Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Politicians Advance Bill to Close Drug Pricing ‘Loophole’ Legislation intended to close a drug pricing loophole in the United Kingdom has taken another step forward. The bill is designed to align two medicine price regulation schemes and, in doing so, give the government the power to stop companies from exploiting monopolies on generic drugs.   The UK runs paralle...

The European Commission on Friday proposed to review the concept of “similar medicinal products” in the context of its orphan legislation as part of a wider effort to adapt the text to technical progress. Fifteen years after the implementation of the orphan legislation, the commission says it is currently launching initiatives to improve the implementation of the regulatory framework with a view to ensuring timely access to medicinal products.  In this context, the Comm...

The fallout from the UK referendum is continuing to create strife among the ranks of the European Medicines Agency (EMA), though a top EMA official told the DIA annual conference on Tuesday in Philadelphia that business at the agency will carry on as usual as negotiations continue. Emer Cooke, head of international affairs at the EMA, said that the Brexit decision, which may cause the agency to leave London, “is a decision that affects a lot of the staff of the agency, p...

A new Senate bill introduced this week would, among other things, allow the US Food and Drug Administration (FDA) to no longer require premarket submissions for some low-risk Class I and II medical devices. The bill, which is sponsored by Sens. Amy Klobuchar (D-MN) and Pat Roberts (R-KS), and supported by industry group AdvaMed, would also: Require FDA to address within two months any changes proposed to an appropriate standard established by a nationally or internati...

The Senate’s response to the House-passed 21st Century Cures bill is slowly shifting into a series of bills, the latest of which would seek to help the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) attract top new employees. Chairman of the Senate HELP Committee Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) introduced the bill, known as the FDA and NIH Workforce Authorities Modernization Act , which enables FDA t...

The Senate Health, Education Labor & Pensions Committee (HELP) on Tuesday advanced seven bills that could serve as piecemeal counterparts to House-passed Cures legislation from last year. The swath of new bills would, among other things, streamline the US Food and Drug Administration’s (FDA) review process for innovative medical devices, bolster FDA's oversight of reusable devices, accelerate the approval process for some “targeted” rare disease drugs and aid the Nationa...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Government Backs Plan to Create Database of Off-Label and Experimental Treatments The United Kingdom government has thrown its weight behind legislation that would result in the creation of a database of innovative treatments being carried out by doctors in England, including both off-label uses of existing drugs and tests of unlicensed, experimental therapies. Official...

New EU regulations for medical devices and in vitro diagnostics (IVDs) could be adopted as early as next year, a European Commission representative told attendees at RAPS' Regulatory Convergence on Tuesday. The legislation would introduce stricter premarket rules for a range of medical devices, increase the powers and responsibilities of notified bodies and require new clinical evidence in some cases. On 5 October 2015, the Ministers of the EU countries agreed on a gene...

Late Monday evening, the House of Representatives cleared the final congressional hurdle for a bill that would compensate individuals who participate in clinical trials for rare diseases. If signed by President Barack Obama, the legislation -- the Ensuring Access to Clinical Trials Act of 2015, which passed the Senate in July -- would enable those with rare diseases to receive compensation of up to $2,000 for participating in clinical trials without having the compensati...

A new bipartisan bill aims to help accelerate the development of targeted drugs to treat rare diseases, including Duchenne muscular dystrophy, cystic fibrosis, some cancers and other genetic diseases. Although it's unclear how exactly the bill will aid in the development of targeted rare disease treatments, one of the cosponsors, Sen. Elizabeth Warren (D-MA), said the bill would clarify the US Food and Drug Administration's (FDA) current authority to consider resear...

Each year, legislators introduce dozens of pieces of legislation hoping to change how the US Food and Drug Administration (FDA) regulates pharmaceuticals, medical devices, biologics and dietary supplements. Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often. Can't find legislation you know exists...

A revised version of the 21st Century Cures Act , a bill being considered by the House Energy and Commerce (E&C) Committee, would allow medical device manufacturers to leverage third-party auditors to assess the state of their quality manufacturing systems. The measure, contained within the "Medical Device Regulatory Process Improvements" section of the bill, was first introduced in the original draft of the 21st Century Cures Act , but was removed without expla...