22 November 2012

“ICH makes progress on ongoing reform and adopts Guidelines for safety reporting”

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in San Diego, California, USA on November 10-15, 2012. Building on the new principles of governance defined in Fukuoka, Japan in June 2012, the ICH SC approved procedural changes that reflect these principles. The ICH SC discussed further reform aimed at increasing the engagement of regulators globally and reiterated its commitment to the importance of harmonisation. Further progress was made on the individual topics, notably the safety reporting Guidelines E2B(R3) and E2C(R2) reached Step 4.

Ongoing ICH Reform: Procedural Changes and Increased Engagement

The ICH SC has finalised procedural changes implementing the agreed new principles of governance which better define the roles of regulator and industry parties within ICH that were established in Fukuoka. In addition, the ICH SC is looking into further reforms of ICH that will increase efficiency of the process and solicit greater engagement of global regulators. For this purpose, all partners are identifying structural changes to the GCG to serve as a better platform for dialogue. The ICH SC also seeks to implement a training strategy building on innovative ways to deliver training materials on core ICH topics.

In addition, the ICH SC is defining a new proactive approach to identify and creatively pursue advancements in science which can be utilised to take up potential new topics for harmonisation and/or revise existing Guidelines to reflect the current state of the art. In this context, two new groups have been established to address evolving science in the areas of quality and non-clinical drug development.

Electronic Standards

The E2B(R3) Expert Working Group (EWG) on revision of the “Electronic Transmission of Individual Case Safety Reports (ICSR)” progressed its Implementation Guide (IG) to Step 4. It is the first ICH work item to be completed under a pilot process that involved work in parallel with standards development organisations. The ICH SC endorsed the establishment of an E2B(R3) Implementation Working Group (IWG) to facilitate implementation and technical maintenance. Reflecting its joint work activities with international standards data organisations, the M5 “Data Elements and Standards for Drug Dictionaries” EWG reported on the progression towards Step 2 of the related ICH Implementation Guide. The M8 “Electronic Common Technical Document (eCTD)” EWG progressed its testing on the next major version of the eCTD (v.4.0).

Safety Update

The S10 EWG on “Photosafety Evaluation” reached Step 2 and a draft Guideline will be soon released in each region for public consultation. S1 EWG on “Rodent Carcinogenicity Studies for Human Pharmaceuticals” drafted a consensus Regulatory Notice Document (RND) and Draft Appendix of Weight-of-Evidence (WoE) approach to be published by the regulatory authority in each ICH region. The notice will request public input to a proposed change in the approach to carcinogenicity assessment, on the prospective evaluation period intended to test a new approach, and on the WoE elements proposed for inclusion in carcinogenicity assessment documents. M7 EWG on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” met in San Diego and will reach Step 2 in the coming month via postal sign-off.

Efficacy Update

The E2C(R2), Periodic Benefit-Risk Evaluation Report (PBRER) EWG reached Step 4. This revision of E2C will introduce a new periodic benefit-risk evaluation report, which represents a change in focus from individual case reports to more aggregate data evaluation. Thanks to the commitment of all ICH parties, this major revision was accomplished in less than 2 years. The ICH SC endorsed the establishment of an E2C(R2) IWG to facilitate implementation.

Quality Update

The Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” IWG met for the first time in San Diego to start the process of drafting a Q&A document to address current issues raised by the use of the Q7 Guideline, and the Q3D “Metal Impurities” EWG made good progress in defining safety assessments, risk assessments and control strategies for addressing potential metal impurities.

The next ICH Steering Committee and its Expert Working Groups meetings will be held in Brussels, Belgium on June 1-6, 2013.

For further information, please contact the ICH Secretariat at admin@ich.org.

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