Harmonisation panel makes progress on CTD
progress being made on a number of fronts, including the common
technical document.
The latest meeting of the International Conference on Harmonisation steering committee saw progress being made on a number of fronts, including the common technical document (CTD).
The CTD is intended to serve the regulatory needs of regulatory bodies in the three ICH regions (Europe, the USA and Japan) with regard to the technical requirements for registering medicinal products. The idea is that a great deal of duplicative work could be avoided, if the core of a medicine's regulatory dossier was applicable to all three regions.
A series of Question & Answer documents were reviewed and will be posted on the ISH website once endorsed. A large proportion of the content of these Q&A's relates to the proposed electronic CTD.
The steering committee meeting also heard calls for a harmonised pharmaceutical quality system applicable across the lifecycle of a product and emphasising an integrated approach to risk management.
The panel agreed that ICH will work on this issue, providing guidance on the use of risk-management in pharmaceutical development, as well a better definition of the principles by which risk management is integrated into quality decisions, including Good Manufacturing Practice (GMP) compliance both by the regulators and industry.
Industry representatives said they would examine areas of perceived differences in the three ICH regions on quality systems and report their findings to the committee.Meantime, the second announcement for the next ICH meeting, due to be held 12-15 November in Osaka, Japan, has been published on the organisation's website. Topics for discussion include the CTD, pharmacovigilance, the comparability of biological and biopharmaceutical agents subject to changes in their manufacturing processes, safety pharmacology and gene therapy.
