Will it be a sigh of relief for drug makers?
In a recent announcement pertaining to the Good Pharmacovigilance Practice (GPvP), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated that it no longer wants GPvP compliance reports to be submitted by organizations. With the update expected to drastically bring down the procedural complexities, will it be a sigh of relief for drug makers?
Perhaps no, we could say. Though the agency has dropped the requirement of GPvP compliance reports, it may anytime contact organizations for necessary information about the pharmacovigilance systems and authorized products. So, it is still an obligation to companies to maintain or follow the Good Pharmacovigilance Practices which are going to be useful, when necessary.
Why the reports were needed?
In a routine practice, as MHRA describes, the GPvP compliance reports were needed for the data to support inspection scheduling and planning activities and also to understand the PV systems in the UK for enhancing the information that they maintain on inspection universe.
What makes a ‘no’ to GPvP Compliance Reports?
The main reason the regulatory agency quoted for dropping down of GPvP compliance reports is that they now have access to various information sources which can support their activities related to scheduling and planning. The agency has also asserted that the current move to halt the compliance reporting will not affect other pharmacovigilance practices and it will continue its risk-based inspection activities, as usual.
Having said that, though it is not mandatory for drug makers to submit GPvP compliance reports, they are entitled to be inspection ready for MHRA’s need based and risk-based inspection activities. It will never be a sigh of relief for drug makers while considering Good Pharmacovigilance Practices. Be vigilant to be compliant.