Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Ex-Executive Director Rasi Offered Advisory Role at EMA
EMA has tried to lessen the fallout from the loss of its executive director Guido Rasi by offering him the role of principal advisor in charge of strategy. Rasi was ousted in November 2014 when a court found fault with the selection procedure that led to his hiring.
In the months since the court’s decision, Rasi has remained under contract at EMA but has not been able to lead the organization. EMA now plans to amend Rasi’s contract to make him principal advisor in charge of strategy, a role for which he is well-suited. Rasi led the reform agenda at EMA during his time as executive director, raising concerns that initiatives could stall in his absence.
The creation of an advisory role for Rasi could smooth the transition by preventing the loss of his knowledge of and experience with the reform programs, such as the establishment of a clinical trial portal. EMA discussed the portal at the same meeting at which it revealed its plans for Rasi. An update on timelines for developing and deploying the system is due in March.
Regulators Prepare for Busy 2015 After Uptick in Approvals Last Year
The European Medicines Agency (EMA) is predicting it will receive a similar number of applications for initial marketing authorization in 2015 as it did last year. In 2014, the regulator received 118 applications and approved 82 innovative and generic medicines.
The number of approvals represents a slight uptick compared to 2013 — when the regulator cleared 79 drugs — and a considerable increase relative to 2012, Reuters reports. EMA is forecasting a similar workload for 2015. The regulator expects to receive 114 applications for initial marketing authorization, of which 24 are projected to be for rare diseases. Both numbers are very similar to the comparable figures for 2014.
EMA will have more money to spend on performing its duties. The budget for 2015 is €302 million ($360 million), an increase of 7% over last year. EMA attributed the budget increase to a rise in the number of applications and the receipt of pharmacovigilance fees. EMA typically derives more than 80% of its budget from fees and charges.
The money will go toward supporting the expanding range of activities at EMA. In 2015, the regulator expects to handle more requests for scientific advice on clinical development. Some of these requests will entail working alongside health technology assessment (HTA) bodies — such as National Institute for Health and Care Excellence (NICE) — to cut the lag between approval and reimbursement of drugs.
ReutersI EMA Notice
EMA Posts Ad for Executive Director Vacancy
EMA has posted a recruitment notice for the position of executive director. The ad calls for people with experience of leading multicultural organizations the size of EMA and detailed knowledge of European pharmaceutical legislation to apply for the position by 28 January.
The vacancy notice is the first step in a long appointment process, which is likely to face even greater scrutiny than usual because of the faults a court found with the selection of the previous executive director. Applicants with the most promising profiles will go through a multi-step interview with the European Commission, which will lead to shorter and shorter lists of candidates.
Once the commission has its final shortlist, the EMA management board will interview the candidates and make its selection. The last step is for the management board’s favored candidate to address the European Parliament and answer its questions. The successful applicant will receive a five-year contract, which can be renewed once.
EMA Vacancy Notice
Manufacturers Mount Legal Challenge to German Ban on GVK-tested Drugs
The German Federal Institute for Drugs and Medical Devices (BfArM) has encountered resistance from certain manufacturers to its attempt to ban generic drugs tested by GVK Biosciences. BfArM had tried to bar the sale of 80 products, but allowed 18 drugs to remain on sale after their manufacturers began a legal challenge against the enforcement action.
While many of the manufacturers appear to have accepted the ban, others — notably Betapharma — have fought back against the regulator, the Press Trust of India reports. Most of the drugs excluded from the ban are sold by Betapharma, a German generics manufacturer acquired by Dr. Reddy's Laboratories in 2006.
The rest of the companies affected by the ban must present BfArM with new data if they wish to resume selling the products. For now, regulatory actions against GVK-tested drugs are limited to Germany, France, Belgium and Luxembourg, but the situation could escalate later this month when EMA delivers its recommendation on the validity of the marketing authorizations.
Press Trust of India
EU Committee Warns TTIP may Lower Regulatory Standards
The Committee on the Environment, Public Health and Food Safety (ENVI) has said it is worried about the consequences of the Transatlantic Trade and Investment Partnership (TTIP). ENVI joined the backlash against the trade agreement in its contribution to recommendations to the European Commission.
Regulations are at the heart of the concerns. ENVI thinks the creation of a Regulatory Cooperation Council will lower certain standards in Europe. The concerns are underpinned by a belief that the United States has laxer regulations in certain areas. As such, any transatlantic regulatory convergence could move standards in Europe down a notch.
ENVI supported European Commissioner for Trade Cecilia Malmström’s request that areas in which Europe and the US have particularly divergent regulations are excluded from the TTIP negotiations.
NICE Updates Position on Biosimilars as Copycats Near Mainstream
The United Kingdom’s NICE has revised its approach to biosimilars ahead of an anticipated surge in use of such products. Biosimilars will typically be assessed as part of Multiple Technology Appraisals alongside their reference products.
NICE may also produce an “evidence summary new medicine” for biosimilars if it is deemed necessary, but has already stressed it will not recommend whether physicians should prescribe the originator or copycat product.
The guidance also lays out NICE’s approach to the thorny issue of biosimilar names. Technology appraisals will use the name of the active drug substance, as well as the brand of the reference product and biosimilar.
The Committee for Medicinal Products for Human Use (CHMP) has published draft guidelines on clinical trials of recombinant and human plasma-derived factor IX products. The draft is a lightly revised version of guidelines EMA adopted in 2012. CHMP has added a section on measuring potency in light of a workshop held in 2013. Draft Guidelines
EMA has released a report on its adaptive pathways pilot project. The report reveals EMA had received 34 requests as of December 2014, six of which were for advanced-therapy medicinal products. The second stage of the pilot project is due to start next month. Press Release
Denmark’s Ministry of Health has changed the fees medical device companies must pay. The new fees apply to the registration of manufacturers, importers and distributors, as well as the assessment of applications for clinical trials of medical devices. Regulatory Notice
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has named Dr Janet Valentine as director for The Clinical Practice Research Datalink (CPRD). MHRA Notice