RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • RAPS' LatestRAPS' Latest

    UPDATE: RAPS Seeks Authors for EU Fundamentals Book Deadline Extended

    • 30 March 2017
    The eighth edition of Fundamentals of EU Regulatory Affairs will be published in December 2017. RAPS currently is seeking authors for chapters, which will be due no later than 1 August 2017. If you would like to contribute to this book, please review the list of currently available chapters below and send your CV and your preferred chapter(s) to Pam Jones, senior editor, at pjones@raps.org or submit a volunteer application online. Emails or applications must be...
  • Regulatory NewsRegulatory News

    EU Court of Justice Denies EMA Appeal to Release Documents on Two Medicines

    The Court of Justice of the EU earlier this month delivered a blow to transparency efforts at the European Medicines Agency (EMA), dismissing two appeals by the regulator. The decision means the court has upheld the suspension of the release of clinical study report documents requested by a pharmaceutical company related to PTC Therapeutics’ Duchenne muscular dystrophy treatment Translarna (ataluren) and three toxicity studies for Intervet’s Bravecto (fluralaner), a vete...
  • Regulatory NewsRegulatory News

    African Union, WHO Team Up to Launch African CDC

    Officials at the African Union Commission (AUC) and the World Health Organization Regional Office for Africa (WHO/AFRO) are looking to address the shortcomings of the international response to the Ebola crisis by launching a new disease monitoring agency, the Centres for Disease Control and Prevention in Africa (African CDC). Background Africa has the world's highest burden of disease , with far higher mortality rates for infectious diseases than any other region. Many...
  • Regulatory NewsRegulatory News

    EU Court Rules on Orphan Product Exclusivity

    A European Court has issued a ruling in an unlikely scenario dealing with overlapping periods of orphan product market exclusivity. In its ruling, which has the potential to influence how companies develop orphan products, the court found that authorized orphan products are entitled to market exclusivity, even when they are similar to an already approved product. Background Orphan product designation was first introduced in the EU in 2000 under Regulation (EC) No 141...
  • Regulatory NewsRegulatory News

    Free the Tweets: Group Asks FDA to Allow its Scientists to Use Social Media

    The US Food and Drug Administration currently lacks any policy permitting its employees to discuss scientific issues on social media channels like Twitter and Facebook, a new report by the scientific advocacy group Union of Concerned Scientists (UCS) has found. The findings, outlined in the report " Grading Government Transparency: Scientists' Freedom to Speak (and Tweet) at Federal Agencies ," are meant to spur discussion about whether FDA's employees are free to speak ...
  • Prominent Consumer Group Petitions FDA for Changes to Device Approval System

    A prominent consumer advocacy group is once again calling for the US Food and Drug Administration (FDA) to make changes to the way it regulates medical devices, saying that the high-profile failure of one implantable medical device is evidence that all others should be classified as high-risk products and held to more stringent testing standards. Background Metal-on-metal hip implants were cleared in recent years through FDA's 510(k) pathway, which allows for companies ...
  • India's Health Ministry Releases New Clinical Trials Requirements

    India's Union Health Ministry has released a new rule requiring all ethics committees to be registered with licensing authorities, part of a broader effort to improve the quality of clinical trials in India, which have long been under fire by critics. Background India's drug regulatory bodies were steeped in controversy in 2012. From the onset, Indian regulators and companies came under fire after media investigations found that clinical trials conducted in the country ...
  • Brazilian Regulators Go On Strike

    Brazilian government officials, including those at the regulatory agency Anvisa, have gone on strike, leaving the agency critically under-staffed and scrambling to make sure its basic operational functions are maintained. Anivsa said in a statement that the Brazilian Supreme Court has ordered it to ensure at least 30% of its work force remains on the job during a  strike of the regulatory agency's workers . Anvisa has reportedly assured industry that the agency...
  • Group Nominates More Than 60 Scientists to Fill Advisory Committee Vacancies

    • 19 June 2012
    Just how hard is it to find un-conflicted experts for the US Food and Drug Administration's (FDA) Advisory Committees? The question is at the heart of a long-running skirmish between FDA, industry, and public interest groups-all of whom have different interpretations regarding how easy it is to find unconflicted experts to staff the agency's advisory committees, and if it even matters to begin with. Now, the public interest group Union of Concerned Scientists (UCS), has ...
  • Indian Task Force Recommends Adoption of Authentication System for Pharmaceuticals

    Taking a page out of the anti-counterfeiters' playbook, a high-level Indian task force has recommended the adoption of verification technology and mobile text messaging authentication for medicines produced and sold in India, reports BioSpectrum Asia . The technology is already in use in some African countries such as Kenya and Ghana , but the adoption scale recommended by the Union Health Ministry's task force on pharmaceutical manufacturing would dwarf those in sca...
  • Group: Industry Lobbying Tarnishing FDA Integrity

    The science advocacy group Union of Concerned Scientists (USC) is lambasting what it claims is excessive industry pressure on the US Food and Drug Administration (FDA), and claims the pharmaceutical, medical device and biotechnology sectors spent a combined $700 million between 2009 and 2011 to lobby legislative and executive officials. "Pharmaceuticals companies and related trade groups spent more than $487 million on lobbying over this three-year period, while biotechn...
  • Poll: Public In Favor of Increased Medical Device Regulation

    A poll commissioned by industry watchdog group Consumer Reports indicates the vast majority of consumers are in favor of a risk-averse regulatory framework for medical devices , giving ammunition to the group at a time when it is seeking to influence the debate over the reauthorization of the Medical Device User Fee Act . Consumers Union has taken the position that medical devices-particularly those cleared through the US Food and Drug Administration's (FDA) 510(k) pat...