1. InEtUe rGnCaPti onal Conference on
Harmonization (ICH)
Consolidated Guidelines
Pravin Cumar
Head Academics

2. EU GCP
What is ICH?
Need to harmonies
Purpose of harmonization
Initiation of ICH
Objectives of ICH
The Structure of ICH
The process of Harmonization
ICH Guidelines – Q, S, E & M
ICH & the Future
The Impact of ICH

3. EU GCP
ICH is a unique joint initiative
involving both regulators and
industry as equal partners in the
scientific and technical
discussions of the testing
procedures which are required to
ensure and assess the safety,
quality and efficacy of medicines.

4. EU GCP
Awareness on critical evaluation of
medicinal products before market release
Medical tragedies
1960-70s:
Rapid increase in laws, regulations & guidelines
on medicinal products
Globalization of Pharmaceutical industry
But regulation of medicine remained as a
national responsibility

5. EU GCP
These changes lead to:
Duplication of work
Raising cost of health care
Escalation of R&D costs
Delay in drug development

6. EU GCP
The purpose is to make
recommendations on ways to achieve
greater harmonization in the
interpretation
Application of technical guidelines
Requirements for product registration in
order to reduce or obviate the need to
duplicate the testing carried out during
the research and development of new
medicines.

7. EU GCP
Aim to produce a single set of technical
requirements for the registration of new
drug, drug products to streamline
development.
Reduce or obviate duplicate testing
More economical use of human, animal and
material resources.
Eliminate unnecessary delays in the
availability of new medicines.

8. EU GCP
Availability of new medicines whilst
maintaining safeguards on quality, safety
and efficacy, and regulatory obligations to
protect public health.
To provide a unified standard for the
European Union (EU), Japan & United
States to facilitate mutual acceptance of
clinical data by the regulatory authorities
in these jurisdictions


9. EU GCP
Member:
Steering committee (SC):
ICH Parties - 6
ICH – Coordinators (One from each party)
Observers - 3 (non-voting)
IFPMA: Secretariat
Expert Working Groups (EWGs)

10. EU GCP
Expert working group: The SC is
advised on technical issues concerned
with harmonization topics by Expert
Working Groups.
They are nominated from the 6 Co –
Sponsors.

11. EU GCP
 Participants
Six Parties: EU, EFPIA, FDA,
MHLW, JPMA, PhRMA,
Three Observers: WHO, EFTA, CanadaEuropean
 Commission - European Union (EU)
 European Federation of Pharmaceutical Industries
and Associations (EFPIA)
 US Food and Drug Administration (FDA)
 Pharmaceutical Research and Manufacturers of
America (PhRMA)
 Ministry of Health, Labor and Welfare, Japan (MHLW)
 Japan Pharmaceutical Manufacturers Association
(JPMA)

12. EU GCP
STEERING COMMITTEE:
 Oversees the preparation for ICH and
the harmonization initiatives under
taken under the ICH Process.
 2 members from each of the 6 co-sponsors
 Determines policies & procedures
 Selects topics for harmonization
 Monitors progress of harmonization
initiatives

13. EU GCP
 Five-step approach
 Step 1: Consensus building
 Step 2: Confirmation of six-party harmonised
and consensus text released
 Step 3: Regulatory Consultation and
Discussion outside the ICH
 Step 4: Adoption of an ICH Harmonized
Guideline
 Step 5: Implementation

14. EU GCP
Quality (Q)
- chemical & pharmaceutical QA
Safety (S)
dealing with in vitro & in vivo pre clinical
testing
Efficacy (E)
clinical studies in human beings
Multidisciplinary (M)
Terminology
Electronic Standards
Common Documents

15. EU GCP
Q 1(A-F): Stability - Photostability
Q 2: Analytical Validation
Q 3(A-C): Impurities
Q 5(A-E): Biotechnological Quality
Q 6(A,B): Specifications
Q 7: GMP for active pharma ingredients
Q 8: Pharmaceutical development
Q 9: Quality risk management
Q10: Pharmaceutical Quality System

16. EU GCP
S1: Carcinogenicity studies – Need,
Testing, Dose Selection
S2: Genotoxicity – Regulatory, Battery of Tests
S3A: Toxicokinetics
S3B: Pharmacokinetics
S4: Chronic Toxicity Testing
S5A: Toxicity to Reproduction
S5B: Toxicity to Male Fertility
S6: Preclinical Biotech derived drugs
S7A: Safety Pharmacology
S7B: QT interval prolongation
S8: Immunotoxicity for Human Pharmaceuticals
S9 : Nonclinical Evaluation for Anticancer Pharmaceuticals

17. EU GCP
E 1: Exposure to assess clinical safety
E 2: Clinical Safety Data Management
E 3: Study Reports
E 4: Dose Response Studies
E 5: Ethnic Factors
E 6: Good Clinical Practice (GCP)
E 7: Special Populations – Geriatrics
E 8: Clinical Trials Design
E 9: Statistical Considerations

18. EU GCP
E 10: Choice of Control Group
E 11: Special Populations – Children
E 12: Therapeutic categories
E 14: The clinical evaluation of QT/QC interval prolongation &
pro arrhythmic potential for non antiarrhythmic drugs
E15: Definitions for Genomic Biomarkers,
Pharmacogenomics, Pharmacogenetics, Genomic Data
& Sample Coding Categories
E16: Genomic Biomarkers Related to Drug Response:
Context, Structure and Format of Qualification
Submissions

19. EU GCP
M1: Medical Terminology
M2: Electronic Standards for Transfer of
Regulatory Information & Data (ESTRI)
M3: Maintenance of ICH guidelines for nonclinical
safety studies
M4: Common Technical Document (CTD)
M5: Data Elements and Standards for Drug
Dictionaries

20. EU GCP
IMPACT :
Enhanced patient safety
Streamline development programs
Common quality standard
Reduce resource requirements
Forum for Communication
Opportunity for Industry & Regulators to sit across
the table
Discuss drug development procedure with a
common goal of identifying best scientific
practice and applying the same uniformly across
the globe

21. FDA & CFR

22. US FOOD & DRUG ADMINISTRATION
 The Food and Drug Administration is one of
the nation's oldest and most respected
consumer protection agencies.
www.fda.gov

23. FDA's mission
 FDA's mission is:
 To promote and protect the public health by
helping safe and effective products reach the
market in a timely way,
 To monitor products for continued safety after
they are in use, and
 To help the public get the accurate, science-based
information needed to improve health.

24. Overview
 At the heart of all FDA's regulatory activities is a
judgment about whether a new product's benefits to
users will outweigh its risks.
 Science-based, efficient risk management allows the
agency to provide the most health promotion and
protection at the least cost to the public.
 No regulated product is totally risk-free, so these
judgments are important. FDA will allow a product
to present more of a risk when its potential benefit is
great -- especially for products used to treat serious,
life-threatening conditions.

25. FDA Departments
FDA is an agency within the Department of
Health and Human Services and consists of 9
centers/offices.
 Center for Biologics Evaluation and Research
(CBER)
 Center for Devices and Radiological Health
(CDRH)
 Center for Drug Evaluation and Research
(CDER)

26. Contd…
 Center for Food Safety and Applied Nutrition
(CFSAN)
 Center for Veterinary Medicine (CVM)
 National Center for Toxicological Research
(NCTR)
 Office of Chief Counsel
 Office of the Commissioner (OC)
 Office of Regulatory Affairs (ORA)

27. CBER
 CBER's mission is to protect and enhance the public
health through the regulation of biological and related
products including blood, vaccines, allergenics, tissues,
and cellular and gene therapies.
 Biologics, in contrast to drugs that are chemically
synthesized, are derived from living sources (such as
humans, animals, and microorganisms), are not easily
identified or characterized, and many are manufactured
using biotechnology.

28. CBER
 These products often represent cutting-edge
biomedical research and, in time, may offer the
most effective means to treat a variety of
medical illnesses and conditions that presently
have few or no other treatment options.

29. CDRH
 More than 20,000 firms worldwide produce over
80,000 brands and models of medical devices for
the U.S. market, ranging from contact lenses and
blood sugar monitors to implanted hip joints and
heart valves.
 The FDA's Center for Devices and Radiological
Health (CDRH) makes sure that new medical
devices are safe and effective before they are
marketed.

30. Contd…
 Many of these devices are the first of a kind,
such as a robotic arm that can operate a variety
of surgical tools with tremendous precision.
 Other high-tech devices are designed to
prevent, diagnose or treat cancer, heart disease,
impaired vision and hearing, and other health
problems.

31. Contd….
 The center also monitors devices throughout
the product life cycle, including a nationwide
postmarket surveillance system.
 And it assures that radiation-emitting products,
such as microwave ovens, TV sets, cell phones,
and laser products meet radiation safety
standards.

32. CDER
 The FDA's Center for Drug Evaluation and
Research (CDER) promotes and protects the
health of Americans by assuring that all
prescription and over-the-counter drugs are
safe and effective.
 CDER evaluates all new drugs before they are
sold, and serves as a consumer watchdog for
the more than 10,000 drugs on the market to be
sure they continue to meet the highest
standards.

33. Contd…
 The center routinely monitors TV, radio, and
print drug ads to ensure they are truthful and
balanced.
 CDER also plays a critical role in providing
health professionals and consumers
information to use drugs appropriately and
safely.

34. CDER regulates-
 Prescription Drugs: Prescription medicines
include any drug product that requires a
doctor's authorization to purchase.
 Generic Drugs: A generic drug is a drug
product that is equivalent to brand name
products in terms of quality and performance.
 Over-the-Counter Drugs: OTC drug products
are available to consumers without a doctor's
prescription.

35. Title 21
CFR

36. Introduction
 Title 21 is the portion of the Code of Federal
Regulations that governs food and drugs within
the United States for the Food and Drug
Administration (FDA), the Drug Enforcement
Administration (DEA), and the Office of
National Drug Control Policy (ONDCP).

37.  It is divided into three chapters:
 Chapter I — Food and Drug Administration
 Chapter II — Drug Enforcement
Administration
 Chapter III — Office of National Drug Control
Policy

38. Chapter I
• Most of the Chapter I regulations are based on the
Federal Food, Drug, and Cosmetic Act.
• Notable sections:
• 11 - electronic records and electronic signature
related
• 50- Protection of human subjects in clinical trials
• 56- Institutional Review Boards that oversee clinical
trials
• 58- Good Laboratory Practices (GLP) for nonclinical
studies

39.  The 100 series are regulations pertaining to food:
 101, especially 101.9 — Nutrition facts label related
 106-107 requirements for infant formula
 110 cGMPs for food products
 170 food additives
 190 dietary supplements

40.  The 200 and 300 series are regulations
pertaining to pharmaceuticals :
 202-203 Drug advertising and marketing
 210 cGMPs for pharmaceuticals
 310 Requirements for new drugs
 328 Specific requirements for over-the-counter
(OTC) drugs.

41.  The 500 series are regulations for animal feeds
and animal medications:
 The 600 series covers biological products (e.g.
vaccines, blood):
 The 700 series includes the limited regulations
on cosmetics:
 The 800 series are for medical devices:

42.  The 900 series covers mammography quality
requirements enforced by CDRH.
 The 1000 series covers radiation emitting
device (e.g. lasers, cell phones) requirements
enforced by CDRH.
 The 1200 series consists of rules primarily
based in laws other than the Food, Drug, and
Cosmetic Act:

43. Chapter II
 1308.11 — List of Schedule I drugs
 1308.12 — List of Schedule II drugs
 1308.13 — List of Schedule III drugs
 1308.14 — List of Schedule IV drugs
 1308.15 — List of Schedule V drugs

44. Chapter III
 1405 Government wide requirements for drug-free
workplaces

45. EU GCP
THANK YOU