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Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceuticalproducts is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment.
In recent times, suppliers have also chosen other systems that rely on blockchain and sensors to track drug supply and reduce the influx of counterfeit drugs. In recent times, various global administrators have issued regulatory standards. In 2020, Fresenius Kabi introduced their first RFID-enabled medication, Diprivan +RFID.
Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. How can these issues be addressed?
Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and DrugAdministration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.
This also occupies a large resource, given the US Food and DrugAdministration (FDA) requirement for double plate checking using a second ‘independent’ person. Tony Cundell: Perhaps the second greatest challenge is the ongoing transition from products based on small molecules to large molecules to cellular therapies.
They must be familiar with the different national authorities; the Food and DrugAdministration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. Department of Justice, 2020). Department of Justice, 2020).
The US Food and DrugAdministration (FDA) has sent a warning letter to KVK-Techs drug manufacturing facility following an inspection in April 2019. The document identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.
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