International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

As an employee of a small pharmaceutical company headquartered in the United States that is working toward its first NDA submission, you are using the ICH Guidelines to guide you through many aspects of product development and clinical trial activity. From time to time, you would like clarification on aspects of the ICH Guidelines. What is the best source for such clarification? Who would you contact and how?

1. It seems to me the best possible place to look first would be the ICH itself. The guidelines do no provide rules or regulations and change all the time- allowing open interpretation in some cases. The ICH has a The ICH has a Q&A process where individuals can submit questions, comments and concerns. The ICH then may alter or clarify their guidelines as needed.

Questions & Answers Procedure

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

The Q&A Procedure is driven by questions/issues raised by stakeholders, which serve as the basis for the development of model questions for which standard answers are developed. To assist the process, stakeholders are often invited via the ICH website to submit their questions on a specific Guideline.

The procedure is initiated with the endorsement by the ICH Assembly of a Concept Paper. In the case of major implementation activities, the Assembly may also consider the need for Business Plan. An Implementation Working Group (IWG) is subsequently established. The IWG works to reach consensus on a draft Q&A document and makes a recommendation to the Assembly on whether the document should be a Step 2b draft Document published for consultation or a Step 4 final Document published as final without consultation. This recommendation is based on the level of information provided by the answers.

The document then follows the normal path of a Step 2/Step 4 Document as per the Formal ICH Procedure.

2. The ICH has also developed the Common Technical Document (CTD) which is in fact, included in the multidisciplinary guideline. This document outlines information regarding organization, quality, safety, and efficacy. The formats presented in the CTD is agreed upon the FDA, and could greatly aid a small business in formatting their first submissions.

3. Additionally, forming a network and reaching out to other companies may provide good resources as well. There are various working groups and industries that a small company would benefit from forming a connection or partnership with. Being part of similar fields, these individuals may be able to provide good advice based on their experiences with the ICH.

4. Finally, considering the fact that the ultimate acceptance decision is made by the FDA, it may benefit a small company to contact FDA staff responsible for implementation of such guidelines to receive clarifications and advice. A pre-NDA meeting could also be arranged, allowing both the company and the FDA to better prepare for the NDA submission.

Categories: Clinical