MIKADO

A timely NDA review depends not only on the FDA or EMEA, but also on UCB submitting complete, well-organised, and easily navigated regulatory submissions. The MIKADO programme will have a positive impact by changing the way regulatory documents are authored, managed, assembled and submitted by UCB, as well as how our submissions are reviewed by the FDA.

Key regulatory agencies, including the FDA, will soon require an electronic format for the Common Technical Document, the harmonised structure and format for major components of new product applications. The electronic Common Technical Document (eCTD) format will improve the efficiency of the regulatory review process and further standardise submission formats. The MIKADO programme will deliver a global suite of tools, standards and processes that will enable "eCTD readiness" within new UCB by the end of 2007, with best practice solutions fully deployed in all areas during 2008.

Besides enabling the eCTD format, MIKADO brings additional benefits to UCB. Implementation of the new tools and processes will also increase our internal efficiency and decrease the time it takes for UCB to prepare regulatory submissions. This will be critical to offset the significant increase in the number of major submissions resulting from our growing product portfolio, and the increase in organisational complexity.

The new suite of publishing tools and processes will be available in 2007 and will be used by Global Regulatory Operations group. The new Electronic Document Management System (EDMS) will be available in 2008 and will impact all departments involved in the authoring, review and approval of documents that are included in regulatory submissions.

The first major eCTD submission for UCB is targeted to be brivaracetam during the first half of 2008. The regulatory submission team is working closely with the MIKADO programme team to plan this submission and achieve this important milestone for UCB.

Processes to support the new systems have been developed and pilot testing of the EDMS has been conducted to ensure the system works effectively with our key processes and can deliver the UCB requirements.  Specific information about the implementation of MIKADO tools and processes will be provided within the functional groups in the coming months. Targeted training is being planned and will be required for all users. With the commitment of the project team to deliver the plan and the commitment of the functions to adopt the new tools, UCB will soon be able to apply this best practice technology to gain real benefit.