FDA quicker on approval trigger than EU: study

Share this article:

Consultancy ContextMatters, in a research blog post, took hold of a study from The New England Journal of Medicine that found that the FDA “provided more rapid reviews of applications involving novel therapeutics” than its European and Canadian counterparts.

ContextMatters researchers cited what the group perceived as a flaw in the study's methodology. NEJM assumed an FDA approval was akin to approval by the EU's CHMP (Committee for Medicinal Products for Human Use) regulatory body. CHMP's nod, however, is not the equivalent of an FDA approval—drugs must still receive final approval from the European Commission before they can be marketed throughout the EU. The implication, not surprisingly, is that the difference in approval time would be even more pronounced when comparing apples to apples.

"We found that the FDA was consistently first and faster than its European counterpart to approve the 13 new treatments, with the FDA approving 11 ahead of the EMA, and completing 9 of the 13 regulatory reviews faster than the EMA," the group wrote. "We also noted that the FDA began its regulatory review before the EMA at a median time of 103 days sooner."

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.