Sj Pharma Consulting Blog Rolling Ramifications Of 'Brexit' Vote Demonstrate Need For Pharmacovigilance Audit

Numbers tell half the story: 37 million packs of medicine enter the United Kingdom from the European Union every month while another 45 million take the opposite journey. The other half of the story remains to be seen, as one of the rolling ramifications of the June 2016 "Brexit" vote will involve continued cross-continental trade with evolving oversight regulations. This fact is of great interest to those in the pharmaceutical field and those who offer pharmacovigilance auditing as a way of keeping everyone on the same page despite geographical and regulatory differences. In a September 2018 update on the topic, drug safety and regulatory affairs author and expert Bart Cobert says that future of the field through 2020 is coming into focus, but it won't be without road bumps.In Cobert's piece, he writes that Parliament voted to keep the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) as part of the European Medicines Agency (EMA) after Brexit. While "mutual recognition" of UK life sciences and pharmaceutical firms will be adhered to in the EU, additional updates from industry news outlets note that the UK will also lose its voting rights in the EMA. Also of great interest to UK entities and providers of pharmacovigilance audits is the upcoming "Implementation Period" that runs from March 31, 2019 through to December 2020. Cobert writes that the "EU is expected to implement a new clinical trials regulation (CTR) in 2020 and this will therefore apply to the UK at least through the end of 2020." The question on the minds of those who grasp the significance of pharmacovigilance - which essentially ensures safe drugs - is what happens after 2020?An article within the Withdrawal Agreement between the UK and EU does note that the UK won't be a leading pharmaceutical examiner, but the "scope of activity" remains to be seen.If you oversee a lab or testing facility that foresees having to grasp an extra layer of bureaucracy, then a pharmacovigilance audit could be in order. These companies can ensure safety of the facility while checking for strategy, organization, risk management, standard operating procedures and more. These in-person examinations can also include staff training sessions that will bring employees up-to-speed on current protocol. Given the evolving effects of Brexit, now's the time to understand what's on the horizon as well as nail down proper adverse reaction reporting rules so that the mission at the heart of pharmacovigilance is still accomplished.