The impact on current mutual commerce and regulatory recognition between the UK and other EU countries was and is still unclear. Pharma cannot afford to wait and see what the impact is on the release and distribution of Clinical Trial Material from the UK into the EU. Some of the major factors to take into consideration are:
Existing inventory to be looked at includes locations of packaging and distribution within the UK and what to do with it, as well as comparator sourcing within the UK market. New locations, partners, and sourcing options need to be examined and implemented for risk mitigation purposes.
Tax laws vary country by country and changing the supply chain and import channels may have serious tax impact and appropriate compliant tax procedures need to be developed and implemented. It is also possible to establish customs license and other governmental agreements to put a sponsor in a favorable tax position.
The regulatory concerns include license changes, qualified person (QP) release recognition, and filing amendments. If a sponsor used a QP in the UK, there is risk of recognition in the EU, and vice versa. Sponsors should be prepared to have QP options in both the UK and EU post-Brexit for release.
Post hard-Brexit, after 29-Mar, it is still up in the air on how the dust will settle and sponsors should mitigate risk by limiting material movements in and out of the UK in the first several weeks after as timing and processes are too unknown to rely on.
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...
Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...