ICH guidlines Overview ICH recommendations Quality medicines

1. MULTIDICIPILINARY
EFFICACY
SAFETY
QUALTITY
PHARMA
BABA
VIKKIII
ICH:-
International Council for
Harmonisation
INTRODUCTION
- BY PHARMA BABA VIKKIII 1

2. PHARMA
BABA
INTRODUCTION
 The International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) is
unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical
aspects of pharmaceuticals and develop ICH guidelines.
 Inception in 1990.
 ICH's mission is to achieve greater harmonisation worldwide
to ensure that safe, effective and high quality medicines are
developed, and registered and maintained in the most resource
efficient manner whilst meeting high standards.
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3. PHARMA
BABA
INTRODUCTION
 ICH GUIDELINES (Q S E M)
Q Quality for e. g. 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.
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S Safety 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.

4. PHARMA
BABA
INTRODUCTION
 ICH GUIDELINES (Q S E M)
E Efficacy 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.
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M Multidisciplinary 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).

5. PHARMA
BABA
 Stability Q1A-Q1F
 Analytical Validation Q2
 Impurities Q3A-Q3E
 Pharmacopoeias Q4A-Q4B
 Quality of Biotechnological Products Q5A-Q5B
 Specifications Q6A-Q6B
 Good Manufacturing Practice Q7
 Pharmaceutical Development Q8
 Quality Risk Management Q9
 Pharmaceutical Quality System Q10
 Development and Manufacture of Drug substances Q11
 Life cycle management Q12
 Continuous manufacturing of Drug substances and Drug products Q13
 Analytical procedure development Q14
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Quality
Guidelines

6. PHARMA
BABA  Carcinogenicity Studies S1A-S1C
 Genotoxicity Studies S2
 Toxicokinetics and Pharmacokinetics S3A-S3B
 Toxicity Testing S4
 Reprodutive Toxicology S5A
 Biotechnological Products S6
 Pharmacology Studies S7A-S7B
 Immunotoxicology Studies S8
 Nonclinical evaluation for anticancer pharmaceuticals S9
 Photosafety evaluation S10
 Nonclinical peadiatric safety S11
 Non-clinical biodistribution considerations for gene therapy products
S12
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Safety
Guidelines

7. PHARMA
BABA
 Clinical safety for drugs used in long-term treatment E1
 Pharmacovigilance E2A-E2F
 Clinical study reports E3
 Dose-response studies E4
 Ethnic factors E5
 Good clinical practice E6
 Clinical trials in geriatric population E7
 General considerations for clinical trials E8
 Statistical principals for clinical trials E9
 Choice of control group in clinical trials E10
 Clinical trials in pediatric population E11-E11A
 Clinical evaluation by therapeutic category E12
 Clinical evaluation of QT E14
 Definitions in Pharmacogenetics / Pharmacogenomics E15
 Qualification of genomic biomarkers E16
 Multi-Regional clinical trials E17
 Genomic sampling E18
 Safety data collection E19
 Adaptive clinical trials E20
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Efficacy
Guidelines

8. PHARMA
BABA  MedDRA terminology M1
 Electronic standards M2
 Nonclinical safety studies M3
 Common technical document M4
 Data elements and standards for drug dictionaries M5
 Gene therapy M6
 Mutagenic impurities M7
 Electronic common technical document (eCTD) M8
 Biopharmaceutics classification system based biowaviers M9
 Bioanalytical method validation and study sample analysis M10
 Clinical electronic structured harmonized protocol (CeSHarP) M11
 Drug interaction studies M12
 Bioequivalence for Immediate-Release Solid Oral Dosage Forms M13
 Use of real-world data in pharmacological studies M14
8
Multidisciplinary
Guidelines

9. PHARMA
BABA
THANKS
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