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Posted 12 March 2015 | By Nick Paul Taylor, Michael Mezher
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The European Medicines Agency (EMA) has updated its Q&A document for marketing authorization applicants with new information on good clinical and laboratory practices (GCPs/GLPs). Applicants should now have a clearer idea of the information they need to provide to the regulator.
EMA updated three documents — which cover generics, biosimilars and pre-authorization in general — with the same text. The new section tells companies what GCP and GLP inspection-related information they should include in applications as annexes to their cover letters. With regard to GCP, EMA wants to see a list of conducted or planned regulatory inspections at all of the clinical trial sites included in the submission. Analytical facilities used for bioequivalence studies must also be included.
The regulator has also requested the inclusion of a table summarizing details of preclinical studies and the facilities at which they were performed. EMA wants to know if the facilities were located in the European Union or an Organisation for Economic Co-operation and Development (OECD) Mutual Acceptance of Data GLP monitoring program at the time of the tests. The Q&A document for generics was also updated to include a link to a list of questions about periodic safety update reports (PSURs). (Nick Paul Taylor)
Generic Q&A I Biosimilar Q&A
The United Kingdom has set out the areas of focus for its review into medical innovation. Sir Hugh Taylor is tasked with leading the review, which will assess the ways in which regulations can cut the time it takes for new medicines to reach patients.
Potential reform of regulation in the UK sits alongside an assessment of reimbursement and drug uptake as one of the three pillars of the review. The panel will assess ways to improve the Early Access to Medicines Scheme (EAMS) — particularly with regard to how it integrates with the National Institute for Health and Care Excellence (NICE) — and look at what the UK can learn from the US Food and Drug Administration’s (FDA) “breakthrough” designation and other initiatives.
At the end of the review, the panel will make recommendations for how the government can cut development timelines over the next 10 years. The panel has the option to propose changes to NICE and the Medicines and Healthcare products Regulatory Agency (MHRA), but the current five-year Pharmaceutical Price Regulation Scheme (PPRS) is untouchable. (Nick Paul Taylor)
Press Release I Terms of Reference
Investigative reports by Der Spiegeland De Standaardhave criticized the pharmaceuticals industry’s involvement in the European Union’s Innovative Medicines Initiative (IMI). The article argues that for-profit industry is given too much control of research from the initiative, which is designed to accelerate drug development.
IMI has responded to its critics, saying that the “biggest challenges in medicine cannot be tackled by any company, organization or even country alone.” The organization defends its collaborative approach and says it is important to have input from relevant stakeholders, including industry, universities, small- and medium-sized enterprizes (SMEs), patient groups and regulators.
Additionally, IMI clarifies that the public funding for the initiative only goes to universities and SMEs (which only receive about 17% of the public funding), and says “large pharmaceutical companies do not receive any IMI funding, but contribute to the projects with their own resources.”
The European Federation of Pharmaceutical Industries and Association (EFPIA) also responded to criticisms about oversight of IMI funding, stating that EFPIA members are not audited by the Court of Auditors because they do not receive funding from the initiative. (Michael Mezher)
Der Spiegel, De Standaard, IMI Response, EFPIA Response
EMA’s Committee for Medicinal products for Human Use (CHMP) has released final guidance on biosimilars containing recombinant human insulin and insulin analogues. The adoption of the document ends its long gestation period, which began in November 2012.
During 27 months, including two rounds of public feedback, since the draft was first released for consultation, the document has undergone significant changes. The final version includes a more detailed discussion about how to approach in vitro pharmacodynamic studies, as well as an introduction to the application of a risk-based model to in vivo tests. Neither featured in the November 2012 draft.
EMA has also reworked the section on clinical trials of insulin biosimilars. The regulator has added a line about when it is appropriate to enroll healthy volunteers in insulin clamp studies and revised the section explaining how to do such tests, dropping some sections from the earlier draft while expanding in other areas.
The final guidance is due to come into force on 1 September, at which time it will replace the version adopted by CHMP in 2006. EMA updated the guidelines as part of its look back at the first wave of biosimilars documents. (Nick Paul Taylor)
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has begun a campaign to counter criticisms of the Transatlantic Trade and Investment Partnership (TTIP). EFPIA argues TTIP is a positive for patients and the economy, not the drug price-raising, regulatory standard-lowering force described by critics.
Officials at EFPIA put their case across in two documents, the first of which lists eight ways TTIP may help patients, healthcare systems and the economy. The points include an explanation of how mutual recognition of production plant inspection reports could save regulators money and why this would result in particular benefits for small and medium-sized enterprises. Other possible benefits include shorter regulatory approval timelines and a more transparent pricing and reimbursement process.
The second document is a point-by-point response to some of the common criticisms of TTIP. While many argue TTIP will drag down regulatory standards in Europe, EFPIA sees this as a myth, stating “there is no intention to lower regulatory standards.” EFPIA makes similar counterclaims to seven other “myths,” including the belief TTIP will hold back the trial transparency initiative and delay the introduction of generics. (Nick Paul Taylor)
TTIP Benefits I TTIP Myths
The United Kingdom has accepted Merck’s anti-PD-1 melanoma drug Keytruda into its early-access scheme, EAMS. Keytruda is the first drug to be accepted into EAMS, which the UK set up to allow patients to access certain therapeutics before they are licensed in Europe.
MHRA based its decision on data Merck generated in a Phase Ib trial, which also formed the core of the submission to FDA that led to the approval of Keytruda in September. While EMA is still reviewing the data ahead of a possible approval, the MHRA decision means advanced melanoma patients in the UK will not have wait for a Europe-wide approval to access Keytruda.
Other drugs could soon follow the path pioneered by Keytruda. MHRA has already given a small clutch of development-phase drugs its Promising Innovative Medicine (PIM) designation, which is the first status a product must attain if it is to be accepted into the early-access scheme. (Nick Paul Taylor)
The Institute for Quality and Efficiency in Health Care (IQWiG) has completed its early benefit assessment of Novartis’ diabetes drug Galvus. The assessment found the drug does not provide any added benefit over comparator therapies. IQWiG found the data of the clinical trial used to compare the drug to another long-acting insulin product provided inconclusive results, saying “It is uncertain that the effects observed are attributable to the drugs used. They might instead have been caused by the therapeutic strategy alone.”
When conducting its added benefit assessment for Gilead’s new hepatitis C (HCV) combination Harvoni (ledipasvir + sofosbuvir), IQWiG found “a hint” of added benefit for two of the seven patient groups presented in the dossier. IQWiG took issue with the fact that the dossier did not contain any direct comparison studies, and instead relied on historical comparisons using data from multiple studies.
The historical studies did show a “dramatic effect” for patients with the most common HCV genotype, with nearly 100% of patients treated with Harvoni reaching a sustained virologic response (SVR) after treatment. The comparator therapies only presented SVR rates of 35% and 75%. However, because no direct comparisons were conducted, IQWiG says it cannot draw a clear conclusion as to the extent of the benefit.
The German Federal Joint Committee (G-BA) will have final say on the extent of the added benefit for each product when it conducts its review of their dossiers and IQWiG’s assessments. (Michael Mezher)
IQWiG Press Release
The European Medicines Agency (EMA) released a document that aims to explain how it calculates and collects fees for its pharmacovigilance activities. EMA began collecting procedure-based fees in August 2014, following the adoption of Regulation (EU) No. 658/2014. Annual fees to the agency will be collected on 1 July 2015, and will be due on the same date each year from then on.
EMA will use the procedure-based fees to reimburse national regulators for their efforts in reviewing periodic safety update reports (PSURs) and pharmacovigilance-authorization-safety-study (PASS) protocols and results. The agency will use annual fees to fund pharmacovigilance activities required under 2010 pharmacovigilance legislation. (Michael Mezher)
EMA Press Release, Explanatory Note
On Tuesday, an Irish court ruled that portions of the country’s Misuse of Drugs Act 1977 that were added through ministerial order are unconstitutional, as they were not reviewed by both houses of Parliament prior to being instituted. This means that certain drugs, such as ecstasy and hallucinogenic mushrooms, added to the act are legal to possess—at least until an emergency measure passed by Parliament and signed by the president on Wednesday can take effect. (Michael Mezher)
Court of Appeal Ruling, National Public Radio, The Guardian
The European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) has proposed extending legislation to standardize the production of medicated feed to cover products for non-food-producing animals. ENVI thinks the change is needed as it is important to limit the use of medicated feed containing antimicrobials in all animals, not just those raised for food. ENVI Opinion
EMA has revised the template for pediatric investigation plans (PIPs) of allergen products for specific immunotherapy. The document states companies can now apply for the prevention of asthma indication if the long-term data support such disease modification. EMA has tweaked a couple of other sections to add references to asthma prevention and disease modification. PIP Template
The European Union has released the final report about a vaccination conference held late last year. The report summarizes a speech made by the former executive director of EMA, Guido Rasi. In the speech, Rasi discussed the vigilance that regulators, manufacturers and public health officials must display to stop occasional reports of adverse events denting peoples’ trust in vaccines. Final Report
Swissmedic has put a contract to run its pharmacovigilance system out to tender. The regulator introduced the Electronic Vigilance Reporting Portal (ElViS) in October and is now seeking a service provider to manage the system from the start of next year. Swissmedic Notice (German)
Tags: EU Regulatory Roundup, European Regulatory Roundup, Regulatory Roundup
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