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.
The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories:
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Quality Guidelines
Stability Q1A – Q1F
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Q1A(R2)
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Stability Testing of New Drug Substances and Products
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Q1B
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Stability Testing: Photostability Testing of New Drug Substances and Products
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Q1C
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Q1D
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Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
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Q1E
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Evaluation of Stability Data
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Q1F
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Stability Data Package for Registration Applications in Climatic Zones III and IV
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Analytical Validation Q2
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Q2(R1)Validation of Analytical Procedures: Text and Methodology
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Impurities Q3A – Q3D
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Q3A(R2)
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Impurities in New Drug Substances
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Q3B(R2)
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Impurities in New Drug Products
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Q3C(R5)
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Impurities: Guideline for Residual Solvents
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Q3D
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Impurities: Guideline for Metal Impurities
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Pharmacopoeias Q4 – Q4B
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Q4
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Pharmacopoeias
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Q4A
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Pharmacopoeial Harmonisation
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Q4BE
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Valuation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
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Quality of Biotechnological Products Q5A – Q5E
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Q5A(R1)
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Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
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Q5B
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Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
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Q5C
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Stability Testing of Biotechnological/Biological Products
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Q5D
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Derivation and Characterisation of Cell Substrates Used for Pr
oduction of Biotechnological/Biological Products |
Q5E
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Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
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Specifications Q6A- Q6B
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Q6A
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Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
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Q6B
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Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
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Good Manufacturing Practice Q7
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Q7
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Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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Pharmaceutical Development Q8
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Q8(R2)
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Pharmaceutical Development
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Quality Risk Management Q9
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Q9
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Quality Risk Management
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Pharmaceutical Quality System Q10
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Q10
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Pharmaceutical Quality System
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Development and Manufacture of Drug Substances Q11
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Q11
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Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
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Safety Guidelines
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Efficacy Guidelines
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Multidisciplinary Guidelines
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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