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          ICH Q12: Implementation Considerations for FDA-Regulated ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	ICH Q12: Implementation Considerations for FDA-Regulated Products
		 
			Draft Guidance for Industry
		
		May 2021


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft
		
		    		Level 1 Guidance

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2021-D-0166
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research
          Center for Devices and Radiological Health


The International Council for Harmonisation (ICH) guidance for industry Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its Annexes (ICH Q12, May 2021) provide a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. ICH Q12 includes regulatory tools and enablers with associated guiding principles that should enhance industry’s ability to manage postapproval changes and increase transparency between industry and regulatory authorities, supporting innovation and continual improvement.



FEDERAL REGISTER NOTICES:

The original notice announcing availability of the guidance
	The new notice about the reopening of the comment periodSubmit Comments
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						All written comments should be identified with this document's docket number: FDA-2021-D-0166.

                                                                                  Content current as of:
      09/10/2021
         
                  
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