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 | 28 January 2016 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The European Medicines Agency (EMA) has called for the establishment of a harmonized definition of a medicine shortage after meeting with the industry to discuss the development of proactive approaches to preventing shortages in supply.
Officials at EMA left the meeting with a strong belief in the importance of harmonized, industry-wide terminology and a common understanding of how supply disruptions evolve. Almost two-thirds of member states lack a definition of a medicine shortage, and there is a little consensus about exactly what the term means, even among the countries that have put their interpretations of the phrase in writing. EMA thinks this lack of harmonization results in the conditions for reporting drug shortages varying across Europe, making it difficult to perform benchmarking and comparisons.
Despite these difficulties, EMA sees enough shared ground on which to build its strategy. “Although there is no harmonized approach to reporting and dealing with shortages, common points could be identified which could be built on to develop common best practices,” the regulator wrote. EMA is looking to start this process by identifying the point at which a manufacturing or quality problem is likely to trigger a significant disruption to supply. Once EMA has located this point, it intends to set a marker for when manufacturers should report a situation that could lead to a shortage.
However, while many member states are in favor of harmonization in some areas, notably shared reporting triggers and data requirements, there is resistance to the concept of all working from the same templates. The use of harmonized reporting templates is seen as overly rigid. Even without the harmonization of these forms, EMA thinks it can establish a system in which information gathering is consistent and responses to changes to the situation are coordinated. EMA plans to establish single points of contact at national and European levels to facilitate such coordinated responses.
The identification of ways in which EMA and member states can work collaboratively to improve the handling of shortages is set to lead to the revision of the agency’s implementation plan. Yet, while the various regulatory groups in Europe can go some way to refining the process, EMA is conscious of the need to involve the industry and its global peers. EMA plans to meet with overseas regulators to identify common points and differences, while also exchanging best practices. The work mirrors the activities EMA has undertaken to learn how approaches to shortages vary across Europe.
A political committee in the United Kingdom is holding an inquiry into the impact of European Union regulations on the local life science industry. The committee is aiming to establish whether the EU is facilitating the industry by harmonizing procedures for research and commercialization, or holding it back through prohibitive or inconsistently implemented regulations.
Specifically, the politicians who make up the committee are hoping to exit the inquiry process with answers to five questions, the first of which covers the identification of the main EU regulations and frameworks that shape life science research in the UK. With this grounding in place, the committee wants to assess the ways in which these regulations and frameworks help and hinder the research organizations it represents.
The remaining three questions address the processes governing the creation and implementation of EU regulations. Officials want to know how “transparent, consultative and evidence-based” the EU is when it comes to drawing up regulations, as well as the extent to which the UK can influence texts and strategies that will affect its life science industry. Finally, the committee is seeking to learn whether the UK can “depart from the application, standards or timing” of EU regulations.
Members of the Science and Technology Committee have initiated the inquiry at a time when the UK is reconsidering its relationship to the EU. Prime Minister David Cameron committed to attempting to renegotiate the terms of the UK’s relationship with the EU during the last election. Before the end of 2017, and potentially as early as June, Cameron has promised to hold a referendum to allow the public to vote on whether to stay in the EU under the terms of the renegotiated relationship.
The committee is far from alone in trying to ascertain the likely consequences of the UK leaving the EU. Many people, from the CEOs of leading pharmaceutical companies to venture capitalists, have expressed concerns that severing ties to the EU would threaten the UK’s status as a regional research hub, primarily because it will make it harder to hire the best scientists from across Europe. Others are worried about the impact of losing EU grants, The Financial Times reports.
Select Committee Statement, The Financial Times
The National Institute for Health and Care Excellence (NICE) has recommended starting rheumatoid arthritis patients who need certain types of treatment on the cheapest of the suitable drugs. In doing so, the UK watchdog has delivered a boost to manufacturers of biosimilar treatments.
NICE has signed off on the use of treatments containing seven different active ingredients in patients with severe rheumatoid arthritis for whom disease-modifying antirheumatic drugs are ineffective. The list of recommended active ingredients includes those found in blockbuster products such as AbbVie’s Humira and Remicade, which is sold by Merck in the UK. Yet, a line in the NICE guidance means these well-established drugs will become fallback options in the care of rheumatoid arthritis.
“Start treatment with the least expensive drug,” NICE wrote in its guidance. At the National Health Service (NHS) list price, Merck’s Remicade costs the UK £10,071 ($14,365) in the first 12 months of treatment and £8,812 a year from then on. The other innovator biologics covered by the guidance, namely Humira, Bristol-Myers Squibb’s Orencia, Pfizer’s Enbrel, Roche’s RoActemra, UCB Pharma’s Cimzia and Merck’s Simponi, all cost similar amounts for a year’s treatment.
Biosimilar copies of Remicade from Pfizer unit Hospira and Napp Pharmaceuticals cost the NHS at list price £9,064 in the first year and £7,931 thereafter. NICE said it has negotiated even lower prices, but is unable to disclose the figures for reasons of confidentiality. At the list price, the biosimilars deliver a relatively small saving, but it is still enough to make them the first treatment option under the NICE guidance.
The guidance is an indication that NICE is amenable to facilitating the uptake of biosimilars, giving developers of innovative drugs that are losing patent protection cause for concern. Merck is already discounting Remicade in an attempt to maintain market share in the face of biosimilar competition. With Samsung Bioepis winning European approval for a copy of Pfizer’s Enbrel earlier this month, the pressure to compete on price is set to intensify.
NICE Guidance, Reuters
EMA has held its first annual bilateral meeting with the European Generic and Biosimilar Medicines Association (EGA). The meeting took place in London this week. EMA held the closed gathering as part of its program of annual bilateral meetings with industry stakeholder organizations, at which it discusses topics of common interest with different groups. EMA Alert
Tags: EMA, drug shortages, NICE, EGA