German medical device companies are growing concerned that the approval process in Europe for bringing innovative products to market is taking too long, especially when compared with the U.S., according to a survey conducted by the German medical technology association. In Australia, meanwhile, the Therapeutic Goods Administration (TGA) reported shorter approval timelines for new devices and drugs in its annual performance report. The improvements were attributed to reforms following an intense government review of regulations.
This article features excerpts from a set of recent regulatory updates focusing on time-to-market issues from BioWorld MedTech, the daily medical device and diagnostics news service from Clarivate Analytics. Click here to see the full report.
Germany’s BVMed sees device approval too slow
The annual “Autumn 2018 Survey,” conducted by the German medical technology association known as the Bundesverband Verbandmittel und Medicalprodukte (BVMed) and released Oct. 10, covered all aspects of med-tech business and regulations.
It showed, on the positive side, that the “innovation climate,” or business confidence, of the German med-tech industry had rebounded in 2018 for the first time since a sharp drop in 2014. On average, Germany’s med-tech companies expect revenue growth in 2018 of 4.2 percent on the year, up from a mild gain of 2.8 percent in 2017. Despite the solid growth rate, BVMed noted that Germany still lags behind the global med-tech revenue growth rate of 5.9 percent.
‘We must become active’
The survey found that a positive – and quick – decision from the powerful Federal Joint Committee, known in Germany as the G-BA, which chooses the medicines and devices that will be paid for by the public health insurance system, can translate into a huge boost in revenue for med-tech companies. Germany’s massive public system covers more than 90 percent of the population.
“We must become active,” said BVMed CEO Joachim Schmitt, adding that med-tech companies need to lobby for “faster benefit assessment” decisions from the G-BA and for “pragmatic solutions” to the current ongoing implementation of MDR regulations in Europe.
Reforms lead to shorter approval timelines
In Australia, the TGA’s annual performance report covered the period from July 2017 to June 2018.
The shortened timelines highlighted in the findings were attributed to reforms that went into effect in July 2017 that created new pathways to speed access to drugs and devices. New regulations were implemented in relation to orphan drugs, special access schemes, authorized prescriber schemes, priority pathways for drugs and devices, inspection programs, a provisional approval pathway for drugs, an automated notification process for low-risk changes to biologics and a pathway for using assessment reports from comparable overseas regulators for devices.
Read the December MedTech update here.
This article was excerpted from a new compilation of regulatory updates written by BioWorld MedTech Staff Writers Ned Stafford, based in Germany, and Tamra Sami, based in Australia. BioWorld MedTech is the global news service providing med-tech updates and analysis from Clarivate Analytics. To access the full report, please click here.
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