The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is still considering a drastic overhaul of the 2002 medical device regulatory framework, but may have sent a signal that its new framework won’t deviate too far from established regulatory approaches.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is still considering a drastic overhaul of the 2002 medical device regulatory framework, but may have sent a signal that its new framework won’t deviate too far from established regulatory approaches. The agency reported June 16 that it has signed on with both the International Council for Harmonization (ICH) for drugs and the International Medical Device Regulators Forum (IMDRF) for devices, providing members of both industries with at least some modest confidence that access to the 67 million strong U.K. market won’t suffer from a new set of unique regulatory hurdles.
Regulatory harmonization for medical technology often seems more the stuff of gauzy dreams than bare-knuckle reality, but the Medical Device Single Review Program (MDSRP) is at the top of the list for a lot of device makers. Jeff Shuren, director of the U.S. FDA’s Center for Devices and Radiological Health (CDRH) device center, told an audience at this year’s annual meeting of the Food and Drug Law Institute (FDLI) that while the agency is very keen on the MDSRP concept, the agency would need help from Congress with the statute in order to take part, and thus the FDA will not be taking part in the MDSRP effort for now.
Citing the flexibilities implemented during the COVID-19 pandemic, the Bloomberg New Economy International Cancer Coalition is pushing to convert those improvements to a permanent paradigm shift in the way cancer patients are diagnosed, treated and cared for across the globe.
With renewed focus on the U.S. Cancer Moonshot, the price of oncology drugs is more than a satellite issue, especially as new drugs launch with ever-increasing prices and other cancer drugs continue to see price hikes.
The FDA’s proposal to harmonize the Quality System Regulation (QSR) with ISO 13485 has finally become more than just a hot topic among device makers, and the agency held a March 2 advisory hearing on the matter. One of the critical concerns for industry is the proposal of a one-year term of implementation upon publication of a final harmonization rule, a timeline that some argue should be doubled or tripled in order to serve as a practicable implementation timeline.
Small American device manufacturers are more likely to sell their products only in the U.S., and thus the FDA proposal to more closely align the Quality System Regulation (QSR) with ISO 13485 would seem to place unwarranted demands on these companies.
The U.S. FDA has at last published what is nominally a draft rule for harmonization of the Quality System Regulation (QSR) with an international standard, ISO 13485, but the draft rule is conspicuous for the absence of specifics.
Paving the way for wider dissemination of up-to-date information on drugs approved in the EU, the European Medicines Regulatory Network adopted a common standard for the electronic product information (EPI), which includes the package leaflet for patients and the summary of product characteristics for health care professionals.
We’ve been hearing for several years about an FDA proposal to overhaul its device regulatory framework with ISO 13485, potentially the most ambitious FDA undertaking in a quarter century. Those who don’t follow these things might find the subject terminally boring, but such a change could be a massive headache for industry, although it doesn’t have to be if the FDA can get the temperature of this regulatory porridge just right.
