Pharma GMP News of the Week: 25-December-2022
Period: December 18, 2022 to December 24, 2022
EU Published guidance “EU Guideline on orphan applications (for designation and transfer) – 2022/C 440/02”
Date of news: December 19, 2022
This guideline provides further guidance on the information sponsors must supply when seeking for orphan medicinal product designation. It encompasses both the structure and the content of the application and should be followed unless there are compelling reasons to deviate from it.
Source: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52022XC1121(01)&from=EN
FDA Published draft guidance “M11 Template: Clinical Electronic Structured Harmonised Protocol”
Date of news: December 21, 2022
This template is designed for interventional clinical studies of medicines, vaccines, and medication/device combos that are intended for drug registration. The template is appropriate for all stages of clinical research as well as all therapeutic disciplines. Its development took into account existing ICH Guidelines and ISO 14155. The template is intended to be customizable for the specific trial. More information and norms about flexibility may be found in the sections below.
Source: m11 template: clinical electronic structured harmonised protocol (cesharp)
FDA Published draft guidance “M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol”
Date of news: December 21, 2022
This document’s objective is to serve as a technical representation of the ICH M11 protocol template. This Technical Specification (TS) is to be aligned with the most recent version of the ICH M11 Guideline and protocol template, but with flexibility in addressing ICH and regional authority data exchange needs.
FDA Published draft guidance “M11 Clinical Electronic Structured Harmonised Protocol”
Date of news: December 21, 2022
The clinical protocol specifies the techniques and procedures that will guide the conduct and analysis of a human clinical study of a pharmaceutical product(s). To date, no internationally recognised harmonised standard for the format and content of the clinical protocol has been created to facilitate uniformity among sponsors and the electronic interchange of protocol information.
Source: https://www.fda.gov/media/164112/download
FDA Published draft guidance “Controlled Correspondence Related to Generic Drug Development”
Date of news: December 21, 2022
This advice explains how generic medication makers and allied industries, or their representatives, can submit restricted communication to the FDA seeking generic drug development information. This guideline also covers the Agency’s procedure for communicating with recipients of such mail.
Source: Controlled Correspondence Related to Generic Drug Development
News from ICH “ICH M13 draft Guideline reaches Step 2 of the ICH process”
Date of news: December 21, 2022
The ICH M13A Guideline is part of the anticipated ICH M13 Guideline series (M13A-C) and is intended to provide recommendations on conducting bioequivalence (BE) studies for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.
Source: https://database.ich.org/sites/default/files/ICH_M13A_Step2_draft_Guideline_2022_1125.pdf
News from EDQM “European Paediatric Formulary: Chloral Hydrate Oral Solution monograph open for public consultation in Pharmeuropa PaedForm”
Date of news: December 21, 2022
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has just published Issue 5 of Pharmeuropa PaedForm, in which the draught text for Chloral hydrate 100 mg/mL Oral Solution is available for public comment prior to its inclusion in the European Paediatric Formulary. The closing date for comments on the text in Pharmeuropa PaedForm is March 31, 2023. The PaedF Working Party has produced its sixth monograph.
