Legal framework governing medicinal products for human use in the EU—why is it being ignored by EMA?
A certain irony…
In the Legal framework governing medicinal products for human use in the EU, the section titled 50 years of pharmaceutical legislation states:
“Much of the impetus behind the adoption of the legal framework stemmed from the determination to prevent a recurrence of the thalidomide disaster of the late 1950s, when thousands of babies were born with limb deformities as a result of their mothers taking a medicinal product during pregnancy.
This experience, which shook public health authorities and the general public, made it clear that to safeguard public health, no medicinal product must ever again be marketed without prior authorisation.
Since then, a large body of legislation has been developed around this principle, with the progressive harmonisation of requirements for the granting of marketing authorisation, and post-marketing monitoring, implemented across the entire European Economic Area (EEA).”
What irony, given that EMA has waved through dangerous gene therapy inje…