The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Osaka, Japan on 9 – 14 November 2013. The ICH SC furthered discussions on governance and increased engagement of regulators globally that had taken place in La Hulpe (Brussels) in June 2013. The SC agreed on organisational reform measures to foster international cooperation. In addition, the SC agreed to develop a 5-year plan for future ICH work and discussed potential new ICH topics to be further explored before the next meeting. With regard to ICH documents under development, further progress was made on the S10 Guideline on \u201cPhotosafety Evaluation\u201d which reached Step 4 in Osaka.<\/p>\n
The ICH SC reviewed proposals for new topics provided by all parties and agreed on the development of concept papers for potential items such as providing further harmonisation on requirements for clinical trials. The SC will further discuss and prioritise potential new quality topics before the next face-to-face meeting. In order to improve the strategic oversight on ICH work, future topics will be integrated in a 5-year plan.<\/p>\n
The ICH SC continued its discussions on the reform of ICH. Principles for new rules of governance and membership were adopted that will allow regulatory authorities and industry global associations which apply ICH Guidelines, to be more involved in ICH activities. The ICH SC also exchanged views on new approaches for ensuring the resources to support ICH activities.<\/p>\n
The M8 Implementation Working Group (IWG) \u201cElectronic Common Technical Document (eCTD)\u201d has updated the current specification with progression to Step 4 of the V1.25 Question and Answer and Change Request document.<\/p>\n
The ICH SC noted the work of E2C(R2) IWG that is working on a Q&A regarding the implementation and technical maintenance of the \u201cPeriodic Benefit-Risk Evaluation Report\u201d, which reached Step 4 in May 2013. The E2C(R2) IWG aims to reach Step 4 of the Questions and Answers (Q&As) by the end of 2013.<\/p>\n
The S10 EWG on \u201cPhotosafety Evaluation\u201d reached Step 4 in Osaka. The Safety Brainstorming Session reviewed sixteen potential future topics and provided its recommendations to the ICH SC on priority topics. ICH agreed on the development of concept papers for priority topics.<\/p>\n
The Annex 6 \u201cEvaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions\u201d to the Q4B Guideline reached Step 4. This harmonisation of pharmacopoeial texts in the three regions will reduce testing requirements for the industry.<\/p>\n
The Q7 IWG on \u201cGood Manufacturing Practice Guide for Active Pharmaceutical Ingredients\u201d met for the third time to develop a Q&A document to address current issues raised by the use of the Q7 Guideline. Its work focused on the development of Q&As based on the survey conducted in late 2012.<\/p>\n
In 1999, ICH released MedDRA as its standardised medical terminology. The maintenance and support of MedDRA is contracted to a Maintenance and Support Services Organisation (MSSO). ICH has decided that a new Call for Tender should be undertaken. This decision represents the interest of the ICH to conform with good business practices and does not reflect on the performance of the current contractor. ICH will publish a Request for Information\/Call for Expression of Interest in early 2014, in order to identify interest from potential service providers.<\/p>\n
The next meeting of the ICH Steering Committee, its Expert Working Groups and Implementation Working Groups, will be held in Minneapolis, MN, USA on 31 May – 5 June 2014.<\/strong><\/p>\n