• Feature ArticlesFeature Articles

    Navigating the maze of electronic submissions at EMA

    The European Medicines Agency (EMA) facilitates a range of different submissions and application processes using several submission systems for electronic procedures, which have clear advantages over paper-based submissions. At present, first-time applicants cannot proceed with a regulatory submission unless they have set up several accounts and assigned roles and registered their companies and their assets. However, there is no “one-stop-shop” place on the EMA website for...
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    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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    European Regulatory Roundup: MHRA Rolls Out Online Portal to Streamline Medical Device Regulatory Services (18 January 2018)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Calls for HES Solutions to be Pulled From Market Over Kidney Injuries Europe looks set to suspend  the marketing authorizations for hydroxyethyl-starch (HES) solutions for infusion. The Pharmacovigilance Risk Assessment Committee (PRAC) recommended the suspension after a review found restrictions it imposed in 2013 had failed to stop the use of the drugs in patien...
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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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    FDA Launches New Online Portal for Requesting Pre-ANDA Meetings

    Thanks to the new Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) this week launched a new online platform to allow industry to request pre-ANDA (abbreviated new drug application) meetings for complex generic drugs.  The CDER Direct NextGen Collaboration Portal allows potential ANDA applicants to initiate requests by uploading a meeting request package and to submit supporting documents, such as meeting presentation materials, re...
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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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    Application of EU Clinical Trial Regulation Delayed to 2019

    The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed. "Due to these delays, the EU  Clinical Trial Regulation  will now come into application in 2019 instead of October 2018, as previously scheduled," EMA said Friday. The agency says it will provide an update at the next meeting of the Management Board in October 2017, followi...
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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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    EMA Board Signs Off on New Medicines Web Portal

    The European Medicines Agency’s (EMA) management board on Monday announced that it’s given the go-ahead for a new European medicines web portal, which will look to provide wider access to free, reliable and unbiased information on all medicines authorized in the EU. The portal, which will replace EMA’s online interface EudraPharm , will offer updates on everything from clinical trial information to adverse drug events. Background 2010 pharmacovigilance legislation, ...