ICH Opens Up Management Committee To Regulators From China, Singapore, South Korea
The ICH has now largely finished implementing its structural and organizational reforms by adding new regulatory and industry members to the organization. The reform process aims to increase ICH's international outreach and turn it into a “truly global initiative.”
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The Quality Lowdown: ICH Q13 and Q14, Gene Therapy CMC, Drug Shortage Gaps, And An Excipient Misstep
ICH launches continuous manufacturing and analytical procedure guidelines while US FDA promises advice on gene therapy CMC, battles drug shortages and sees what went wrong with certain eye injections.
The move recognizes the expertise that generic and biosimilar drug developers can bring to the scientific discussions at the International Council on Harmonisation.