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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
- Quality Guidelines
The ICH Q2(R2) revised Guideline and the Q14 Guideline...
- Ich Guidelines
ICH has produced a comprehensive set of safety Guidelines to...
- Efficacy Guidelines
ICH S7B and ICH E14 describe nonclinical and clinical risk...
- Multidisciplinary Guidelines
The M2 Expert Working Group (EWG) was established by the ICH...
- CTD
For industries, it has eliminated the need to reformat the...
- Members
Dr. Alejandro Ernesto Svarch Pérez COFEPRIS, Mexico. Read...
- MedDRA
The current ICH M1 Points to Consider Working Group develops...
- Electronic Standards (Estri)
E2B(R2) Message Specification and Q&A. The first...
- Mission
ICH's mission is to achieve greater harmonisation worldwide...
- Reflection Papers & Discussion Groups
The ICH Reflection Paper on Patient-Focused Drug Development...
- Quality Guidelines
Articles & Procedures. Work Plans & Reports. Process of Harmonisation. Public Consultations. Guideline Implementation. All Guidelines. Quality Guidelines. Safety Guidelines. Efficacy Guidelines.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public ...
May 21, 2024 · The ICH M14 draft Guideline on “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines” has reached Step 2 of the ICH process on 21 May 2024. The M14 draft Guideline is available for download on the M14 Page. This draft Guideline outlines ...
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