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ICH

@ich_news

International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use

ID: 305434870

linkhttp://www.ich.org calendar_today26-05-2011 06:29:14

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ICH is pleased to announce the publication of a press release following the meeting of the ICH Assembly in Vancouver, Canada held on 12 & 13 June 2023. See the press release: bit.ly/3qSGvzC

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ICH announces collaboration between MedDRA and WHO International Classification of Diseases (ICD) #ICH #WHO #MEDDRA #ICD #PublicHealth #GlobalHealth See the press release: bit.ly/3XzCjRx

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ICH is pleased to announce that the ICH Reflection Paper on Real-World Evidence Terminology is now available for public consultation. For more information, please see: bit.ly/3r3Cok9

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ICH is pleased to announce the publication of a press release following the meeting of the ICH Assembly in Prague, Czech Republic held on 31 October & 1 November 2023. See the press release: bit.ly/3Qt2sym

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ICH has launched recently a request for proposal and seeks technical/regulatory writing services to support the drafting activities associated with ICH guideline development in support of ICH EWG Member and Observer representatives. For more information: bit.ly/3sUpOVJ

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ICH is pleased to announce that the ICH E2D(R1) draft Guideline reached Step 2 of the ICH process and now enters the public regulatory consultation period. For more information, see bit.ly/3SVxLnQ

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ICH is pleased to announce that the ICH Q3C(R9) Guideline for Residual Solvents was revised using the ICH Minor Revision Procedure and has reached Step 4 of the ICH Process. For more information see: bit.ly/49gITBp

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ICH is pleased to announce that a Step 4 Introductory Training Presentation on the ICH Q2(R2)/Q14 Guideline on Analytical Procedure Development has been developed by the ICH Q2(R2)/Q14 EWG and is now available online. For more information, bit.ly/4bQp8Sd

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ICH is pleased to announce that the ICH M14 draft Guideline reached Step 2 of the ICH process and now enters the public regulatory consultation period. For more information, see bit.ly/3WXexk6

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The ICH M12 Guideline on Drug Interaction Studies has reached Step 4 of the ICH Process. For more information, see bit.ly/4bxpf5d

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ICH is pleased to announce that a Step 4 Introductory Training Presentation on the ICH M12 Guideline on Drug Interaction Studies has been developed by the ICH M12 EWG and is now available online. For more information, bit.ly/4bxpf5d

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ICH is pleased to announce the publication of a press release following the meeting of the ICH Assembly in Fukuoka, Japan held on 4 & 5 June 2024. See the press release: bit.ly/4bfEgYN

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ICH is pleased to announce that ICH M13A Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms has reached Step 4 of the ICH process and a Step 4 Introductory Training Presentation has been developed by the WG, available here: bit.ly/46uALwP

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ICH is pleased to announced that ICH E11A Guideline on Paediatric Extrapolation has reached Step 4 of the ICH process. For more information, see bit.ly/3YUe5nY

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ICH is pleased to announce that a Step 4 Introductory Training Presentation on the ICH E11A Guideline on Paediatric Extrapolation has been developed by the ICH E11A EWG and is now available online. For more information, see bit.ly/3zmYFOH

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ICH is pleased to announce the publication of a press release following the meeting of the ICH Assembly in Montréal, Canada held on 5 & 6 November 2024. See the press release: bit.ly/3O9vjqJ

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The ICH E6(R3) Annex 2 draft Guideline on Good Clinical Practice reached Step 2b of the ICH Process on 6 November 2024 and entered the public consultation period. A Step 2 Informational Presentation has also been developed by the E6(R3) Annex 2 Subgroup: bit.ly/3CBAu0a

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ICH is pleased to announce the appointment of Géraldine Lissalde-Bonnet as Secretary General of the ICH Secretariat. See the press release: bit.ly/3OWIf3D

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ICH is pleased to announced that ICH E6(R3) Guideline on Good Clinical Practice has reached Step 4 of the ICH process. For more information, see bit.ly/4ahezIa

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ICH is pleased to announce the publication of a press release following the meeting of the ICH Assembly in Madrid, Spain held on 13 & 14 May 2025. See the press release: bit.ly/3SJw3oz