Development and Registration of New Drugs: An Introduction

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Establishment Registration and Product Listings

Regulatory affairs Introduction June 14 2. Two types of preclinical research End Part 1 Part 2 Registration and product life cycle Nick Deschacht Drug development Happy endings? Drug product registration Happy endings? In summary, all medicines must meet three criteria 1. Quality 2.

Welcome to the ICH official website

Safety 3. ICH has produced a comprehensive set of safety guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials.

It also covers novel types of medicines Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. MedDRA is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans.

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Your contribution will be considered by ICH for the following documents currently under consultation:. Draft Guidelines.

How drugs are discovered and developed

GCP Renovation. Contact Log In. Share this page using your social media account. Welcome to the ICH official website 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 drug registration.


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Discover ICH Products. View All Quality Guidelines. View All Safety Guidelines. View All Efficacy Guidelines. View All Multidisciplinary Guidelines. ICH Legal Mentions.