Octobre 2018

The ICH finally published in December 2017 the draft version of its guideline ICH Q12 « Technical and regulatory considerations for pharmaceutical product lifecycle management ». Highly discussed and awaited since the concept paper issued end 2014, this draft guideline provides a framework to facilitate the management of post-approval changes which impact the CMC part of the regulatory dossier. Its application is expected to promote innovation and continual improvement in the biopharmaceutical sector and ultimately, will benefit patients, industry, and regulatory authorities.