ICH reveals progress on aspects of work

At their recent meeting in Yokohama, Japan, the International Conference on Harmonization Steering Committee and its expert working groups announced progress on their work, including on safety reporting in clinical trials, electronic exchange of information (to support the work with standards development groups, such as the International Organization for Standardization, the quality of medicines and non-clinical safety. With regard to the latter, three ICH expert working groups met to further progress their efforts, taking account of ICH's ongoing commitment to promote the 3Rs animal testing agenda to "reduce, refine and replace" animal trials (Marketletter May 21).

Quality of pharmaceuticals

With respect to modernization of technical requirements for the manufacturing of high quality pharmaceuticals, an important milestone was reached with the adoption for public consultation of a new annex on Pharmaceutical Development (Q8). The annex focuses on quality by design and design space throughout the life-cycle of a drug product. To facilitate harmonized implementation of ICH guidelines, the Steering Committee agreed to establish an Implementation Working Group on the new ICH quality and manufacturing guidelines Q8, Q9 and Q10. This will concentrate on responding to questions from stakeholders and developing training materials to enhance implementation. The Steering Committee is considering the development of an ICH guideline on Development and Manufacture of Drug Substances. The decision is expected in the coming months.