ICH Q11 Development and Manufacture of Drug Substance

raft Draft Draft Step e ic ICH Harmonation or marim Topic Reference: 011 STEP 2 EXPERTS Q11: Development and Manufacture of Drug Substances Consensus on a document to be submitted to the ICH Steering Committee under Step 2 of the ICH Process Step 2 Experts Document signed off by the DESIGNATED EXPERTS FROM THE ICH EXPERT WORKING GROUP The official ICH procedure specifies that a Step 2 Document can be submitted to the SC for endorsement when the Designated Experts of the six ICH parties reach consensus and sigu the Step 2 Siguoff sheet. Document reference Document Date: ICH Parties ICH Q11, Step 2 28 April 2011 Kem MCMALD Pude Zuz EXC EFPIA Slate. Buy had MHLW ALTER BRENDAN HUGHES Dave 11 May 2011 *May 2011 May 10 all. Tergoddesh Anda 101ay 2011 Koji Takaki KOJI TAKAKI 10 May 2011 JOHN L SMITH 5/9/2011 Chantytes/a/n A A few more revisions A lot more teleconferences And then finally reached consensus Step 2 May 2011 JPMA FDA² 3/23/12 ICH PhRMA Autochel P.IV Bulay Fritschol My Ar wep 2, The Steering Commune agencias for wider, formal consultation in accordance with their normal ernal or external consultation procedure AS e document to the inte regional reginatory Due to its structured the representation of both CBER and CDER in ICH FDA May nammate wo Topic Leaders, one per Center (depending on the scope of the topic)

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