Blog - MHRA Inspectorate
The pharmacovigilance systems of marketing authorisation holders are often dependent on multiple third parties; extensive outsourcing and partnering is a feature of the pharmaceutical industry as much as any other. This blog expands upon the areas identified as problematic for MAHs and service providers and provides points to consider when producing contracts and agreements text.
EMA Patient Registry Initiative
A new discussion paper has been published for comments, which covers methodological and operational considerations in the use of patient disease registries for regulatory purposes. In addition, the EMA has announced that Registries should be preferred to Clinical Trials for the investigation of factor VIII and factor IX haemophilia medicines in previously untreated patients and corresponding guidelines have been published.
FDA RWE Program
The FDA is calling for comments on a framework created to evaluate the potential use of real-world evidence (RWE) in regulatory decision making.
Product Safety news
Further to a Public Hearing held in June 2018, the EMA has now confirmed restrictions on fluoroquinolone and quinolone antibiotics to reduce the risk of disabling and potentially long-lasting side effects. Medicines containing a quinolone antibiotic are now suspended in the EU and restrictions apply to remaining fluoroquinolone antibiotics.
MHRA PV Inspection metrics
The MHRA has published a new set of Pharmacovigilance Inspection metrics, which provides trends and details regarding Inspection Findings. The report also shows that whilst the number of inspections is decreasing, their duration is increasing significantly.
Hot topics are taken from Safety Observer Lite 151, Dec 2018