Swissmedic Sees Spike in Adverse Event Reports for Third Straight Year

Posted 06 June 2016 By Zachary Brennan

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In a new report on its work in 2015, Switzerland’s drug and medical device regulator Swissmedic has seen a sharp rise in the number of suspected adverse drug reaction (ADR) reports received (7.1% increase from 2014 and a more than 30% increase from 2013), due mainly to an increased volume of reports from industry.

“The number of follow-ups to ADR reports is now also being recorded as a big increase in the number of reports was observed during the year and they are labour-intensive (2,156 follow-ups),” Swissmedic said in its annual report. “A total of 26 signals concerning 87 medicinal products were generated from the ADR reports received from Switzerland, and these were investigated in detail.”

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The rise in adverse events also coincides with a rise in health product quality defects detected by the Swiss regulator.

“Compared with 2014, there was again a 10% increase in the number of quality defects reported,” the regulator said. And of the total of 679 reports submitted, Switzerland was affected by 454 of them and officials carried out 28 batch recalls.

Inspections

In 2015, the Swissmedic inspectorate conducted 77 good manufacturing practice (GMP) and good distribution practice (GDP) inspections, while regional officials conducted 488 GMP/GDP inspections of manufacturers and wholesale companies, which was fewer inspections than years prior.

The inspections dealt with blood transfusion services (35%), pharmaceutical sector inspections (31%), “for cause” inspections (18%), transplant products (12%) and pre-approval inspections (4%).

“More intensive enforcement of company monitoring led to Swissmedic carrying out twice the number of ad hoc inspections due to complaints or suspected infringements of the law,” the report says.

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And after a brief interruption in 2014, Swissmedic was once again involved in inspection programs organized by other regulators outside Switzerland in 2015.

“In this context, four active pharmaceutical ingredient manufacturers – two in India, two in China – were inspected in collaboration with the European Directorate for the Quality of Medicines & HealthCare (EDQM) and a blood transfusion service in Indonesia was inspected with the WHO,” Swissmedic said, noting that it also took part in several assessments of partner authorities within the framework of the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

Swissmedic also saw an increasing number of foreign regulators conducting inspections inside its borders.

In 2016, foreign authorities carried out 58 GMP inspections at pharmaceutical companies in Switzerland, including 24 from the US Food and Drug Administration, eight from the Korea FDA, Turkey with five, Brazil, Kazakhstan and Kenya with three each, Iran, Mexico and Russia with two each, and Belarus, China, Taiwan, Libya, the Gulf Cooperation Council and Uganda with one each.

Swissmedic also accompanied US FDA and the European Medicines Agency on two good clinical practice inspections in Switzerland.

Devices

In addition to the increase in pharmaceutical adverse events, such reports on Class I medical devices (which includes reusable surgical instruments, adhesive plasters and rolling walkers) increased 50% to 485 in 2015. The number of reports on in vitro diagnostics (IVD) also increased slightly, Swissmedic said.

Meanwhile, the number of requests for mutual assistance for devices from European partner authorities also more than tripled to 151, the report adds. 

By the Numbers

As far as drug approvals and other fast-track designations, in 2015, Swissmedic received 295 applications for first authorizations of innovative medicinal products and major variations and 252 applications were completed.

“Of the 28 medicinal products with new active pharmaceutical ingredients that were authorized for the first time (32%), nine were completed by means of the fast-track procedure,” the report says. “Of the 277 applications for non-innovative first authorisations, 57 concerned co-marketing products. Three requests for the parallel importation of a medicinal product were submitted in 2015.”

As far as the fast-track procedure, 23 requests were submitted, 13 of which were approved.

As an agency, Swissmedic staff headcount at year end included 424 full-time positions and the average Swissmedic employee is a 47.5 year old female who speaks German.

New Swissmedic Annual Report

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Postmarket surveillance, News, Europe, EMA, EC

Tags: Swissmedic, adverse event reports, European drug regulators, Swissmedic

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