ICH Harmonization Activities

Ques 1. International Council for Harmonization of __________________ for Pharmaceuticals

for Human Use.
Ans 1. Technical Requirements

Ques 2. What is the mission of ICH?

Ans 2. The mission of the ICH is to promote public health by achieving greater harmonization through
the development of technical Guidelines and requirements for pharmaceutical product registration.

Ques 3. Harmonization leads to a more rational use of human, animal and other resources,
the elimination of unnecessary delay in the global development, and availability of new
medicines while maintaining safeguards on _______, _______, _______ and regulatory
obligations to protect public health.

Ans 3. quality, safety, efficacy,

Ques 4. The structure of ICH includes __________ and __________.

Ans 4. Regulatory body and Industry.

Ques 5. Types of ICH guidelines and name them.

Ans 5. There are 4 types of ICH guidelines. They are as:
• Quality guidelines
• Safety guidelines
• Efficacy guidelines
• Multidisciplinary guidelines

Ques 6. What is the full form of:

• CTD
• ESTRI
Ans 6. A) Common Technical Document.
B) Development of Electronic Standards for the Transfer of Regulatory Information.

Ques 7. Name the categories of ICH harmonization activities.

Ans 7. ICH harmonization activities fall into 4 categories:
A) Formal ICH Procedure
B) Q&A Procedure, Revision Procedure
C) Maintenance Procedure
D) Depending on the activity to be undertaken.

Ques 8. What is a concept paper?

Ans 8. Each harmonization activity is initiated by a Concept Paper which is a short summary of the
proposal.

Ques 9. What does a business plan outline?

Ans 9. The Business Plan outlines the costs and benefits of harmonizing the topic proposed by the
Concept Paper.

Ques 10. What is the Formal ICH Procedure? What are its steps?
Ans 10. The Formal ICH Procedure is a step-wise procedure consisting of 5 steps (see below, click to
have information on a particular step). This procedure is followed for the harmonization of all new ICH
topics.
The formal ICH Procedure is of 5 steps:
1. Consensus building.
2. ICH Parties consensus on the Technical Document.
3. Regulatory consultation and Discussion.
4. Adoption of an ICH Harmonized Guideline.
5. Implementation.

Ques 11. What is EWG and what does it do?

Ans 11. An Expert Working Group (EWG) is subsequently established. It works to develop a draft
Guideline and bring it through the various steps of the procedure which culminate in Step 5 and the
implementation in the ICH regions of a Harmonized Guideline.

Ques 12. What is Consensus building?

Ans 12. The EWG works to prepare a consensus draft of the Technical Document, based on the objectives
set out in the Concept Paper. Work is conducted via e-mail, teleconferences and web conferences.
If endorsed by the ICH Management Committee, the EWG will also meet face-to-face at the time of the
biannual Assembly meetings. Interim reports on the progress of the draft are made to the Assembly on a
regular basis.
When consensus on the draft is reached within the EWG, the technical experts of the EWG will sign the
Step 1 Experts sign-off sheet. The Step 1 Experts Technical Document with EWG signatures is then
submitted to the Assembly to request adoption under Step 2 of the ICH process.

Ques 13. The revision of a Guideline is designated by the letter ______ after the usual
denomination of the Guideline. When a Guideline is revised more than once, the document
will be named _____, ______, ______etc.
Ans 13. R1............. R2, R3, R4

Ques 14. What is Question and Answer Procedure?

Ans 14. The Q&A Procedure is followed when additional guidance is considered necessary to help the
interpretation of certain ICH harmonized Guidelines and ensure a smooth and consistent implementation
in the ICH regions and beyond. Additional guidance is usually developed in the form of Questions and
Answers "Q&As".

Ques 15. What is Revision Procedure?

Ans 15. The Revision Procedure is followed either in cases where the scientific/technical content of an
existing ICH Guideline is no longer up-to-date or valid, or in cases where there is new information to be
added with no amendments to the existing ICH Guideline necessary. In the case of the latter, the new
information can be added in the form of an Addendum or an Annex to the Guideline in question.