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Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The European Medicines Agency (EMA) has released a concept paper outlining its plans to update annex 1 in response to Q9 and Q10 guidelines from the International Conference on Harmonisation (ICH). In its current form, annex 1 covers good manufacturing practices (GMPs) for sterile products.
The major changes relate to regulatory and technological advances since annex 1 was last updated in 2007. ICH Q9 and Q10 outline the technologies and approaches companies can use to implement risk management and establish a modern quality system, but neither is incorporated into annex 1. The EMA update will clarify how producers can use the tools and techniques described in Q9 and Q10.
EMA also plans to formally extend the mandate of annex 1 to cover some non-sterile finished drugs and the early stage of manufacturing of multiple products. The current guidelines are already used for such products, but this is unclear from the title. EMA also intends to remove some historical inaccuracies and clarify areas of ambiguity in annex 1.
The process is just getting started. EMA is accepting comments on the concept paper until 31 March, after which the Pharmaceutical Inspection Co-operation Scheme (PIC/S) will convene to discuss the plan. The aim is to release draft guidelines for consultation in October and reconvene the PIC/S committee to discuss feedback in July 2016.
EMA has defended the process it used to redact information from clinical study reports (CSRs) relating to AbbVie’s Humira, but has admitted that it incorrectly removed some details. The regulator said the need to review “massive amounts of documents” on a tight deadline led to the erroneous redactions.
Deputy Executive Director Andreas Pott outlined EMA’s approach to redactions in a four-page letter to European Ombudsman Emily O’Reilly, who asked the regulator for details in October 2014. The meat of EMA’s response is found in the seven-page annex attached to the letter, in which the regulator answers each of O’Reilly’s questions in turn.
In response to aspects of more than half of O’Reilly’s questions — many of which contained multiple sub-queries — EMA admitted it made a mistake by redacting the document. EMA told O’Reilly the workload caused the mistakes, adding that AbbVie made no objection when the release of the information was proposed.
However, for many of the redactions EMA thinks it made the right decision. In some cases, it has since released details, an approach that fits with its belief that the confidentiality of data changes over time. Subgroup analyses related to the dosing of Humira in various populations fall into this category. The analyses were initially redacted as they were relevant to ongoing development but shared later.
O’Reilly is now reviewing EMA’s responses and will decide how to proceed as soon as possible, a representative told Pharmalot. The outcome has implications for the clinical trial transparency agenda in Europe, for which the definition of confidential information has become a contentious topic.
EMA Letter I Press Release I Pharmalot
The European biopharma industry has stepped up its opposition to Italy’s reimbursement of off-label drug use by filing a complaint with the European Commission, PharmaTimes reports. The complaint comes eight months after the European Federation of Pharmaceutical Industries and Associations (EFPIA) criticized the Italian policy publicly.
EFPIA has joined with the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European Association for Bioindustries (EuropaBio) to make the complaint. The trio claim Italy’s law promotes the off-label use of drugs solely for economic reasons, an allegation that centers on the use of Roche’s cancer drug Avastin to treat wet age-related macular degeneration.
Novartis’ Lucentis is approved in the indication but is more expensive. Italy has led the charge to use Avastin instead of Lucentis by agreeing to reimburse the former and fining their manufacturers €182.5 million ($207 million) for allegedly colluding on the products’ availability. The industry has now bitten back by accusing Italy of putting patient safety at risk and going against the European Court of Justice.
EMA’s Biosimilar Medicinal Products Working Party (BMWP) has revealed it plans to publish three concept papers on similar biological products in the second quarter of 2015. The papers will start the process of updating a trio of biosimilar guideline documents EMA published in 2005 and 2006.
BMWP outlined the timeline in its work plan for 2015. The concept papers cover biosimilars containing either recombinant granulocytecolony stimulating factor or recombinant interferon alpha, plus immunogenicity assessments for biotechnology-derived therapeutic proteins. EMA covered each topic in its first wave of biosimilar guidance documents.
The regulator has gone back over the documents in recent years, leading to the publication of revised draft guidelines on several topics in 2014. BMWP expects to publish final guidelines on two of the revisited topics — recombinant human insulin and low-molecular-weight heparins — in the first half of 2015.
BMWP Work Plan
EMA’s Committee on Herbal Medicinal Products (HMPC) has called for scientific data to support the review of two monographs and released another pair of draft documents for consultations. The actions will lead to revised monographs for St John's wort, devil’s claw and two forms of bilberry.
HMPC’s review of the monographs of St John's wort and devil’s claw is still at the data-gathering stage. The regulator is seeking data from trade groups and other institutions to inform its revision of the traditional and well-established medicinal uses of the herbal products. St John’s wort is used to treat depression and other mental health issues, while devil’s claw is taken for osteoarthritis.
The regulator has also released draft monographs for fresh and dried bilberry for consultation. HMPC found no well-established medicinal uses for either form of bilberry, which is traditionally taken to treat mild diarrhea and leg discomfort. The public can comment on all four of the documents until 15 May.
St John’s Wort I Devil’s Claw I Dried Bilberry I Fresh Bilberry
Swissmedic has identified three products it has authorized for export on the list of GVK Bio-tested drugs at risk of suspension. None of the 700 products are on sale in Switzerland. The manufacturers of the three drugs authorized for export by Swissmedic must now share information with the regulator, after which it will decide whether it needs to suspend or withdraw the licenses. Press Release
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has warned companies someone is calling up businesses and pretending to be one of its staffers. If companies have any doubts about whether a caller actually works for MHRA, the regulator advises them to check by contacting its customer services line on 020 3080 6000. MHRA Statement
Medecins du Monde has mounted a legal challenge against the European patent for Gilead’s hepatitis C blockbuster Sovaldi. The nonprofit claims Gilead is charging “exorbitant” prices for a drug that “is not sufficiently innovative to warrant a patent.” The patent challenge comes weeks after an Indian court rejected Gilead’s application. A European decision could take years. Bloomberg.
Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup