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.
Reuters
European regulators have adopted a new guideline on biosimilar antibody drugs, laying the foundation for cheaper versions of expensive medicines to treat cancer and other serious diseases. The European Medicines Agency (EMA) did not immediately publish the full document, but has since released it on its website. The regulations are highly anticipated by drug companies and investors, who want to know how difficult or expensive it will be to win approval in Europe for copies of complex antibody-based drugs. EMA simply stated, "This guideline lays down the non-clinical and clinical requirements for monoclonal antibody-containing medicines claiming to be similar to another one already marketed." Industry experts are generally anticipating a cautious approach, requiring separate clinical trials for different diseases addressed by the same antibody, which would be good news for the original producers of monoclonal antibodies. However, for manufacturers of generic drugs, a cautious approach to approval would raise costs and may limit the market to a few sophisticated and well funded companies.
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Medical News Today
In response to rising public demands for more transparency, the European Medicines Agency (EMA) has adopted a new policy that allows more access to its documents while continuing to protect confidential commercial data. Once a procedure pertaining to a medicine is finalised and the decision-making process is complete, the documents relating to that medicine will be released, EMA said. This pertains to all business-related documents unless there have been privacy agreements with non-EU regulators and organisations or if the privacy of a person would be affected. The rules also include clinical trial reports and other documents submitted as part of a marketing authorisation, and if a document is only partially sensitive then the confidential sections will be redacted and the remainder released. In the first phase of the policy's implementation, documents will be released in response to written requests, and in the final phase the documents will be available via the electronic register.
PharmaTech.com
The European Medicines Agency (EMA) has published a draft list of questions and answers on postapproval change-management protocols. Postapproval change-management protocols were introduced by the European Union in 2008. The new Q&A is intended to outline general principles for using and implementing the protocols. The document defines a postapproval change-management protocol as specific changes that a company would like to make during the lifecycle of a product, and how these would be prepared and verified. The document states that drug manufacturers should submit to EMA, as part of a Marketing Authorisation Application, any relevant data needed to demonstrate that they have obtained adequate knowledge to prepare and manage the effects of the change. For example, the protocol could include a risk assessment of the effect of the change on product quality and a description of the studies to be performed to analyse the effect the proposed change would have on product quality. The Q&A also addresses how and when the change should be implemented once EMA approves the protocol, noting that the types of changes to include in the submission would depend upon the complexity of the product and the manufacturing process, among other factors. In June, the US Food and Drug Administration (FDA) issued a draft guidance on chemistry, manufacturing and controls postapproval manufacturing changes. The FDA draft guidance largely focuses on changes that are considered to have a minimal effect on product quality and can therefore be reported to the agency through annual reports.
Bloomberg
European drug regulators will make thousands of pages of clinical trial reports public, due to pressure from drug-safety activists and concern over suicide risks linked to a failed diet pill. The European Medicines Agency (EMA) will provide data upon request of every drug it has reviewed, says EMA spokesperson Sabine Haubenreisser. The agency plans to publish the reports on its website within five years, according to EMA Executive Director Thomas Loenngren. "We are becoming more transparent," says Loenngren. "We also have a huge pressure on us to be more transparent. This is a challenge for all of us in the future." The quick release of the full trial reports for all drugs approved or rejected would be a more aggressive policy than the policy in the US, where law requires summary results of trials underway by September 2007 to be reported for products approved by the US Food and Drug Administration. EMA will not require drugmakers to disclose data determined to be commercial or confidential, like manufacturing information, says Loenngren. Several obesity and weight loss pills have recently come under scrutiny. Meridia was pulled from European markets in January, and US markets in October, and Acomplia was pulled by the European regulator in October of 2008. The push for greater access to clinical trial reports was largely due to researchers arguing that the full reports may contain more information than the reports published in public.
FDA Week
An industry-backed survey of small device manufacturers reports a growing discontent with the US Food and Drug Administration (FDA) review process, and shows that device approvals in the US are falling behind approvals in Europe. The survey supports developers' complaints that recent reviews, including the 510(k) clearance process, have been inconsistent and discourage submissions for products. The results of the survey have prompted industry groups to call on FDA to improve the transparency and consistency of the approval process. However, patient safety advocates argue that there are other factors in Europe that contribute to the discrepancy between the US and EU systems. The Advanced Medical Technology Association called the report a wake up call, and urged FDA to improve reviewer and manager training, develop specific guidance for product types, improve the de novo process, and develop specific metrics to improve consistency. The study reports that it took three months to two years longer for low- and moderate-risk devices, usually cleared through the 501(k) process, to enter the US market, compared to the European market. High-risk devices, which usually undergo premarket approval review, took three and a half years longer, according to the review. The majority of survey respondents said FDA also lagged behind EU authorities in predictability, reasonableness and transparency. A common problem was key personnel missing scheduled meetings or changing over the course of the approval process, which cause delays and inconsistencies because Read more » (subscription required)
