ICH Guidelines.ppt by Dr U .Srinivasa

Useful for B.Pharm students

1. ICH GUIDELINES FOR HERBAL DRUGS
Dr.U.Srinivasa, D.Pharm, M. Pharm., M.Phil.,
Ph.D.
Professor and Head, (Dept. of
Pharmacognosy)
Srinivas college of pharmacy, Mangalore.
Email.
[email protected]

2. ICH GUIDELINES
•ICHisthe“InternationalConferenceon
HarmonizationofTechnicalRequirementsfor
RegistrationofPharmaceuticalsforHumanUse”.
•ICHisajointinitiativeinvolvingbothregulators
andresearch-basedindustryrepresentativesof
theEU,JapanandtheUSinscientificand
technicaldiscussionsofthetestingprocedures
requiredtoassessandensurethesafety,quality
andefficacyofmedicines.

3. OBJECTIVES
•Toincreaseinternationalharmonizationoftechnical
requirementstoensurethatsafe,effectiveandhigh
qualitymedicinesaredeveloped.
•Toharmonizetechnicalrequirementsforregistrationor
marketingapproval.
•Todevelopandregisterpharmaceuticalsinthemost
efficientandcosteffectivemanner.
•Topromotepublichealth.
•Topreventunnecessaryduplicationofclinicaltrialson
humans.
•Tominimizetheuseofanimaltestingwithout
compromisingsafetyandeffectivenessofdrug.

4. TOPICS
•Four Broad Categories -QSEM
•Quality(Q):Thoserelatingtochemicaland
pharmaceuticalQualityAssurance(StabilityTesting,
ImpurityTesting,etc.)
•Safety(S):Thoserelatingtoinvitroandinvivopre-
clinicalstudies(CarcinogenicityTesting,Genotoxicity
Testing,etc.)
•Efficacy(E):Thoserelatingtoclinicalstudiesin
humansubject(DoseResponseStudies,Good
ClinicalPractices,etc.)
•Multidisciplinary(M):Cross-cuttingTopicswhichdo
notfituniquelyintooneoftheabovecategories
(MedDRA,ESTRI,M3,CTD,M5)

5. •QUALITY
•Q1A(R2): STABILITY TESTING OF NEW DRUGS AND
PRODUCTS
•Q1B: PHOTOSTABILITY TESTING
•Q1C : STABILITYTESTING OF NEW DOSAGE FORMS
•Q1D: BRACKETING AND MATRIXING DESIGNS FOR
STABILITY TESTING OF DRUG SUBSTANCES AND
DRUG PRODUCTS.
•Q1E: EVALUATION OF STABILITY DATA
•Q1F: STABILITY DATA PACKAGE FOR REGISTRATION
IN CLIMATIC ZONES III AND IV

6. ASSURANCE
•Q2A: DEFINTIONS AND TERMINOLOGY: ANALYTICAL
VALIDATION
•Q2B: METHODOLOGY
•Q3A(R2) : IMPURITIES IN NEW DRUG SUBSTANCES
•Q3B(R2) : IMPURITIES IN NEW DRUG PRODUCT
•Q3C(R3) : IMPURITIES GUIDELINES FOR RESIDUAL
SOLVENTS
•Q4: PHARMACOPOEIA
•Q4A: PHARMACOPOEIAL HARMONIZATION
•Q5A: VIRALSAFETY EVALUATION
•Q5B: GENETIC STABILITY
•Q5C: STABILITYOF BIOTECHNOLOGY PRODUCTS
•Q5D: CELLSUBSTRATES

7. •Q6A: SPECIFICATIONS, TEST PROCEDURES AND
ACCEPTANCE CRITERIAFOR NEW DRUG
SUBSTANCESAND PRODUCTS
•Q6B : SPECIFICATION TEST PROCEDURE AND
ACCEPTANCE CRITRIA FOR BIOTECHNOLOGICAL/
BIOLOGICAL PRODUCTS
•Q7A: GMPFORACTIVE
PHARMACEUTICALINGREDIENTS
•Q8: PHARMACEUTICAL DEVELOPMENT
•Q9: QUALITY RISK MANAGEMENT
•Q10: PHARMACEUTICAL QUALITY SYSTEM

8. SAFETY
•S1A: GUIDELINE ON THE NEED FOR
CARCINOGENICITY STUDIES OF
PHARMACEUTICALS
•S1B: TESTING FOR CARCINOGENICITYOF
PHARMACEUTICALS
•S1C(R2): DOSE SELECTION FOR CARCINOGENICITY
STUDIES OF PHARMACEUTICALS
•S2(R1): GUIDANCE ON GENOTOXICITY TESTING AND
DATA INTERPRETATION FOR PHARMACEUTICALS
INTENDED FOR HUMAN USE

9. •S3A:NOTEFORGUIDANCEONTOXICOKINETICS:
THEASSESSMENT OFSYSTEMICEXPOSURE IN
TOXICITYSTUDIES
•S3B:PHARMACOKINETICS :GUIDANCE FOR
REPEATEDDOSETISSUEDISTRIBUTIONSTUDIES
•S4:DURATIONOFCHRONICTOXICITYTESTING
INANIMALS(RODENTANDNONRODENTTOXICITY
TESTING)

10. •S5 (R2):DETECTION OF TOXICITYTO
REPRODUCTION FORMEDICINALPRODUCTS &
TOXICITYTOMALEFERTILITY
•S6(R1):ADDENDUM TOICH
•S6:PRECLINICAL SAFETY EVALUATION OF
BIOTECHNOLOGY -DERIVEDPHARMACEUTICALS
•S6:PRECLINICAL SAFETY EVALUATION OF
BIOTECHNOLOGY DERIVEDPHARMACEUTICALS

11. EFFICACY
•E1:THEEXTENTOFPOPULATIONEXPOSURE TO
ASSESSCLINICALSAFETY
•E2A:CLINICALSAFETYDATAMANAGEMENT
•E2B(R2):MAINTENANCE OFTHEICHGUIDELINEON
CLINICALSAFETYDATAMANAGEMENT
•E2B(R3):REVISIONOFTHEICHGUIDELINEON
CLINICALSAFETYDATAMANAGEMENT
•DATA ELEMENTS FOR TRANSMISSION OF
INDIVIDUALCASESAFETYREPORTS
•E2C(R1):CLINICALSAFETYDATAMANAGEMENT :
PERIODIC SAFETY UPDATE REPORTS FOR
MARKETEDDRUGS
•E2D:POST-APPROVALSAFETYDATAMANAGEMENT :
DEFINITIONSANDSTANDARDS FOREXPEDITED
REPORTING

12. •E2E: PHARMACOVIGILANCE PLANNING
•E2F: DEVELOPMENT SAFETY UPDATE REPORT
•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): GUIDELINE FOR GOOD CLINICAL PRACTICE
•E7: STUDIES IN SUPPORT OF SPECIAL
POPULATIONS:GERIATRICS

13. MULTIDISCIPLINARY GUIDELINES
•M1-MedDRA:MedicalTerminology
•M2-ESTRI:ElectronicStandardsfortheTransferof
RegulatoryInformation
•M3-(R2):NonclinicalSafetyStudiesfortheConductof
HumanClinicalTrialsandMarketingAuthorizationfor
Pharmaceuticals
•M4-CTD:TheCommonTechnicalDocument
•M5:DataElementsandStandardsforDrugDictionaries