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picture1_Pharmaceuticals Pdf 151940 | Doc Actd Re1 Quality


picture2_Pharmaceuticals Pdf 151940 | Doc Actd Re1 Quality picture3_Pharmaceuticals Pdf 151940 | Doc Actd Re1 Quality

 97x       Filetype PDF       File size 0.69 MB       Source: asean.org


File: Pharmaceuticals Pdf 151940 | Doc Actd Re1 Quality
THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Part II: QUALITY TABLE OF CONTENTS Scope of the Guideline .. 8 Section A: Table of Contents ...

icon picture PDF Filetype PDF | Posted on 15 Jan 2023 | 2 years ago

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...The asean common technical dossier actd for registration of pharmaceuticals human use part ii quality table contents scope guideline section a b overall summary c body data drug substance product d list key literature reference annex version revision date status author th ppwg meeting adopted accsq endorsed by ad referendum as this document is intended to provide guidance on format application products regarding ctr appropriate nce new chemical entity biologics biotechnological and vaccines mav major variations miv minor g generics actr only provides requirements variation should be made who guidelines procedures changes approved biotherapeutic trs respectively determine applicability particular type applicant consult with national regulatory authorities in merely indicates where information located neither nor extent specific supporting has been addressed both may depend upon or accepted leading international references pharmacopoeias please refer relevant ich filed provided qos no pa...
								

							

						
	
												
				
					
					
					
			
					
				
				
		
	

	
		





	

	
				

						

						
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										Category:  Uncategorized / Uncategorized 
										
Posted on: 15 Jan 2023 | 2 years ago
										
										
Tag:
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Filetype: PDF
										
File size: 0.69 MB
										
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										Wan learn
											

												Wan learn