Advancing CMC Workshop

The acceleration of clinical programmes for products addressing unmet medical need requires faster CMC development efforts to deliver the physical product both to clinical development and to support commercial launches. Multiple agency expedited pathways are in place across the world to support the accelerated access of new medicines to patients. These pathways allow the use of prior CMC knowledge from related products or manufacturing platforms, alternative scientific approaches to generating data or assurance of product control, implementation of post approval change management plans or commitments to provide data during or post file. In parallel with these programs, regulatory pathways using the concepts of reliance on approval by reference countries have been implemented by many countries enabling faster access of innovative new drugs. This session will provide a regulator perspective of acceptable accelerated development approaches from key agencies. Discussions will focus on the level of harmonisation of data requirements and acceptance of scientifically driven approaches needed for more efficient accelerated development programs to be conducted.