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ICH-Guidelines of ICH-Q,S,E,M
Presented By- Anurag Kumar Kaushal
M.Pharm 1st
year
(Pharmaceutics)
CONTENT-
 Introduction
 Origin
 Benefits
 Members of ICH
 Organization of ICH
 Steps involve in ICH procedure
 ICH Guidelines
 Conclusion
 Reference
Introduction:
 The International confrence on harmonization (ICH) of technical requirements
for the regestration of Pharmaceuticals for human use.To assure safety, quality
and efficacy of medicines.
 The members of ICH include members from drug regulatory authorities and
research based industries of the European Union, the US and Japan will discuss on
the technical procedures and documents required.
 It is a unique project that brings together the regulatory authorities and
pharmaceutical industry of Europe, Japan and the US to discuss scientific and
technical aspect of drug registration
Origin:
 Harmonization of regulatory requirements was pioneered by the European
Community (EC), in the 1980s.
 The success achieved in Europe demonstrated that harmonization was feasible.
 The birth of ICH took place at a meeting in April 1990.
 Representatives of the regulatory agencies and industry associations of Europe,
Japan and the US met, primarily, to plan an International Conference.
 Topics selected for harmonization would be divided into safety, quality and efficacy
to reflect the three criteria which are the basis for approving and authorising new
medicinal products.
Benefits:
 Harmonization is beneficial for both regulatory authorities and the pharmaceutical
industry for the protection of public health.
Following are some benefits-
 It reduces the regestration cost.
 It promote public health.
 It prevent the duplication of clinical trials in human.
 It promotes international harmonization by bringing together representatives from
the three ICH region EUROPE , JAPAN and the US.
 It makes available information on ICH,ICH activity and ICH guidelines to any
country.
Members of ICH:
 In Japan, the members are the Ministry of Health, Labour and Wellan (MHLW), and
the Japan Pharmaceutical Manufacturers Association (IPMA In Europe, the
members are the European Union (EU), and the Europese Federation of
Pharmaceutical Industries and Associations (EFPIA).
 In the USA, the members are the Food and Drug Administration (FDA), ang the
Pharmaceutical Research and Manufacturers of America (PhRMA).
 Additional members include observers from the World Health Organization
(WHO), European Free Trade Association (EFTA), Canada..
Organization of ICH:
Steps of ICH procedure:
ICH guidelines:
 ICH guidelines have been adopted as a law in several countries, they are only used
as guidence for the US Food and Drug Administration.
 ICH guidelines are of four types:-
 Quality guidelines(Q)
 Safety guidelines(S)
 Efficacy guidelines(E)
 Multidisciplinary guidelines(M)
Quality guidelines
 Harmonization achievements in the quality area include pivot 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.
 Quality guidelines:-
Q1a-Q1f Stability studies
Q1a Stablity testing of new drug substance and products.
Q1b Photostability testing of new drug substances and products.
Q1c Stability testing of new dosage forms.
Q1d Bracketing and matrixing designs for stability testing of new
drug substance and products.
Q1e Evaluation of stability data.
Q1f Stability data packages for registration in climatic zone 123 and
4
Q2a Validation of analytical procedure
Q2b Methodology
Q3a-Q3d Impurities
Q3a Impurity testing in new drug substances
Q3b Impurities in dosage form
Q3c Impurities in residual solvent
Q3d Guidelines for metal impurities
Q4 Pharmacopoieal harmonization
Q5a-Q5d Quality for biotechnology products
Q5a Viral safety evaluation
Q5b Genetic stability
Q5c Stability of biotechnology products
Q5d Stability of cell substance
Q6 Specification for new drug substances and product
Q7 Good manufacturing practices
Q8 Pharmaceutical development
Q9 Quality risk management
Q10 Pharmaceutical quality system
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.
 Safety quidelines:
 S1A-S1C: Carcinogenicity Studies
 S2: Genotoxicity Studies
 S3A-S3B: Toxicokinetics and Pharmacokinetics
 S4: Toxicity Testing
 S5: Reproductive Toxicology
 S6: Biotechnological Products
 S7A-S7B: Pharmacology Studies
 S8: Immunotoxicology Studies
 S9: Nonclinical Evaluation for Anticancer Pharmaceuticals
 S10: Photosafety Evaluation
 S11: Nonclinical Pediatric Safety
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.
 Efficacy guidelines:
 E1: Clinical Safety for Drugs used in Long-Term Treatment
 E2A-E2F: Pharmacovigilance
 E3: Clinical Study Reports
 E4: Dose-Response Studies
 E5: Ethnic Factors
 E6: Good Clinical Practice
 E7 :Clinical Trials in Geriatric Population
 E8: General Considerations for Clinical Trials
 E9 :Statistical Principles for Clinical Trials
 E10: Choice of Control Group in Clinical Trials
 En-EnA: Clinical Trials in Pediatric Population
 E12 :Clinical Evaluation by Therapeutic Category
 E14 :Clinical Evaluation of QT
 E15 :Definitions in Pharmacogenetics / Pharmacogenomics
 E17: Multi-Regional Clinical Trials
 E18: Genomic Sampling
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).
 Multidisciplinary guidelines:
 M2(R2)- Electronic transmission of individual case safety reports message
specification
 M3(R3)- Guidance on non-clinical safety studies for the conduct of human clinical
trials and marketing authorization for pharmaceuticals
 M4 - Organization of the common technical document for the registration of
pharmaceutical for human use .
 M4e(R1)- The common technical document for the registration of pharmaceuticals
for human use: Efficacy
 M4q(R1)- The common technical document for the registration of pharmaceuticals
for human use: Quality
 M4s(R2)-: The common technical document for the registration of pharmaceuticals
for human use :Safety.
 M5- Data elements and standards for drug dictionaries
Conclusion
 ICH guidelines serve as indispensable frameworks for ensuring the quality, safety,
and efficacy of pharmaceutical products worldwide
THANK YOU

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ICH GUIDELINES QSEM BY Anurag Kumar kaushal

  • 1. ICH-Guidelines of ICH-Q,S,E,M Presented By- Anurag Kumar Kaushal M.Pharm 1st year (Pharmaceutics)
  • 2. CONTENT-  Introduction  Origin  Benefits  Members of ICH  Organization of ICH  Steps involve in ICH procedure  ICH Guidelines  Conclusion  Reference
  • 3. Introduction:  The International confrence on harmonization (ICH) of technical requirements for the regestration of Pharmaceuticals for human use.To assure safety, quality and efficacy of medicines.  The members of ICH include members from drug regulatory authorities and research based industries of the European Union, the US and Japan will discuss on the technical procedures and documents required.  It is a unique project that brings together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspect of drug registration
  • 4. Origin:  Harmonization of regulatory requirements was pioneered by the European Community (EC), in the 1980s.  The success achieved in Europe demonstrated that harmonization was feasible.  The birth of ICH took place at a meeting in April 1990.  Representatives of the regulatory agencies and industry associations of Europe, Japan and the US met, primarily, to plan an International Conference.  Topics selected for harmonization would be divided into safety, quality and efficacy to reflect the three criteria which are the basis for approving and authorising new medicinal products.
  • 5. Benefits:  Harmonization is beneficial for both regulatory authorities and the pharmaceutical industry for the protection of public health. Following are some benefits-  It reduces the regestration cost.  It promote public health.  It prevent the duplication of clinical trials in human.  It promotes international harmonization by bringing together representatives from the three ICH region EUROPE , JAPAN and the US.  It makes available information on ICH,ICH activity and ICH guidelines to any country.
  • 6. Members of ICH:  In Japan, the members are the Ministry of Health, Labour and Wellan (MHLW), and the Japan Pharmaceutical Manufacturers Association (IPMA In Europe, the members are the European Union (EU), and the Europese Federation of Pharmaceutical Industries and Associations (EFPIA).  In the USA, the members are the Food and Drug Administration (FDA), ang the Pharmaceutical Research and Manufacturers of America (PhRMA).  Additional members include observers from the World Health Organization (WHO), European Free Trade Association (EFTA), Canada..
  • 8. Steps of ICH procedure:
  • 9. ICH guidelines:  ICH guidelines have been adopted as a law in several countries, they are only used as guidence for the US Food and Drug Administration.  ICH guidelines are of four types:-  Quality guidelines(Q)  Safety guidelines(S)  Efficacy guidelines(E)  Multidisciplinary guidelines(M)
  • 10. Quality guidelines  Harmonization achievements in the quality area include pivot 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.  Quality guidelines:- Q1a-Q1f Stability studies Q1a Stablity testing of new drug substance and products. Q1b Photostability testing of new drug substances and products. Q1c Stability testing of new dosage forms. Q1d Bracketing and matrixing designs for stability testing of new drug substance and products. Q1e Evaluation of stability data. Q1f Stability data packages for registration in climatic zone 123 and 4
  • 11. Q2a Validation of analytical procedure Q2b Methodology Q3a-Q3d Impurities Q3a Impurity testing in new drug substances Q3b Impurities in dosage form Q3c Impurities in residual solvent Q3d Guidelines for metal impurities Q4 Pharmacopoieal harmonization Q5a-Q5d Quality for biotechnology products Q5a Viral safety evaluation Q5b Genetic stability Q5c Stability of biotechnology products Q5d Stability of cell substance Q6 Specification for new drug substances and product Q7 Good manufacturing practices Q8 Pharmaceutical development Q9 Quality risk management Q10 Pharmaceutical quality system
  • 12. 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.  Safety quidelines:  S1A-S1C: Carcinogenicity Studies  S2: Genotoxicity Studies  S3A-S3B: Toxicokinetics and Pharmacokinetics  S4: Toxicity Testing  S5: Reproductive Toxicology  S6: Biotechnological Products
  • 13.  S7A-S7B: Pharmacology Studies  S8: Immunotoxicology Studies  S9: Nonclinical Evaluation for Anticancer Pharmaceuticals  S10: Photosafety Evaluation  S11: Nonclinical Pediatric Safety
  • 14. 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.  Efficacy guidelines:  E1: Clinical Safety for Drugs used in Long-Term Treatment  E2A-E2F: Pharmacovigilance  E3: Clinical Study Reports  E4: Dose-Response Studies  E5: Ethnic Factors  E6: Good Clinical Practice
  • 15.  E7 :Clinical Trials in Geriatric Population  E8: General Considerations for Clinical Trials  E9 :Statistical Principles for Clinical Trials  E10: Choice of Control Group in Clinical Trials  En-EnA: Clinical Trials in Pediatric Population  E12 :Clinical Evaluation by Therapeutic Category  E14 :Clinical Evaluation of QT  E15 :Definitions in Pharmacogenetics / Pharmacogenomics  E17: Multi-Regional Clinical Trials  E18: Genomic Sampling
  • 16. 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).  Multidisciplinary guidelines:  M2(R2)- Electronic transmission of individual case safety reports message specification  M3(R3)- Guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals  M4 - Organization of the common technical document for the registration of pharmaceutical for human use .
  • 17.  M4e(R1)- The common technical document for the registration of pharmaceuticals for human use: Efficacy  M4q(R1)- The common technical document for the registration of pharmaceuticals for human use: Quality  M4s(R2)-: The common technical document for the registration of pharmaceuticals for human use :Safety.  M5- Data elements and standards for drug dictionaries
  • 18. Conclusion  ICH guidelines serve as indispensable frameworks for ensuring the quality, safety, and efficacy of pharmaceutical products worldwide