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  • Regulatory NewsRegulatory News

    EMA Expands Online Portal for Parallel Distribution Submissions

    The European Medicines Agency (EMA) on Monday announced that going forward, parallel distributors will be required to use its recently launched secure online portal, known as Iris, to manage and submit parallel distribution notifications.   Background   Parallel distribution, also known as re-exportation, is a process by which companies in the EU distribute centrally authorized medicines between member states, independent of their marketing authorization holder (...
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    Asia Regulatory Roundup: India Introduces Tougher Regulations on Homeopathic Medicines (20 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australian Generic Medicine Work-Sharing Trial Misses Completion Target A work-sharing group involving Australian regulators has reported the results of its first collaborative assessment of a generic medicine. The review of the filing took about nine months, four months longer than the collaborators had targeted at the start of the project. Officials from Australia’...
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    Asia Regulatory Roundup: China Strengthens Supervision of Online Drug, Device Sales (7 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Strengthens Supervision of Online Drug and Medical Device Sales The China Food and Drug Administration (CFDA) has moved to strengthen oversight of online sales of drugs and medical devices. CFDA outlined its plans in a notice instructing its regional outposts to step up their monitoring of the internet and make it easier for the public to alert them of illegal a...
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    Asia Regulatory Roundup: Australia Proposes to Align Device Regulations With EU (1 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Seeks Feedback on Proposed Alignment of Australian and European Medical Device Rules The Therapeutic Goods Administration (TGA) of Australia is proposing to align parts of its medical device regulatory requirements with those in place in Europe. TGA is gathering feedback on plans to reclassify surgical mesh and place new requirements on manufacturers of implants wi...
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    European Regulatory Roundup: UK Starts Risk-Based Inspections of Online Pharmacies (9 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Starts Risk-Based Inspections of Online Pharmacies After Finding bad Actors The United Kingdom has initiated a risk-based inspection program targeting online pharmacies and healthcare service providers. Officials at the Care Quality Commission (CQC) began the operation after urgent inspections of two digital providers of primary care and a review of 43 other services rais...
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    Asia Regulatory Roundup: India Asks China to Expedite GMP Inspection to Resolve a Drug Shortage (14 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Asks China to Expedite GMP Inspections, Resolving Essential Medicine Shortage India has resolved the shortage of a rare disease drug after asking China to expedite the inspection of a manufacturer of active pharmaceutical ingredients (APIs). The Drug Controller General of India (DCGI) made the cross-border intervention to accelerate the resumption of API supply ...
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    RAPS' Regulatory Exchange Wins 'Most Successful Community' Award

    RAPS’ members-only online community, Regulatory Exchange or “RegEx” as it is often called, was recently named one of three “Most Successful Community” award winners of 2016 by Higher Logic. RegEx is built on the Higher Logic platform. Award winners were honored during the company’s recent Super Forum event in Arlington, VA. The annual awards highlight and celebrate the company’s clients that have achieved significant results through the implementation and us...
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    Association Calls on FDA to Regulate Online Vision Exam as Medical Device

    The American Optometric Association (AOA) has submitted a complaint to the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) over an online eye exam that may not accurately generate prescriptions for eyeglasses or contact lenses. The complaint is directed at Opternative , which is marketing its online eye exam directly to consumers and claiming that it can provide a prescription for eyeglasses or contact lenses “as accurate as an i...
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    Counterfeit Versions of Gilead’s Blockbuster Hepatitis C Drug Found in Israel

    Counterfeits of Gilead’s mega-blockbuster hepatitis C treatment Harvoni, which is generating billions per quarter in sales for the company, are emerging in Israel. Switzerland’s drug regulator Swissmedic said over the weekend that the plastic bottles of the counterfeits, which originated in India, were imported via a Swiss trading company and “contain white instead of genuine yellow film-coated tablets,” the regulator said. Swissmedic is working with other EU authoritie...
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    New FDA Guidance for First Responders as Track-and-Trace Requirements Take Effect

    Beginning Tuesday, the delayed implementation of product tracing requirements for pharmacies will take effect, and the US Food and Drug Administration (FDA) on Monday issued final guidance saying it will not take action against first responders who fail to obtain tracing information. Background On 27 November 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law, putting forth new definitions and requirements related to pharmaceutical product tracking and...
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    MHRA Takes Action on LinkedIn Pharma Marketing

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Friday said it has reprimanded the dermatology company Galderma after receiving an anonymous complaint about promotional material for a prescription drug shared on the social networking site LinkedIn. MHRA said it upheld the complaint as the UK, unlike the US, does not allow prescription-only medicines to be promoted to the public though it does allow advertisements for over-the-counter medicines, accor...
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    Interoperable Medical Devices: FDA Offers Design, Labeling Considerations

    With an eye on helping medical device manufacturers ensure their products can safely and effectively exchange data, the US Food and Drug Administration (FDA) on Monday released new draft guidance on how to design such interoperable devices, as well as recommendations for labeling. The advance of interconnected devices could be a boon for patient care, particularly in cases where device-specific information, such as unique device identifiers (UDIs), and patient-specific d...