RAPS News: Europe provides a monthly snapshot of important news and developments that impact the healthcare product regulatory environment, with a particular emphasis on Europe.
RAPS
RAPS will host a two-day programme in Brussels next month devoted to examining recent revisions to the legal framework governing the regulation of medical devices and technology throughout Europe, the EU's Medical Devices Directives (MDD). Titled Medical Devices Directives: Lessons Learned and the Way Forward, the event will take place at the Radisson Blu Royal Hotel in Brussels, 18–19 November. Among the speakers will be officials from the European Commission; Eucomed; Swissmedic; and the Dutch Ministry of Health, Welfare, and Sport. Philippe Auclair, PhD, senior director, regulatory strategy and advocacy, Abbott Quality and Regulatory EMEA, Abbott Vascular International, and Rainer Voelksen, executive, international regulatory affairs, GE Healthcare EMEA developed the event and will serve as lead faculty. "With recent changes in regulations and the planned 'recast' of the Medical Devices Directives, the European medical device landscape is changing rapidly, and major impact is expected for the medical technology industry. All regulatory professionals involved in European regulations must be aware and prepared for these changes," said Auclair. "RAPS has brought together a highly respected group of regulators, stakeholders and thought leaders for this conference to help attendees further develop deep understanding of the law's implications and be better prepared to respond strategically to its challenges and opportunities." Experts in attendance will address the revised MDD, Directive 93/42/EC (via Directive 2007/47/EC) that took effect in March 2010 and facilitate discussion on critical topics including the European Commission's Eudamed Decision 2010/227/EU, clinical investigation changes and market surveillance.
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Reuters
European regulators will define requirements for copies of antibody drugs in November, laying the foundation for generic competition in a multibillion-euro market that includes treatments for cancer and immune system problems. European Medicines Agency (EMA) Executive Director Thomas Lonngren says guidelines on biosimilar monoclonal antibodies would be published after being reviewed by the agency's expert committee on drug approvals in November. The highly anticipated guidelines will be open for three to six months of external consultation before being formally adopted, most likely in the second half of 2011. So far, complex biotech medicines have been generally immune from generic competition, unlike conventional medicines like pills and capsules. However, industry regulation is changing, and Europe has already approved 13 biosimilars, including copies of human growth hormone, anaemia treatment EPO and G-CSF against low white blood cell levels. EMA has already received requests for scientific advice on six biosimilar antibodies, a relatively small number that reflects the difficulties of making such copycat medicines. "This is much more complicated than the normal generic business, so it will be a lot of work for these companies," says Lonngren, who expects about two or three applications a year. As with the existing biosimilar drugs approved by EMA, generic drug companies must conduct clinical trials to prove their antibodies are similar to the original products. US regulatory preparations for biosimilars are further behind than in Europe, but leading generic drug makers are looking for opportunities in both markets.
PharmaTimes
The European Parliament has voiced its support for increasing Europe's pharmacovigilance systems, which would make reporting adverse events easier and help identify treatments that need special monitoring. The Pharmacovigilance Directive, which has been approved by the Council of Ministers and the European Parliament's Public Health Committee, will enable the EU and Member States to establish pharmacovigilance websites and national web portals that will feature assessment reports, summaries of product characteristics and patient information leaflets. The portals will provide instruction on how to report any suspected adverse reactions. The portals will be connected to the EU Eudravigilance database, which will be a single point of receipt for all pharmacovigilance information, and will be fully accessible to Member States, the European Medicines Agency and the European Commission, and appropriately accessible to doctors, the public and the pharmaceutical industry. Czech Member of Parliament (MEP) Jiri Mastalka says the new law will ensure the independence of Competent Authorities and the sustainability of their budgets, and will help guarantee that decisions on patients' safety are not "unduly influenced" by commercial interests and other factors. Brian Ager, director-general of EFPIA, the European research-based pharmaceutical industry body, says this effort is only part of a pharmaceutical package that was announced in 2008, and went on to urge MEPs to act decisively on other areas of the legislation. The European Parliament later rejected a proposal to allow pharmaceutical companies to publish information about their medicinal products in print publications aimed at consumers. Members of Parliament's Environment Committee voted instead to emphasise patients' rights, introducing a new article into the legislation that requires Member States to ensure that "objective, unbiased information" is publicly available.
International Medical Device Regulatory Monitor
While the European Commission (EC) makes no policy recommendations banning the reuse of single-use devices (SUDs) in its final report on reprocessing devices, devicemakers are welcoming the agency's acknowledgement of the risks involved. "The EC report confirmed that even with all the evidence and scientific opinion available, 'it is not possible to quantify the risk associated with the use of reprocessed single-use medical device[s],'" Eucomed said. Eucomed had asked the EC to adopt EU-wide measures preventing the reuse of SUDs. The trade group noted that France, Italy, Portugal and Spain have implemented a ban on the practice. The EC report cites three major hazards associated with reprocessing: lingering contamination, chemical residues from reprocessing and possible effect on device function. But not all SUDs are suitable for reprocessing, according to the report. For example, needles and angioplasty catheters are not designed to withstand reprocessing. While manufacturers are not required to provide reprocessing instructions or have a validated process, they should provide information on known risks if their devices are reused, the report recommended. The 2007 revision of the Medical Devices Directives required EC to study the issue and produce a report by 5 September. Eucomed says it expects the EC to propose additional legal measures to ensure the safety of SUDs.
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PharmaTech.com
The European Medicines Agency (EMA) recently discussed the possibility of creating a global framework for clinical trials, largely because most clinical trials for medicines approved in Europe are conducted outside EMA's regulatory authority. "Wherever in the world we stand, the majority of clinical trials are being conducted somewhere else in the world, under a different regulatory framework and in different cultural settings. However, we all rely on the same trials to make decisions," says EMA Head of Inspections Fergus Sweeney. EMA reports that only 38.8% of patients enrolled in important clinical trials between 2005 and 2009 received their treatments in the EU and European Economic Area. "What is needed is a robust framework for the oversight and conduct of clinical trials, no matter where in the world the clinical investigator's sites are located and patients recruited. The agency is committed to build and extend its relationship with regulators in all parts of the world and with international organisations to work to standards agreed and recognised by all," says EMA Executive Director Thomas Lonngren. EMA's discussion on a global framework for clinical trials was part of a workshop intended to address the need for safe, global clinical trials. The workshop set forth three major strategies for achieving this objective; cooperation and networking between regulatory authorities and ethics committees involved in supervising clinical trials, greater transparency of clinical trials, including patient registers and the provision of information about ethical and good clinical practice aspects, and involving patients early in trials intended to ensure adequate protection.
