Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 21 July 2016 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Novartis has revealed the Medicines and Healthcare Products Regulatory (MHRA) has criticized its UK operation following an inspection. The criticisms center on the systems Novartis’ UK unit uses to provide health authorities with access to trial data.
Specifically, Novartis said MHRA inspectors were critical of the ease of access to its systems. Novartis has downplayed the significance of the regulatory finding, noting that an existing project is set to address the criticism. Neither Novartis nor MHRA has released specific details of the faults found by the inspectors, or what the company is doing to address the shortcomings. Novartis disclosed the outcome of the inspection in a release regarding its second quarter financial results.
In recent years, Japanese regulators have repeatedly criticized Novartis, in part over its approach to data management and reporting. The headline charge against Novartis was that it had failed to promptly report more than 3,000 adverse events relating to more than 20 drugs, an allegation that led to health officials suspending most of the company’s sales operations for 15 days. The suspension was implemented in March 2015, since when Novartis’ Japanese unit has managed to avoid scandal.
The update to disclose the MHRA inspection results adds to the impression that the UK finding is an isolated, rather than systemic, problem. Novartis went through 74 inspections by health authorities in the first half of 2016. FDA conducted 13 of the inspections. Of the 74 inspections, 73 resulted in findings deemed good or acceptable. MHRA was the only regulator to conclude the operation it inspected was unsatisfactory.
The Swiss Agency for Therapeutic Products (Swissmedic) is aiming to start its electronic application processing pilot project by the middle of October. If Swissmedic hits that deadline, it will position the agency to make the online portal available to all authorization holders by the start of April 2017.
Swissmedic sees the pilot project as the start of a process that will result in a lot of correspondence between it and the industry taking place electronically. The plan is for approval and change requests, answers to correspondence and other regulatory orders and communications to go through the portal. Swissmedic is working with the existing eGovernment portal, which is already used for a range of government services.
To ensure the portal is ready for widespread use by the biopharma industry by April, Swissmedic is granting access to it to a select group of companies later this year. Exactly when this happens will depend on how quickly Swissmedic can complete development and quality testing. The hope is that the six-month pilot project will provide Swissmedic with the feedback and time it needs to optimize the portal ahead of its full launch.
If Swissmedic meets its mid-October target, the pilot project will start almost exactly two years after the regulator introduced ElViS, its previous notable electronic portal. ElViS, an acronym of Electronic Vigilance System, went live in October 2014 following a pilot phase. Swissmedic adopted the portal to enable healthcare professionals to prepare and file adverse event reports electronically. The portal was also made available to companies that went through a half-day training course.
Swissmedic Notice (German)
The European Medicines Agency (EMA) has recommended suspending Velactis seven months after it was approved. EMA made the ruling after it received 319 reports of adverse events in dairy cows that received the drug to cut milk production.
CEVA Santé Animale, the marketing authorization holder of Velactis, has already halted sales of the drug, while some member states have independently suspended the product. EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) has now called for a European Union-wide suspension and a recall of batches already on the market. The regulator took the decision after concluding the risks of Velactis currently outweigh the benefits.
This position is underpinned by a spate of adverse event reports. EMA has received reports that 319 dairy cows have suffered adverse events after receiving Velactis. Many of the adverse events were classed as serious. More than 200 cows lay down and were unable to stand, a condition known as recumbency. Overall, 71 cows have died after receiving the drug. Most of the deaths followed a period of recumbency.
EMA is unsure how the drug is causing these adverse events, but evidence suggests it is at the root of the incidents. Work is now underway to understand what is happening and whether Velactis can be used safely. Velactis will remain suspended until CVMP sees evidence that the benefits outweigh the risks. This may only be achievable by modifying the conditions under which the drug is given, or perhaps by restricting the situations in which it is used.
CVMP has elected Helen Jukes as its vice chair. The election gives a British person a three-year term in a leadership position at CVMP at a time when the status of European officials who originate from the United Kingdom has been thrown into doubt by the Brexit referendum vote.
Jukes has worked with CVMP for years, first as a member of the committee’s Efficacy Working Party, more recently as its UK representative. In recent years, Jukes has also chaired CVMP’s Antimicrobials Working Party. This résumé makes Jukes well equipped to serve as vice chair of CVMP, but her three-year term will play out against a backdrop of Britain renegotiating its relationship with the European Union.
While Jean-Claude Juncker emailed the 1,126 Britons who work in the European Commission on the day following the Brexit vote to reassure them their jobs are secure, the perception, at least among some in that organization, was that opportunities for people from the UK to gain promotions or get hired in the first place would dry up.
As a senior British diplomat at the Commission put it to the i: “Why would anyone put a Brit in any kind of position of responsibility now when there are 27 other nationalities to choose from whose governments are actively lobbying to ensure they are well represented throughout the administration?”
At CVMP, at least, that skepticism has proven to be unfounded so far.
CVMP Statement, Jukes’ CV, the i
CVMP has released a draft concept paper on the collection of data on antimicrobial use in animals. The concept paper is part of an attempt to harmonize data collection practices across the European Union. This is seen as necessary if the European Surveillance of Veterinary Antimicrobial Consumption is to collect data that can support valid analyses of antimicrobial use. Concept Paper
MHRA has issued a warning about a possible interaction between the antidepressant citalopram and cocaine. The warning follows an investigation into a death from a subarachnoid hemorrhage that is thought to have resulted from an interaction between the drugs. MHRA is telling doctors to consider asking about illegal drug use when prescribing citalopram. MHRA Alert
The Irish governmentis claiming a revised drug price and supply deal it has struck with the industry will save it €200 million ($220 million) a year. Pharmafile
Tags: European Regulatory Roundup, Novartis, adverse events