Monday, November 5, 2012

Brief Introduction Of ICH Guidelines

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration. Harmonisation would lead to a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health.

1. What is the purpose of ICH?
The objective of ICH is to increase international harmonisation of technical requirements to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost-effective manner. These activities have been undertaken to promote public health, prevent unnecessary duplication of clinical trials in humans, and minimize the use of animal testing without compromising safety and effectiveness.

2. What does ICH stand for?
The complete name of ICH is the "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use".

3. What is ICH?
ICH is a joint initiative involving both regulators and research-based industry representatives of the European Union, Japan and the USA in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines.

4. Which Drug Regulatory Authorities have implemented ICH Guidelines?
In addition to the Drug Regulatory Authorities (DRAs) of Europe, Japan and the US, many other DRAs worldwide have chosen to implement some or all of the ICH Guidelines in their regulations. For further information it is suggested to contact individual DRAs.

5. How can I get news on new ICH Guidelines?
You can register for the RSS feed on the ICH website to receive a notice everytime a new Guideline is added or modified on the website. Also, on the home page of the ICH website, you can refer to the news section which will inform you of any new Guideline published.

The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories:

  • Quality Guidelines

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

Exclusive example of all quality guidelines:

Stability Q1A - Q1F
Stability Testing of New Drug Substances and Products
Stability Testing: Photostability Testing of New Drug Substances and Products
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Evaluation of Stability Data
Stability Data Package for Registration Applications in Climatic Zones III and IV
Analytical Validation Q2

Q2(R1)Validation of Analytical Procedures: Text and Methodology
Impurities Q3A - Q3D
Impurities in New Drug Substances
Impurities in New Drug Products
Impurities: Guideline for Residual Solvents
Impurities: Guideline for Metal Impurities
Pharmacopoeias Q4 - Q4B
Pharmacopoeial Harmonisation
Valuation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Quality of Biotechnological Products Q5A - Q5E
Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Stability Testing of Biotechnological/Biological Products
Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products
Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
Specifications Q6A- Q6B
Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Good Manufacturing Practice Q7
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Pharmaceutical Development Q8
Pharmaceutical Development
Quality Risk Management Q9
Quality Risk Management
Pharmaceutical Quality System Q10
Pharmaceutical Quality System
Development and Manufacture of Drug Substances Q11
Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

  • Safety Guidelines

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 for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.
  • Efficacy Guidelines

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 derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines.
  • Multidisciplinary Guidelines

Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

 1. ICH Official web site, page access on 06 November 2012, 14.00 hrs
 2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, page access on 06 November 2012, 13.00 hrs


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