Ever wonder how those harmonized guidelines that address the technical and scientific aspects of drug development come about? The International Council for Harmonization (ICH) plays an important role and has a specific process for creating and maintaining these documents. This blog will describe the steps involved in crafting an ICH guideline, ensuring the path from concept to finalized guidance is thorough and efficient.
Planting the Seed - The Concept Paper
The journey begins with a well-defined idea. The ICH Assembly considers a "Concept Paper" outlining the need for a new guideline and a Business Plan or roadmap for its development. The paper ensures everyone is on the same page about the goal and the path to get there. An expert working group (EWG) is formed to draft the guideline and shepherd it through the formal ICH process.
Step 1: Consensus Building – Technical Document
The Expert Working Group (EWG) develops a consensus draft of the Technical Document in line with the objectives of the Concept Paper, using e-mail, teleconferences, and web conferences for coordination. If the ICH Management Committee approves it, the EWG convenes in person during the biannual Assembly meetings. Progress updates on the draft are regularly presented to the Assembly. Once the EWG reaches a consensus, the technical experts sign the Step 1 Experts sign-off sheet. This signed document is then submitted to the Assembly, requesting adoption under Step 2 of the ICH process.
Step 2a: ICH Parties Consensus on Technical Document
Step 2a is achieved when the Assembly, upon reviewing the Expert Working Group's (EWG) report, agrees that there is enough scientific consensus on the technical aspects of the Technical Document for it to advance to the next phase of regulatory consultation.
Step 2b: Draft Guideline Adoption by Regulators
Based on the Technical Document, the ICH Regulatory Members will take necessary actions to develop the draft Guideline. Step 2b is reached when this draft Guideline is endorsed by the Regulatory Members.
Step 3: Regulatory Consultation and Discussion
Step 3 of the process unfolds through three stages involving regulatory consultation, discussion, and the finalization of the Step 3 Expert Draft Guideline:
Stage I - Regional regulatory consultation: The scientific consensus embodied in the Guideline exits the ICH framework and enters a broad regulatory consultation phase across the ICH regions. Regulatory bodies and industry groups from other regions can also provide feedback by submitting comments to the ICH Secretariat.
Stage II - Discussion of regional consultation comments: The Expert Working Group (EWG) reviews all feedback received during the consultation period, working to address these comments and achieve consensus on what is known as the Step 3 Experts Draft Guideline.
Stage III - Finalization of Step 3 Experts Draft Guideline: Following the EWG’s thorough review of the consultation feedback, if consensus is reached among the experts on a revised version of the Step 2b draft Guideline, this Step 3 Expert Draft Guideline is signed by the experts from the ICH Regulatory Members. This signed document is then submitted to the Regulatory Members of the Assembly to seek adoption as Step 4 of the ICH process.
Step 4: Adoption of an ICH Harmonized Guideline
Step 4 is achieved when the Assembly confirms that there is sufficient consensus on the draft Guideline. Following this agreement, the Step 4 Final Document is officially adopted by the ICH Regulatory Members of the ICH Assembly as an ICH Harmonized Guideline, marking the completion of Step 4 in the ICH process.
Step 5: Implementation
Upon reaching Step 4, the harmonized Guideline advances directly to the final step, which is regulatory implementation. This step is conducted in accordance with the standard national or regional procedures that govern other regulatory guidelines and requirements within the ICH regions.
Revisions
The revision procedure for ICH Guidelines is activated when an adopted Guideline's scientific or technical content becomes outdated or incorrect or new information must be included. Two types of revisions can occur. Revisions may involve direct amendments to the existing Guideline's content if it is outdated or incorrect. Alternatively, the creation of an Addendum or Annex to provide additional guidance without altering the original text may be necessary.
Substantial revisions are handled using the formal ICH Step process, while minor errors or terminology issues may be addressed by reconvening the original EWG to discuss necessary changes without initiating the full Step process.
The Importance of the ICH Process
This broad development process highlights how regulatory collaboration can enhance efficiency and foster innovation across borders. It ensures that any guidance developed is robust, comprehensive, and harmonized across different regulatory jurisdictions.
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