|
- ICH Official web site : ICH
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
- ICH Official web site : ICH
This Guideline has been revised a second time and has reached Step 4 of the ICH process in February 2003 This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for Climatic Zone I and II
- ICH Official web site : ICH
The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories
- ICH HARMONISED GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3)
The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities
- ICH Official web site : ICH
The ICH Secretariat is pleased to announce that the updated ICH E2B(R3) Q As, the Implementation Guide, and Appendix I (G) for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) have reached Step 4 of the ICH Process
- ICH Official web site : ICH
ICH Official web site : ICH
- STABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS Q1
At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures
- ICH Official web site : ICH
The ICH E20 draft Guideline on “Adaptive Design for Clinical Trials” has reached Step 2b of the ICH Process on 25 June 2025 and entered the Step 3 public consultation period
|
|
|