Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting. Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients.
The European Medicines Agency, (EMA), oversees medicine regulation within the EU and evaluates applications for medicines to receive marketing authorization across the bloc. It has been based in London since it was founded in 1995.
However, as Brexit is completed the regulatory body will move from its current headquarters in London and as many as 20 EU countries may bid to host the headquarters of the EMA and its staff of almost 1000.
Portugal is the latest to join the competition and other contenders include the Netherlands, Ireland, Sweden, Austria, Denmark and Spain. Potential interest has also been expressed by Belgium, France, Germany, Luxembourg, Finland, Cyprus, Malta, Greece, Portugal, Slovenia, Slovakia, Poland and Hungary. Only the Czech Republic and Estonia have said they would not be vying for the EMA headquarters.
No precise timetable for the transfer has been set, and the EMA itself will have no direct say in the decision. Rather, representatives of the EU Member States will vote to determine the outcome.
Hosting the headquarters should be financially attractive. In addition to the large permanent staff, regulators from member countries are constantly in attendance at the headquarters for meetings and work. It could also be expected that established international big pharma companies as well as emerging European pharmaceutical businesses might locate offices or headquarters in the EMA host city.
However, a number of potential problems loom as the relocation is considered. Pharmaceutical companies fear there could be drug approval delays when the headquarters makes its move. Reportedly a large number of senior staff have left EMA since the Brexit vote and EMA is also likely to suffer a further loss because of the significant amount of review and approval work done by the UK Medicines & Healthcare Products Regulatory Agency (MHRA). And, the MHRA will face a challenge of how closely to continue to harmonize its regulations with those of the EMA which some UK critics say would allow EMA to continue to dictate the content of the regulations.
As with much of the economic and political adjustments being made during the transition period after Brexit, the one constant at this time seems to be uncertainty.
Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated GMP storage, labeling, kitting and temperature-sensitive drug distribution services. For more information about how Sentry’s GMP services can help protect the integrity and delivery of your biological products to patients, contact Sentry via email or by phone at 1-866-757-7400.