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    European Drug Prices: New Commission Report on What Policies Work and What Could Work

    The complicated world of drug pricing presents an array of challenges for keeping costs low in the US and EU, though European countries are increasingly employing new policies to keep price gouging in check. The 260-page report on drug pricing in Europe, released Thursday by the European Commission, looks into two policy options: external price referencing (EPR), which is predominantly a tool for medicine price control and currently employed across the region, and differ...
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    Registration Procedures for Medicinal Products in China

    This article provides a high-level introduction to the Chinese regulatory framework, including requirements for marketing approval of imported drugs. An increasing number of pharmaceutical companies based outside China are interested in marketing their products in China as evidenced by the increasing number of clinical trial and marketing applications submitted by foreign companies. Obtaining marketing authorization approval equal to an Import Drug License (IDL) approv...
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    Pharmaceutical Marketing via Social Media

    This article discusses the ongoing effort by the pharmaceutical industry to use social media as a marketing tool. It presents benefits and limitations of using this form of media and describes recent progress in public communication. Pharmaceutical marketing is the practice of promoting and selling medicines to patients through different media. The broad scope of this definition encompasses all means for the purpose of marketing and sales adopted by a company. A drug c...
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    FDA to its Scientists: Feel Free to Engage on Social Media

    The US Food and Drug Administration (FDA) is now encouraging its employees to use social media in a personal capacity, particularly for sharing information that may benefit public health, as long as employees make clear that their opinions aren’t the views of the agency. The new policy, released last week, clarifies that employees do not need to obtain permission or approval from FDA supervisors or agency management to use social media in a personal capacity, although “e...
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    Walking the Digital Tight-Rope

    On behalf of the Regulatory Focus Board of Editors, we would like to introduce you to a collection of articles on the regulatory oversight of advertising, labeling and social media. Most likely, you are currently reading this on your iPad, smart phone or computer screen as are the majority of people seeking information in this digital-age. To align with current user-practices, Regulatory Focus magazine moved to a completely digital format in 2012. Along the same vein,...
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    FDA Social Media Guidance–Lessons Learned from the Comment Period

    This article reviews and summarizes public comments on FDA's two draft social media guidance documents. In the past, traditional drug and device promotion came in the form of paper collaterals–sales aids, booth panels, slim jims* and the like. As we entered the internet age, companies found new avenues to get their product promotional messages out. Broadly defined as "social media," new forms of product communication now include interactive websites with sharing capabi...
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    US, EU Face Off Over Permanently Exempting Least-Developed Countries from Pharma Patents

    Tomorrow and Friday, members of the World Trade Organization (WTO) will meet to discuss whether the world's poorest countries should be permanently exempt from rules governing pharmaceutical patents, and the EU and US have publicly taken separate sides. Background Since the initial WTO agreement on Trade-Related Aspects of IPRs (TRIPs) in 1995, least-developed countries (LDCs) have been granted exemptions from implementing intellectual property (IP) rules for pharmaceut...
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    Social Media: Changing the Rules for Regulatory Professionals

    This article discusses social media's role in the changing regulatory landscape and how regulatory professionals must evolve to ensure compliance with FDA requirements specific to the medical device field. As social media rapidly evolves via the internet, digital media platforms, new technologies and mobile applications enhancing the marketers' ability to create and deliver more personalized, segmented solutions to medical device users, regulatory professionals also ne...
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    The Evolving Approach of Presenting Risk Information to Consumers

    This article discusses an evolving approach to present prescription drug risk information to consumers based on recent guidances released by the Agency. In recent years, there has been an increased focus from the US Food and Drug Administration (FDA) on consumer directed promotional materials. Nearly all of the active research projects at the Office of Prescription Drug Promotion (OPDP) are focused on how consumers respond to the type or presentation of risk inf...
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    EMA to Publish First Clinical Trial Reports in Mid-2016 Under New Transparency Law

    Following two meetings with drug companies and other stakeholders in July and September, the European Medicines Agency (EMA) says it will publish the first clinical trial reports in mid-2016. The release of the reports comes as EMA's policy on publishing the data came into effect last January. The new policy applies to clinical reports contained in all marketing-authorization applications submitted on or after 1 January 2015, and includes reports where drugmakers hav...
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    EC Calls for Indefinite Exemption from Pharma IP Rules for Least-Developed Countries

    The European Commission on Thursday agreed to support a proposal that would allow the least-developed countries (LDCs) to have easier access to generic drugs via an indefinite exemption from World Trade Organization (WTO) intellectual property rules for pharmaceuticals. The exemption, which must also be approved by the European Council, would allow generic drugs to be imported and manufactured locally, regardless of patents. More simply, the proposal means that manufactu...
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    European Commission Seeks Industry Comment on New GMP Guidelines for Investigational Drugs

    The European Commission is seeking comment from industry on two documents tied to the guidelines and principles of good manufacturing practices (GMP) for investigational drugs. The commission notes that the current GMPs for medicinal products for human use from a 2003 directive are "generally well-functioning," so, "There is no need to reinvent the wheel." The application of GMPs for investigational drugs is intended to ensure that clinical trial subjects are not p...