The EMA have shifted to a progressive implementation. Instead of a single milestone, as we’ve been used to for regulations, there will be a series of deadlines and MAHs will be expected to enrich data iteratively in the Product Management Service. More and more data will be required with each iteration of PMS. This is more challenging, and preparing data in advance will be essential to ensure continued compliance.
Without the right preparation, MAHs could find themselves with inefficient manual processes becoming more burdensome with every new demand for data from the EMA, leaving them at risk of falling behind and not being able to meet EMA requirements. Putting in place efficient solutions, effective processes and the right tools is vital.
MAHs need to be ready: timelines vary depending on portfolio, but all MAHs face new deadlines. Don’t delay: get your data, tools and people ready today.