Q1/2017 At last: the EU – FDA MRA

By far the most exciting news of this quarter has been about the EU and the USA regarding their mutual recognition agreement (MRA). This MRA concerns the mutual acceptation of health care inspectorate certification of pharmaceutical manufacturing companies. As of November 2017 this brings to an end the time consuming and, for the greater part, meaningless overseas travelling of USA and EU inspectors. We expect to benefit immediately from this MRA as one of our USA clients is planned to have its facility audited by the end of 2017 and hopefully we will be able to skip this audit by providing the EU – Inspectorate with a recent FDA audit report.

Pharmacovigilance audits, however, cannot be skipped that easily and so we had another audit done this quarter on behalf of one of our clients for which we act as Qualified Person for Pharmacovigilance (QPPV). As this was a repeat surveillance audit not much surprises came on the table during this audit. Still, the EU requirements for pharmacovigilance are still not quite matured and therefore your vigilance system likewise needs continuing upgrading as did ours.

Fortunately, European regulatory affairs procedures for medicinal products are way beyond their “maturation”, ever since the start of the initial multi-state procedure back in 1992. And therefore we expect less surprises during our new DCP which has been prepared during this quarter and which will be formally submitted this month. It will be of no surprise to the regular reader of this quarterly column that this DCP concerns a radiopharmaceutical as this group of products represents one of the very core businesses of our company.