2 December 2014

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Lisbon, Portugal, EU on November 8-13, 2014. The meeting was hosted by the European Commission and included over 300 participants.

The SC agreed on the key issues relating to the reform of ICH in terms of governance, new membership and funding. ICH remains committed to enhanced communication, transparency and the openness of ICH to all relevant stakeholders. The SC will now proceed with finalising the Articles of Association and funding model that will allow the ICH parties to carry out their internal consultations, which will pave the way towards establishing ICH as a legal entity as an international association under Swiss law. Membership in the Assembly, which will be the overarching body of the Association, will be established as soon as the legal entity has been set up.

The SC had also organised a special session to inform interested parties on the state-of-play of the reform and to seek their views. All participants recognised the essential role of ICH in the development of internationally harmonised technical requirements for the registration of medicinal products and welcomed the objectives of the reform. They will be kept informed of ongoing developments.

Safety Update
The SC adopted the Concept Paper on Nonclinical Safety Testing of Development of Paediatric Medicines (S11). This Guideline is needed to establish standards for the conditions under which nonclinical juvenile animal testing is considered informative and necessary to support paediatric clinical trials, and to provide guidance on the design of the studies.

Efficacy Update
The EWG created to develop an Addendum to E6, Good Clinical Practices (GCP), made good progress towards a Step 2a document (expected in June 2015) considering innovative approaches to GCP.

A new EWG on E9(R1) met to create an Addendum addressing the appropriate estimand in a clinical trial and the definition of the sensitivity analysis. The focus is to harmonise what “effect” a clinical trial should seek to estimate to avoid risk of inconsistent decision making. A newly created EWG met to address scientific and technical advances in paediatric drug development by developing an Addendum to E11. The Addendum will address methodological approaches, commonality of content in plans for pediatric drug development, ethical considerations, and age classification. It will also include high level consideration on extrapolation, modeling and simulation and paediatric formulations.

The EWG developing the Guideline on Multi-Regional Clinical Trials (MRCTs) (E17) met for the first time and made progress on developing a Guideline which will promote appropriate conduct of MRCTs, resulting in further use of data from MRCTs in multiple regions and better regulatory decisions.

The development of the E18 Guideline on Genomic Sampling Methodologies for Future Use began with the first meeting of the EWG. This Guideline will clarify points to consider in collecting Genomic samples in clinical trials.

The E2B(R3) IWG has finalised its work on a Question & Answer (Q&A) document and updated the ICSR Implementation Guide package during the Lisbon meeting. The Q&A document, which includes 27 Q&As, was signed-off by the SC at Step 4.

Work was also progressed on a revision of the CTD Efficacy Guideline by the recently established M4E(R2) EWG. The aim of the revision is to include greater specificity on the format and structure of benefit-risk information with the goal of harmonising the presentation of this information in regulatory submissions.

Quality Update
The Q7 Implementation Working Group (IWG), Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, also met to continue its work on developing Q&As to address current issues raised by the use of the Q7 Guideline. The final set of 55 Q&As was agreed upon and will be sent out to obtain agreement from the constituencies regarding the final Q&A document prior to adoption and posting on the ICH website.

A new EWG on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Q12) met for the first time. The aim of the Guideline is to facilitate post-approval changes in a more predictable and efficient manner, promote innovation, managing quality and continual improvement throughout the lifecycle.

The ICH SC approved the Concept Paper and Business Plan for the development of Q&As to Q11 for the purpose of clarifying the selection of starting materials for the manufacture of drug substances and what information should be provided in the marketing authorisation application or master files. An IWG will be formed to carry out this work.

Electronic Standards
The M2 EWG (Electronic Standards for the Transfer of Regulatory Information) and the M8 EWG (The Electronic Common Technical Document - eCTD) met in Lisbon. MedDRA The ICH M1 Points to Consider Working Group met at EMA in London on November 10 – 12, 2014 to discuss refinements to the coding of medication errors considering the EU medication error project as well as off label use and other related concepts in MedDRA.

The next ICH Steering Committee Meeting and its EWG meetings will be held in Fukuoka, Japan on June 6 – 11, 2015.

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

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