Tuesday, 27 September, 2022

INTERNATIONAL CONFERENCE ON HARMONISATION (ICH)


Introduction

ICH refers to International Conference on Harmonisation of Technical requirements of pharmaceuticals for human use. 
ICH was established in 1990 as joint regulatory/industry project to improve, through harmonisation, the efficiency of the process for developing and registering new medicinal products in 3 regions, viz., Europe, Japan and the United states, in order to make these products available to patients with a minimum of delay. 
The purpose is to make recommendation on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for products registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.

Objectives of the Organisation are:

  • To harmonize the legislative and technical requirements.
  • Mutual acceptability of data among these 3 regions.
  • Reducing cost of duplication of research work in meeting regulatory requirements (economical use of human, animals and materials resources).
  • Reducing the timelines in the global development and availability of new medicines after marketing approvals.
  • Maintain safeguards on quality, safety, efficacy and regulatory obligations to protect public health. 

Organization of ICH

The ICH is composed by 6 parties directly involved, 3 observes and IFPMA (International Federation of Pharmaceutical Manufacturers Association).
The 6 parties (voting members) are the founder member of ICH which represent the 3 regulatory bodies and 3 research-based industry in the European union, Japan and the USA. The 3 regulatory bodies are European Union (EU), Ministry of Health, Labour and Welfare, Japan (MHLW) and United States Food and Drugs Administration (USFDA). The 3 research based industry organization are European Federation of Pharmaceutical Industries and Association (EFPIA), Japan Pharmaceutical Manufacturers Association (JPMA) and Pharmaceutical Research and manufacturers of America (PhRMA).

The 5 Steps in the Development and Implementation of ICH guidelines:

Step 1. Building scientific consensus.
Step 2. Agreeing on draft text.
Step 3. Consulting regional regulatory agencies.
Step 4. Adopting harmonized guidelines.
Step 5. Implementing guidelines in ICH regions.

ICH Guidelines:

The following are the guidelines developed in 4 area:

TOPIC                 DOCUMENT CODE
1.   Quality          :           Q1 to Q10
2.   Safety            :           S1 to S9
3.   Efficacy         :           E1 TO E15
4.   Multidisciplinary  :    M1 to M4

QUALITY

Document                                           TitleQ1A(R2) : Stability testing of new drug substances and products 
Q1B : Stability testing: Photostability  testing of new drug substances and products
Q1C : Stability testing for new dosage forms
Q1D : Bracketing and matrixing design for stability testing of new drug substances and products
Q1E : Evalution for stability data 
Q2(R1) : Validation of analytical procedures: Text and Methodology
Q3A(R2) : Impurities in new drug Substances
Q3B(R2) : Impurities in new drug products 
Q3C(R4) : Impurities: Guideline for residual solvents 
Q4B : Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions
Q5A(R1) : Viral safety evaluation of biotechnology products derived from cell lines of human or animal orgin
Q5B : Quality of biotechnological products: analysis of the expression construct in cell used for production of r-DNA derived protein products
Q5C : Quality of biotechnological products: Stability testing of biotechnological/biological products 
Q5D : Derivation and characterisation of cell substrates used for production of biotechnological/biological products
Q5E : Comparability of biotechnological/biological products subject to changes in their manufacturing process
Q6A : Specifications: test procedures and acceptance criteria for new drug substances and new drug products : Chemical substances  
Q6B : Specifications: test procedures and acceptance criteria for biotechnological/biological products 
Q7 : Good manufacturing practice guide for active pharmaceutical ingredients
Q8(R1) : Pharmaceutical development
Q9 : Quality risk Management 
Q10 : Pharmaceutical quality system

SAFETY

Document                                           TitleS1A : Guideline on need for Carcinogenicity studies of pharmaceuticals
S1B : Testing for Carcinogenicity of pharmaceuticalsS1C(R2) : Dose selection for Carcinogenicity studies of Pharmaceuticals
S2A : Guidance on specific aspects of regulatory Genotoxicity tests for Pharmaceuticals
S2B : Genotoxicity: A standard battery for Genotoxicity testing of Pharmaceuticals
S3A : Note for guidance on Toxicokintics: The assessment of systemic exposure in toxicity studies
S3B : Pharmacokinetics: Guidance for repeated dose tissue distribution studies
S4 : Duration of chronic toxicity testing in animals (Rodent and non Rodent Toxicity testing)
S5(R2) : Detection of toxicity to reproduction for medicinal products and toxicity to male fertility
S6 : Preclinical  safety evaluation of biotechnology – derived pharmaceuticals
S7A : Safety pharmacology studies for human pharmaceuticalsS7B : The non – clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals
S8 : Immunotoxicity studies for human pharmaceuticals
S9 : Nonclinical evaluation for anticancer pharmaceuticals 

EFFICACY

Document                                           TitleE1 : The extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening condition
E2A : Clinical safety data management and standard for expedited reporting 
E2B(R2) : Clinical safety data management: Data elements for transmission of individual case safety reports
E2C(R1) : Clinical safety data management: periodic safety update reports for marketed drugs
E2D : Post-Approval safety data management: Definition and standards for expedited reporting 
E2E : Pharmacovigilance  Planning 
E3 : Structure and content of clinical study reports 
E4 : Dose-response information to support drug registration
E5(R1) : Ethnic factors in the acceptability of foreign clinical data
E6(R1) : Good clinical practice: Consolidated guideline
E7 : studies in support of special populations: Geriatrics
E8 : General considerations for clinical trials
E9 : Statistical principles for clinical trials 
E10 : Choice of control group and related issues in clinical trials 
E11 : Clinical investigation of medicinal products in the pediatric population
E12 : Principles for clinical evaluation of new antipertensive drugs
E14 : The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
E15 : Definition for genomic Biomarkers, Pharmacogenomics, Pharmacogentics, Genomic Data and sample coding categories
E16 : Genomic Biomakers related to drug response: context, structure and format of qulification submission

MULTIDISCIPLINARY 

Document                                           TitleM2 ICSR(R2) : Electronic transmission of individual case safety reports message specification (ICH ICSR DTD version 2.1) companion document to E2B(R3)
M3(R1) : Maintenance of the ICH guideline on Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals
M4 : Organistion of the common technical document for the registration of pharmaceutical for human use
M4Q : The common technical document for the registration of pharmaceuticals for human use: Quality   
M4S : The common technical document for the registration of pharmaceuticals for human use: Safety 
M4E : The common technical document for the registration of pharmaceuticals for human use: Efficacy

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