Showing XXX results across 3 categories.
The ICH M13A draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reached Step 2 of the ICH process on 20 December 2022.
The Assembly of the International Council for Harmonisation (ICH) met in-person on the 15 - 16 November 2022, in Incheon, Republic of Korea in parallel of meetings of ten Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.
The ICH E19 Guideline on A Selective Approach to Safety Data Collection in Specific Late-stage Pre-approval or Post-approval Clinical Trials reached Step 4 of the ICH Process in September 2022.
The ICH M11 draft Guideline on Clinical electronic Structured Harmonised Protocol (CeSHarP), Technical Specification and Template reached Step 2 of the ICH process on 27 September 2022.
The ICH Q5A(R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2 of the ICH process on 29 September 2022.
The ICH E19 Guideline on A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials reached Step 4 of the ICH Process on 27 September 2022.
The Addendum to the ICH S1B Guideline has reached Step 4 of the ICH process on 4 August 2022, being integrated with the original guideline and published as ICH S1B(R1) Testing for Carcinogenicity of Pharmaceuticals.
A Step 2 Informational Presentation has been developed by the M12 Expert Working Group, in follow up to the ICH M12 draft Guideline on Drug Interaction Studies reaching Step 2b of the ICH Process in May 2022.