country?
Is china now included a member country or already member from previously?
ICH is a body comprised of six bodies that includes both regulatory bodies of US, Japan and EU and pharmaceutical association of three nation’s namely PhRMA, JPMA and EFPIA. These three are the member countries of ICH. Observers include WHO, EFTA and Canada. Member countries determines the policies and procedures for ICH, selected topics for harmonization and monitored the progress of harmonization. While observer bodies nominates the secratariate that represents these bodies in ICH but do not have the voting right in ICH decision makings.
Hope that helps