The Ongoing Journey of the One Voice of Quality for Post-Approval Changes (1VQ for PAC) Initiative

Since 2018, the Chief Quality Officers (CQOs) of the top 25 pharma companies have spoken with one voice of quality on the topic of post-approval changes (1VQ for PAC Initiative). The 1VQ for PAC Initiative has developed practical approaches to significantly reduce the complexity of the global PAC regulatory framework. This current framework poses a risk to the supply of products to patients, as it drastically slows innovation and continual improvement. The CQOs built on an opportunity from the ICH Q10 Guideline to earn regulatory flexibility, allowing management of more PACs in the Pharmaceutical Quality System (PQS) only and have published a definition of an effective PQS. The 1VQ for PAC Initiative has also published data for more than 145,000 PACs covering 156 countries, illustrating the size of the PAC management problem. The CQOs continue to advocate eight practical solutions, including managing more PACs in the PQS only and implementing agile regulatory reliance practices amongst regulatory agencies.