Pharmacy, Quality Assurance, Sem- VI, B pharm

1. ICH
-PRATIK TERSE
1

2. ICH Organization
Participants of ICH:
 The ICH Steering Committee and its sub-groups are constituted of
representatives from 6 parties that represent the regulatory bodies and research
based industry in the USA, Japan and the European Union.
-Pratik Terse
2

3. ICH Organization
 Organization:
-Pratik Terse
3

4. ICH Organization
Steering Committee/ Assembly: It is a governing body of ICH that brings
together all members and observers of ICH associations.
Global Cooperation group: This group deals with operational aspects of
ICH on behalf of all members including administrative and financial matters.
It submits its recommendations and proposals to assembly.
MedDRA Management: MedDRA is a medical terminology dictionary for
regulatory activities endorsed by ICH. This clinically validated dictionary is
used by regulatory authorities.
-Pratik Terse
4

5. ICH Organization
ICH secretariat and Coordinators: ICH secretariat is located in Geneva,
Switzerland. It has responsibilities including Coordination and management
of daily ICH activities and providing support to the assembly, GCG,
MedDRA management.
ICH Working Groups: ICH working group is established for each topic
selected for harmonization. The functions of working group are in
developing harmonized guidelines, implementation of existing guidelines &
to discuss specific scientific considerations and view.
-Pratik Terse
5

6. ICH WORK PRODUCTS
WORK PRODUCTS:
Guidelines: ICH has originated over 50 harmonized Guidelines aiming at eliminating
confusions in the development and registration process
CTD: The Common Technical Document (CTD) describes the common format for the
formulation
eCTD: The Electronic Common Technical Document (eCTD) has been prepared for the
electronic submission of the Common Technical Document
MedDRA: The Medical Dictionary for Regulatory Activities (MedDRA) Terminology
has also been developed
-Pratik Terse
6

7. ICH PROCESS OF HARMONISATION
PROCESS OF HARMONISATION
The ICH Steering Committee is responsible for the administration of ICH. This includes
determining on the adoption of every ICH project, whether a new issue, maintenance of
an existing Guideline, or a specific implementation works.
ICH harmonization activities categorized into four types:
1. Formal ICH Procedure
2. Questions & Answers Procedure
3. Revision Procedure
4. Maintenance Procedure.
-Pratik Terse
7

8. ICH PROCESS OF HARMONISATION
Formal ICH Procedure
A formal ICH procedure is started with the approval by the SC of a Concept Paper and Business
Plan.
Step 1: Consensus building
 The process of unanimity starts when the Steering Committee acquires a Concept Paper as a new
topic.
 Step 1 is started when the EWG begin the preparation of a unanimity draft of the technical
document, depending on the objectives set out in the Concept Paper.
 Work is conducted via e-mail, telephonic conferences and web conferences.
 The Step 1 Technical Document with EWG signatures is then presented to the Steering
Committee to request acceptance under Step 2a of the ICH process.
Expert working group
-Pratik Terse
8

9. ICH PROCESS OF HARMONISATION
Step 2a: Confirmation of six-party unanimity on the technical document:
 Step 2a is reached when the Steering Committee accepts based on the report of the
EWG, that there is enough scientific consensus on the technical issues for the
Technical Document to proceed to the next stage of regulatory consultation.
 The unanimity text approved by the Steering Committee is signed-off by the
Steering Committee as the Step 2a Final Technical Document.
Step 2b: Espousal (Adopt) of the draft Guideline:
 Based on the technical document, the three ICH regulatory members will take the
actions they consider essential to develop the “draft Guideline”.
-Pratik Terse
9

10. ICH PROCESS OF HARMONISATION
Step 3: Regulatory consultation and Discussion
Step 3 occurs in three separate stages:
Stage I: Regional regulatory consultation
The Guideline being the scientific unanimity leaves the ICH process and becomes the subject of normal
varied regulatory consultation in the three regions.
Stage II: Discussion of regional consultation comments:
After receiving all comments from the consultation process, the EWG works to handle the comments
received and reach unanimity on what is called the Step 3 Experts Draft Guideline.
Stage III: Finalization of Step 3 Experts Draft Guideline
After due consideration of the consultation results by the EWG, unanimity is reached amongst the experts
from the three regulatory ICH members on a revised version of the Step 2b Final Draft Guideline
-Pratik Terse
10

11. ICH PROCESS OF HARMONISATION
Step 4: Acceptance of an ICH Harmonised Tripartite Guideline:
Step 4 is completed when the Steering Committee accepts, on the basis of the report
from the Regulatory Chair and the regulatory Rapporteur of the EWG, that there is
sufficient unanimity on the draft guideline.
Step 5: Implementation:
After completing Step 4, the harmonized tripartite Guideline moves immediately to the
final step of the process that is the regulatory execution
-Pratik Terse
11

12. ICH GUIDELINES
ICH guidelines are covered under four headings:
• Quality guidelines: These guidelines cover the areas of quality of drug products
such as impurity testing and stability studies and a flexible approach to quality on
the basis of GMP risk management.
• Safety guidelines: They help to detect potential risks such as genotoxicity,
carcinogenicity and reprotoxicity.
• Efficacy guidelines: These guidelines provide guidance about designing,
conducting, safety aspects and reporting of clinical trials for pharmaceutical
products.
• Multidisciplinary guidelines: Topics in pharmaceutical field that do not fit into
any of the above categories are covered under this area. This also includes details
of MedDRA, CTD.
-Pratik Terse
12

13. Quality Guidelines:
Q1A-Q1F Stability:
 Q1A: Stability testing of new drug substances and products
 Q1B: Stability testing: photostability testing of new drug substances and products
 Q1C Stability testing for new dosage forms
 Q1D Bracketing and matrixing designs for stability testing of new drug substances and
products
 Q1E Evaluation of stability data
 Q1F Stability data package for registration applications in climatic zones III and IV
-Pratik Terse
13

14.  Q2 Analytical validation:
 Q3A-Q3D Impurities:
 Q4A-Q4B Pharmacopeias:
 Q5A-Q5E Quality of biotechnological products:
 Q6A-Q6B Specifications:
-Pratik Terse
14

15.  Q7 Good manufacturing practices for Active pharmaceutical ingredients
 Q8 Pharmaceutical development
 Q9 Quality risk management
 Q10 Pharmaceutical quality system
 Q11 Development and manufacture of drug substances (Chemical entities and biological
entities)
-Pratik Terse
15

16. Safety Guidelines:
 S1A-S1C Carcinogenicity studies:
 S2 Genotoxicity studies
 S3A-S3B Toxicokinetics and pharmacokinetics:
 S4 Toxicity testing:
 S5 Reproductive toxicology:
-Pratik Terse
16

17.  S6 Biotechnological products:
 S7-S7B Pharmacology studies:
 S8 Immunological Studies:
 S9 Nonclinical evaluation for anti cancer Pharmaceuticals
 S10 Photosafety evaluation of Pharmaceuticals
-Pratik Terse
17

18. 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
-Pratik Terse
18

19.  E8 General Consideration for clinical trials
 E9 Statistical principles for clinical trials
 E10 choice of control group in clinical trials
 E11 Clinical trials in paediatric population
 E12 Clinical evaluation by therapeutic category
 E14 Clinical evaluation
 E15 Definitions in pharmacogenetics/ Pharmacogenomics
-Pratik Terse
19

20.  E16 Qualification of genomic biomarkers
 E17 Multi regional clinical trails
 E18 Genomic sampling methodologies
-Pratik Terse
20

21. Multidisciplinary Guidelines
 M1-MedDRA terminology :(Medical dictionery for regulatory activities)
 M2 Electronic standerds
 M3 Non clinical safety studies
 M4 Common technical document
 M5 Data elements and standers for drug dictionaries
 M6 Gene therapy
 M7 Genotoxic impurities
 M8 Electronic common technical document (eCTD)
-Pratik Terse
21

22. Quality Guidelines:
Q1A: Stability testing of new drug substances and products
 Stress testing.
 Selection of batches
 Container closure system
 Specification
 Testing frequency
 Storage condition
 Stability commitment
 Evaluation
 Statements / labeling
-Pratik Terse
22

23. Drug Product:
 Photo stability testing.
 Selection of batches.
 Container closure system.
 Specification.
 Testing frequency.
 Storage conditions.
 Stability commitment.
 Evaluation.
 Statements/ labeling.
-Pratik Terse
23

24. -Pratik Terse
24