Swissmedic Touts 2016 Performance: 42 New Approvals

Posted 30 May 2017 By Michael Mezher

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In its annual report released Tuesday, Swiss drug regulator Swissmedic says it outpaced the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in approving new drugs in 2016, in part due to the agency's new fast-track procedure.

In 2016, Swissmedic approved 42 new active substances (NASs), a 50% increase over the previous year and just over 50% more than EMA recommended.

"This increase shows that the pharmaceutical industry in Switzerland is continuing to invest heavily in research into and the development of medicines and is making a substantial contribution to maintaining the attractiveness of Switzerland as a base for innovation," Swissmedic said in a press release.

Thirteen of the 42 applications were also given a 140-day review under Swissmedic's fast-track procedure and another seven products were reviewed under the agency's procedure with prior notification (PPN) scheme, which allows for a 20% reduction in assessment time.

FDA’s Center for Drug Evaluation and Research (CDER) on the other hand approved only 22 new chemical entities (NCEs) in 2016, though some biological products approved by the Center for Biologics Evaluation and Research (CBER) not included in that count would be considered NASs by European agencies.

However, it's important to note that nearly all of the drugs approved by Swissmedic in 2016 had been approved previously by FDA, in some cases several years earlier.

Swissmedic also touted its review performance, noting that it completed 99% of the 12,933 regulatory applications it received during the year on schedule. For NASs and fast-track authorizations, Swissmedic says it completed all reviews on time.

Additionally, the agency said it and the country's four regional inspectorates carried out 619 good manufacturing practice (GMP) and good distribution practice (GDP) inspections, 54 more than in the previous year but only two more than in 2014.

And, for the fourth year in a row, Swissmedic reported an increase in adverse event reporting, driven by more reports from pharmaceutical companies.

Swissmedic figure 1

The agency also noted that it saw an increase in electronic adverse event reports, driven by the launch of a new online reporting portal ElViS (electronic vigilance system) in 2014 and the addition of six new companies to the agency's pharmacovigilance gateway.

Swissmedic

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Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, Submission and registration, News, Europe

Tags: Swissmedic, new active substance, New chemical entity, fast track

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