The document provides guidance on several ICH guidelines related to quality, safety, efficacy and multidisciplinary topics. It summarizes key ICH guidelines including Q1A on stability testing, Q2 on analytical validation, and Q3A-Q3E on impurities. It also discusses guidelines for nonclinical safety evaluation (S1-S10), clinical safety data management (E2A, E2B, E2C, E2D), and clinical study reports (E3).

1. ICH Guidelines
INTERNATIONAL CONFERENCE FOR HARMONIZATION
2
Presented by
Rajguru Apeksha Dasharath
F.Y.M.Pharmacy ( Pharmaceutics)
Amrutvahini College Of Pharmacy,
Sangamner

2. ICH Guidelines
Q S E M
Quality Safety Efficacy Multidisciplinary
2

3. Harmonization achievements in the Quality area include pivotal
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.
3

4. Quality
Q1A – Q1F- Stability
Q2 – Analytical Validation
Q3A-Q3E – Impurities
Q4A – Q4B Pharmacopoeias
Q5A – Q5E – Quality of biotechnological ProductsQ
Q6A– Q6B – Specification
Q7 – Good manufacturing practise
Q8 – Pharmaceutical Development
Q9 – Quality Risk Management
4

5. 5
Q10 – Pharmaceutical Quality System
Q11 – Development and manufacture of drug substances
Q12 – Lifecycle Management
Q13- Continuous Manufacturing of drug substances and drug products
Q14 – Analytical procedure Development

6. Q1A: Stability testing of new drug substances and products.
The purpose of stability testing is to provide evidence on how the quality of a drug substance or
drug products varies with time under the influence of variety of environmental factors such as
temperature, humidity, light and to establish a re test period for the drug substance or a shelf
life for the drug products.
Q1B: Photostability testing of new drug substances and products.
Gives guidance on the basic testing protocol required to evaluate the light sensitivity and
stability of new drug and products.
6

7. Q1C: Stability testing for new dosage forms.
Gives guidelines for new formulations of already approved medicines and defines the
circumstances under whichreduced stability data can be accepted.
Q1D: Bracketing and matrixing designs for stability testing of new drug substances and
products.
This document is intended to address recommendation on the application of bracketing and
matrixing to stability studies conducted in accordance with principles outlined in the main
stability guideline.
7

8. 8
Q1E: Evaluation of stability data
This guideline addresses the evaluation of stability data that should be submitted in the
registration applications for new molecular entities and associated drug products. The guideline
provides recommendations on establishing shelf lives for drug substance and drug products
intended for storage at or below room temperature.
Q1F: Stability data package for registration application in climatic zone III and IV
Describes harmonised global stability testing requirements in order to facilitate access to
medicines by reducing the no of different storage conditions. WHO conducted a survey amongst
their member states to find consensus on 30 c / 65%RH as the long term storage conditions for
hot dry and hot- humid regions.

9. Q2[R1] : Validation of analytical procedures : Text and methodology
This identifies the validation parameters needed for a variety of analytical methods. It also
discusses the characteristics that must be considered during the validation of the analytical
procedures which are included as part of registration applications.
Q2(R2)Q14EWG Analytical procedure development and revision of Q2(R1) Analytical validation
Q2(R1) Revision
The scope of the revision of ICH Q2(R1) will include validation principles that cover analytical use
of spectroscopic or spectrometry data (e.g., NIR, Raman, NMR or MS) some of which often
require multivariate statistical analyses.
9
Q2: Analytical validation

10. Q3A(R2) Impurities in new drug substances
The Guideline addresses the chemistry and safety aspects of impurities, including the listing of
impurities in specifications and defines the thresholds for reporting, identification and
qualification.
Q3B(R2) Impurities in new drug products
It complements the Guideline on impurities in new drug substances and provides advice in
regard to impurities in products containing new, chemically synthesized drug substances. The
Guideline specifically deals with those impurities which might arise as degradation products of
the drug substance, or arising from interactions between drug substance and excipients or
components of primary packaging materials.
10

11. 11
Q3C(R6) Maintainance of the guidelines for residual solvents
his recommends the use of less toxic solvents in the manufacture of drug substances and dosage
forms, and sets pharmaceutical limits for residual solvents (organic volatile impurities) in drug
products.
Q3D(R1) Guideline for elemental impurities
ICH Q3D Elemental Impurities is a quality guideline for the control of elemental
impurities in new drug products (medicinal products), and it establishes Permitted Daily
Exposures (PDEs) for 24
Elemental Impurities (EIs) for drug products administered by the oral, parenteral and inhalation
routes of administration. In addition, guidance is provided in Q3D on how to develop an
acceptable level for EIs for drug products administered by other routes of administration.

12. Q3D(R2) Mainatainance EWG Revision of Q3D(R1) for cutaneous and transdermal products
Q3Dtraining Implementation of guideline for elemental impurities
The ICH Steering Committee considered that the development of a comprehensive training
programme and supporting documentation sponsored by ICH was necessary to ensure the
proper interpretation and effective utilisation by industry and regulators alike to enable a
Harmonised and smooth implementation of Q3D on a global basis.
Q3E Impurity: Assessment and control of extractables and leachables for pharmaceuticals and
biologics
Based on the assessment and control of extractables and leachables (E&L), and is expected
would assist both
applicants and regulators by providing focus on critical aspects, and improving transparency in
requirements for medicinal products including drug delivery device components.
12

13. 13
Q4A Pharmacopeial harmonization
The pharmacopoeial authorities, working together through the Pharmacopoeial
Discussion Group (PDG), have been closely involved with the work of ICH since the
outset and harmonisation between the major pharmacopoeias, which started before ICH,
has proceeded in parallel.
Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH
regions
Describes a process for the evaluation and recommendation by the Q4B Expert Working
Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by
regulatory authorities for use as interchangeable in the ICH regions

14. Q5A: Viral safety evaluation of biotechnology products derived from cell lines of
human or animal origin
The purpose of this Guideline is to provide a general framework for virus testing, experiments
for the assessment of viral clearance and a recommended approach for the design of viral tests
and viral clearance studies.
Q5B Anyalysis of the expression construct in cells used for production of r-DNA Derrived
protein products
This document is intended to describe the types of information that are considered valuable in
assessing the structure of the expression construct used to produce recombinant DNA derived
proteins.
14

15. Q5C Quality of biotechnological products: Stability testing of biotechnological/ biological
products
This document augments the stability guideline(Q1A) and deals with the particular aspects of
stability test procedures needed to take account of the special characteristics of products in
which the active components are typically proteins or polypeptides
Q5D Derivation and characterization of cell substracts used for production of biotechnological
/ biological products
This document provides broad guidance on appropriate standards for the derivation of human
and animal cell lines and microbial cells used to prepare biotechnological/biological products,
and for the preparation and characterisation of cell banks to be used for production.
15

16. 16
Q5E Comparability of biotechnological/ biological products subject to changes in their
manufacturing process
this Guideline is intended to assist in the collection of relevant technical information
which serves as evidence that the manufacturing process changes will not have an
adverse impact on the quality, safety and efficacy of the drug product.

17. Q6A Specification: Test procedures and acceptance criteria for new drug substance and new
drug products:Chemical substances
This document provides guidance on the setting and justification of acceptance criteria
and the selection of test procedures for new drug substances of synthetic chemical
origin, and new drug products produced from them, which have not been registered
previously in the ICH regions.
Q6B Specification: Test procedures and acceptance criteria for Biotecnological/ biological
products
This document provides general principles on the setting and justification of a uniform set
of international specifications for proteins and polypeptides which are produced from
recombinant or non-recombinant cell-culture expression systems.
17

18. 18
Good manufacturing practise guide for active pharmaceutical ingredients
This document is intended to provide guidance regarding Good Manufacturing Practice
(GMP) for the manufacturing of Active Pharmaceutical Ingredients (APIs) under an
appropriate system for managing quality. It is also intended to help ensure that APIs
meet the requirements for quality and purity that they purport or are represented to
possess.

19. The aim of pharmaceutical development is to design a quality products and its manufacturing
process to consistently deliver th intended performance of the products.
This Guideline provides principles and examples of tools for quality risk management
that can be applied to different aspects of pharmaceutical quality.
19

20. 20
This Guideline applies to the systems supporting the development and manufacture of
pharmaceutical drug substances and drug products, including biotechnology and
biological products, throughout the product lifecycle.
(chemical entities and biotechnological /biological entities)
This guideline describes approaches to developing and understanding the manufacturing
process of the drug substance.

21. 21
Q12 Technical and regulatory considerations for pharmaceutical product lifecycle
management
This new Guideline is proposed to provide a framework to facilitate the management of
post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more
predictable and efficient manner across the product lifecycle.
This guideline proposed to –
Capture key technical and regulatory consideration that promote harmonisation, including
certain Current Good Manufacturing Practices elements specific to continuous manufacturing.

22. 22
The new guideline is proposed to harmonise the scientific approaches of Analytical Procedure
Development, and to provide the principles relating to the description of Analytical Procedure
Development process. This new guideline is intended to improve regulatory communication
between industry and regulators and facilitate more efficient, sound scientific and risk-based
approval as well as post-approval change management of analytical procedures.

23. 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.
23
Safety

24. 24
S1 Carcinogenicity studies
S2 Genotoxicity studies
S3 Toxicokinetics and pharmacokinetics
S4 Toxicity testing
S5 Reproductive toxicology
S6 Biotecnological products
S7 Pharmacology studies
S8 Immunotoxicology studies
S9 Non clinical evaluation for anticancer pharmaceuticals
S10 Photosafety evaluation

25. S1A Need for carcinogenicity studies of pharmaceuticals
This provides a consistent definition of the circumstances under which it is necessary to
undertake carcinogenicity studies on new drugs
S1B Testing for carcinogenicity of pharmaceuticals
This document provides guidance on approaches for evaluating the carcinogenic
potential of pharmaceuticals.
S1C Dose selection for carcinogenicity studies of pharmaceuticals
This document addresses the criteria for the selection of the high dose to be used in
carcinogenicity studies on new therapeutic agents to harmonise current practices and
improve the design of studies
25

26. 26
S2(R1) Guidence on genotoxicity testing and data interpretation for pharmaceuticals intended
for human use
The S2A Guideline on Guidance on Specific Aspects of Regulatory Genotoxicity Tests for
Pharmaceuticals
This document provided specific guidance and recommendations for in vitro and in vivo tests
and on the evaluation of test results.
The S2B Guideline on Genotoxicity
This document addressed two fundamental areas of genotoxicity testing: the
identification of a standard set of assays to be conducted for registration, and the extent
of confirmatory experimentation in any particular genotoxicity assay in the standard
battery.

27. S3A Note for guidance on toxicokinetics: The assessment of systemic exposure in toxicity
studies
This document gives guidance on developing test strategies in toxicokinetics and highlights the
need to integrate pharmacokinetics into toxicity testing, in order to aid in the interpretation of
the toxicology findings and promote rational study design development.
S3B Pharmacokinetics : Guidence for repeated dose tissue distribution studies
This document gives guidance on circumstances when repeated dose tissue distribution studies
should be considered (e.g., when appropriate data cannot be derived from other sources). It also
gives recommendations on the conduct of such studies.
27

28. S4 Duration of chronic toxicity testing in animals (Rodent and non rodent toxicity
testing)
Rodent (study of 6 months duration)
Non rodent (a study of nine months duration)
This guidance has been prepared for the development of medicinal products with the
exception of those already covered by the ICH Guideline on Safety Studies for
Biotechnological Products, e.g., Monoclonal antibodies, recombinant DNA proteins.
S5(R3) Detection of toxicity to reproduction for human pharmaceuticals
provides human safety assurance at least equivalent to that provided by current testing
paradigms.
28

29. S6(R1) Preclinical safety evaluation of biotechnology derived pharmaceuticals
S7A Safety pharmacology studies for human pharmaceuticals
This document provides a definition, general principles and recommendations for safety
pharmacology studies
S7B The non clinical evaluation of the potential for delayed ventricular repolarization (QT
interval prolongation ) by human pharmaceuticals
This guidelines includes information concerning non clinical assaysand integrated risk
assessments.
29

30. 30
It applies to new pharmaceuticals intended for use in humans, as well as to marketed
pharmaceuticals proposed for different indications
This Guideline provides information for pharmaceuticals that are intended to treat cancer in
patients with late stage or advanced disease regardless of the route of administration, including
both small molecule and biotechnology-derived pharmaceuticals.

31. S10 Photosafety evaluation of pharmaceuticals
This Guideline provides international standards for photosafety assessment and harmonises such
assessments supporting human clinical trials and marketing authorizations for pharmaceuticals.
S11 Non clinical safety testing in support of development of pediatric medicines
Guideline provides direction on the nonclinical safety studies important to support a pediatric
development programme
It recommends standards for the conditions under which nonclinical juvenile animal testing is
considered informative and necessary to support paediatric clinical trials, and also provides
guidance on the design of the studies.
31

32. 32
S12 EWG Non clinical biodistribution studies for gene therapy products
The S12 EWG is working on the development of a new S12 Guideline on “Nonclinical
Biodistribution Considerations for Gene Therapy Products”, with a view to providing
recommendations on the elements of nonclinical studies performed that include Biodistribution
assessment, and will contribute to the streamlined development of the Gene Therapy products,
while maintaining scientific rigor and minimising the unnecessary use of animals.

33. 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.
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.
33
Efficacy

34. E1 The extent of population exposure to assess clinical safety for drugs intended for long term
treatment of non life threatening conditions
This document gives recommendations on the numbers of patients and duration of
exposure for the safety evaluation of drugs intended for the long-term treatment of non-
life-threatening conditions.
34

35. 35
E2A Clinical safety data management: Definations and standards for expedited reporting
This document gives standard definitions and terminology for key aspects of clinical safety
reporting.
It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug
reactions in the investigational phase of drug development.
E2B (R3) Clinical safety data management : Data elements for transmission of individual case
safety reports(ICSRs)
E2B(R3) Electronic transmission of individual case safety reports (ICRs)
The ICH steering committee endorsed the establishment of the IWG on E2B (R3) to progress
implementation activities and ensure transistion from E2B (R2) to E2B(R3)

36. E2C(R2) Periodic benefit-risk evaluation report
E2C(R2) Questions and answers: periodic benefits-risk evaluation report
Q & As The revision E2C(R2) to E2C has introduced new concepts and principles
linked to an evolution of the traditional PSUR from an interval safety report to cumulative
benefit-risk report and with a change in focus from individual case reports to more
aggregate data evaluation.
E2D Post-approval safety data management: definitions and standards for
expedited reporting
This document provides a standardised procedure for post-approval safety data
management and the guidance for gathering and reporting information.
36

37. 37
E3 Structure and content of clinical study reports
This document describes the format and content of a clinical study report that will be acceptable
to all regulatory authorities of the ICH regions.
E3 Q & AS Questions and answers:Structure and content of clinical study reports
(R1)
E4 Dose-Response information to support drug registration
This document gives recommendations on the design and conduct of studies to assess the
relationships among dose, drug-concentration in blood, and clinical response throughout the
clinical development of a new drug.

38. E5(R1) Ethnic factors in the acceptability of foreign clinical data
E5 Q&As Questions and answers: ) Ethnic factors in the acceptability of foreign clinical data
This document addresses the intrinsic characteristics of the drug recipient and extrinsic
characteristics associated with environment and culture that could affect the results of
clinical studies carried out in regions, and describes the concept of the "bridging study"
that a new region may request to determine whether data from another region are
applicable to its population.
GCP covers aspects of monitoring, reporting and archiving of clinical trials, and
incorporates addenda on the Essential Documents and on the Investigator's Brochure.
38

39. 39
E7 Studies in support of special populations: Geriatrics
This document provides recommendations on the special considerations, which apply in
the design and conduct of clinical trials of medicines that are likely to have significant use
in the elderly.
E7 Q&As Questions and answers: Studies in support of special populations: Geriatrics
This document sets out the general scientific principles for the conduct, performance and
control of clinical trials.

40. E9(R1) Addendum : Statistical principles for clinical trials
The Addendum provides clarification on E9 and an update on the choice of estimand in
clinical trials to describe an agreed framework for planning, conducting and interpreting
sensitivity analyses of clinical trial data.
E10 Choice of control group and related issues in clinical trials
This document addresses the choice of control groups in clinical trials considering the
ethical and inferential properties and limitations of different kinds of control groups.
40

41. 41
E11 (R1) Addendum : Clinical investigation of medical products in the pediatric population
Targeted scientific and technical issues relevant to pediatric populations, regulatory
requirements for pediatric study plans, and infrastructures for undertaking complex trials
in pediatric patient
E11A EWG Pediatric extrapolation
E12 Principles for clinical evaluation of new antihypertensive drugs
It provides a set of "Principles" on which there is general agreement among all ICH
regions covering endpoints and trial designs.

42. E14 The clinical evaluation ofQT/QTc interval prolongation and proarrhythmic potential for
non-antiarrhythmic drugs
This document provides recommendations to sponsors concerning the design, conduct,
analysis, and interpretation of clinical studies to assess the potential of a drug to delay
cardiac repolarization
This Guideline contains definitions of key terms in the discipline of pharmacogenomics
and pharmacogenetics, namely genomic biomarkers, pharmacogenomics,
pharmacogenetics and genomic data and sample coding categories
E16 Qualification of genomic biomarkers
42

43. 43
The Guideline describes recommendations regarding context, structure, and format of
regulatory submissions for qualification of genomic biomarkers
E17 General principles for planning and design of multi-regional clinical trials
This Guideline provides guidance on general principles on planning/designing Multi-
Regional Clinical Trial (MRCT).
Regulatory agencies are currently facing some challenges in evaluating data from
MRCTs for drug approval and it was deemed necessary to developed a Harmonised
international Guideline to promote conducting MRCT appropriately, especially focusing
on scientific issues in planning/designing MRCTs.

44. This document provides Harmonised principles of genomic sampling and management
of genomic data in clinical studies.
This Guideline will facilitate the implementation of genomic studies by enabling a
common understanding of critical parameters for the unbiased collection, storage, and
optimal use of genomic samples and data.
44
E18 Genomic sampling and management of genomic
data

45. E19 EWG Optimisation of safety data collection
This new Guideline is proposed to provide Harmonised guidance on when it would be
appropriate to use a targeted approach to safety data collection in some late-stage pre-
marketing or post-marketing studies, and how such an approach would be implemented.
E20 EWG Adaptive clinical trials
The E20 EWG is working on the development of a new E20 Guideline on “Adaptive
Clinical Trials” on the design, conduct, analysis, and interpretation of adaptive clinical
trials that provides a transparent and harmonized set of principles for the regulatory
review of these studies in a global drug development program. These principles should
also provide the flexibility to evaluate / discuss innovative approaches to clinical trial
design throughout the development process.
45

46. 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).
46

47. M1 MedDRA- Medical dictionary for regulatory activities
Due to the development of this topic over the years, all information about MedDRA
M1 PtC WG MedDRA points to consider
objective of facilitating international electronic communication by evaluating and
recommending, open and non-proprietary - to the extent possible - Electronic Standards
for the Transfer of Regulatory Information (ESTRI) that will meet the requirements of the
pharmaceutical companies and regulatory authorities.
47

48. 48
M3 (R2) Guidance on nonclinical safety studies for the conduct of human clinical
trials and marketing authorization for pharmaceuticals
The recommendations of this revised Guidance further harmonise the nonclinical
safety studies to support the various stages of clinical development among the ICH
regions.
M3(R2) Q& As (R2) Questions and answers: Guidance on nonclinical safety
studies for the conduct of human clinical trials and marketing authorization for
pharmaceuticals
To clarify the key issues of this document, the Steering Committee has endorsed the
establishment of a M3(R2) Implementation Working Group (IWG), with the objective of
developing the Q&As

49. The Common Technical Document was agreed upon by the Steering Committee in
November 2000.
The agreement to assemble all the Quality, Safety and Efficacy information in a
common format (called CTD - Common Technical Document ) has revolutionised the
regulatory review processes, led to harmonised electronic submission that, in turn,
enabled implementation of good review practices. For industries, it has eliminated the
need to reformat the information for submission to the different ICH regulatory
authorities.
The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3,
4 and 5 are intended to be common for all regions. In July 2003, the CTD became the
mandatory format for new drug applications in the EU and Japan, and the strongly
recommended format of choice for NDAs submitted to FDA, United States.
49

50. 50

51. the ICH Steering Committee endorsed a Concept Paper for Topic M5 and subsequently
formed the M5 EWG to develop ICH requirements for the standardisation of medicinal
product identifiers and related terminology.
M6 Virus and gene therapy vector shedding and transmission
The ICH Steering Committee endorsed the development of an ICH Guideline on this
topic with the aim of providing more extensive information to improve harmonisation
amongst the ICH regions.
51
M5 Data elements and standards for drug
dictionaries

52. 52
M7(R1) Assessment and control of DNA reactive (Mutagenic) impurities in
pharmaceuticals to limit potential carcinogenic risk
Gives guidance on analysis of Structure Activity Relationship for genotoxicity.
It is intended to resolve questions such as whether impurities with similar alerts that
potentially have similar mechanism of action should not be combined in calculating a
Threshold of Toxicological Concern (TTC) and whether the TTC may differ based on
differences in the approved duration of use.
M7 (R2) Maintaince EWG/ IWG Assessment and control of DNA Reactive
(mutagenic) Impurities in pharmaceuticals to limit potential carcinogenic risk
The M7(R2) Maintenance EWG/IWG is currently undertaking a maintenance of the
M7(R1) Guideline to incorporate acceptable limits (Acceptable Intakes (AIs) or Permitted
Daily Exposures (PDEs)) for new DNA reactive (mutagenic) impurities and revising
acceptable limits for impurities already listed in the Addendum as new data becomes
available, which will result in the future ICH M7(R2) version.

53. The ICH M8 electronic Common Technical Document (eCTD) v4.0 is maintained by the
M8 EWG/IWG.
M8 EWG/IWG Electronic common technical document (e CTD)
ICH M8 EWG was formed in November 2010 to take over the development and revision
of Ectd
The M8 EWG provides technical review and impact assessment of issues arising from
the use of the ICH M4 CTD Guidelines within the context of the eCTD.
53

54. This new multidisciplinary Guideline addresses Biopharmaceutics Classification System
(BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and
III drugs, however BCS-based biowaivers for these two classes are not recognised
worldwide. This means that pharmaceutical companies have to follow different
approaches in the different regions.
M9 Q & As Q& As on Biopharmaceutics classification system based biowaivers
The ICH M9 Q&As provide clarity to suport the implementation of the ICH M9 Gudieline
on Biopharmaceutics Classification System (BCS)-based biowaivers in ICH Regulatory
Member countries/regions.
54

55. M10 EWG Bioanalytical Method Validation
This new multidisciplinary guideline will apply to the validation of bioanalytical methods
and study sample analyses in non-clinical and clinical studies.
This guideline will provide recommendations on the scientific regulatory requirements for
bioanalysis conducted during the development of drugs of both chemical and biological
origins.
55
M10 Bioanalytical Method Validation

56. This new guideline is proposed to provide comprehensive clinical protocol organization
with standardised content, with both required and optional components. The guideline
will outline two main sets of harmonised approaches:
•a template to include identification of headers, common text and a set of data fields and
terminologies which will be the basis for efficiencies in data exchange,
•a technical specification that uses an open, non-proprietary standard to enable
electronic exchange of clinical protocol information.
56

57. Provide a consistent approach in designing, conducting, and interpreting Drug-drug
interactions studies during the development of a therapeutic product.
The M13 EWG was established to work on the development of the M13 Guideline to
harmonise bioequivalence study design and standards, which is expected would benefit
both innovator and generic product developers as the same scientific approach would be
followed in multiple jurisdictions, potentially reducing duplicative work.
57