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  • Article

    EMA Issues Draft Guidelines On Post-Market Studies

    PAES may be imposed by regulators or carried out voluntarily by companies, and the draft scientific guideline applies to both scenarios.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EMA Issues Recommendations To Minimize Risk Of Rare Brain Infection PML With Tecfidera

    On October 23, 2015, the CHMP gave new advice for doctors and patients in order to minimize the risk of progressive multifocal leukoencephalopathy in patients treated with the multiple sclerosis medicine Tecfidera.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
Jones Day
  • Article

    EMA Provides Update On The Implementation Of Transparency Policy

    The European Medicines Agency ("EMA") has published a video and presentations from its June 24, 2015, webinar, which provide an update on the implementation of its Transparency Policy.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EMA Publishes Guideline On Processing Of Renewals In The Centralized Procedure

    On July 28, 2015, EMA published a draft guideline on the processing of renewals in the centralized procedure.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EMA Recommends 10 New Medicines Marketing Authorization

    During its July 2015 meeting, the European Medicines Agency ("EMA") Committee for Medicinal Products for Human Use ("CHMP") recommended for marketing authorization 10 new medicines.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EU Commission Issues Regulation On Vitamin D Claims

    On November 17, 2014, Commission Regulation (EU) No 1228/2014 of 17 November 2014 authorising and refusing to authorise certain health claims made on foods and referring to the reduction of disease risk was issued.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EU Commission Issues Regulation Rejecting Certain Glucose Claims

    On January 6, 2015, certain health claims relating to glucose were rejected by Commission Regulation (EU) 2015/8 of 6 January 2015...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EU Issues New Regulations On Maximum Levels Of Lead And Inorganic Arsenic

    On June 25, 2015, EC published two regulations, Regulation 2015/1005 and Regulation 2015/1006, which amend Regulation Annex No. 1881/2006 by setting maximum levels of lead and inorganic arsenic in certain foodstuffs, respectively.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EU Publishes Summaries Of Marketing Authorizations

    On May 5, 2015, the EU published summaries of marketing authorizations granted during February and March 2015.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    Europe Bans Chinese API Maker Following An Inspection In Late January

    In 2012, the company faced similar issues with European regulators after refusing to allow inspectors into its facilities.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Agency's 64th Management Board Meeting

    EFSA invites the public to observe the proceedings of the 64th Management Board meeting.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Agency Launches Central Repository To Facilitate Assessment Of Medicines Safety Reports

    On January 26, 2015, the European Medicines Agency launched an electronic repository for periodic safety update reports ("PSURs") and their assessment reports.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Commission Amends Food Supplements Directive

    On March 12, 2015, the European Commission issued Commission Regulation (EU) 2015/414 of 12 March 2015, amending Directive 2002/46/EC of the European Parliament and of the Council...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Commission Authorizes A Health Claim On Cocoa Flavanols

    On March 31, 2015, the European Commission issued Commission Regulation (EU) 2015/539 authorizing the following health claim...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Commission Authorizes Oil From Micro-Algae Schizochytrium As A Novel Food Ingredient

    On March 31, 2015, the European Commission issued Commission Regulation (EU) 2015/545 authorizing the placing on the market of oil from the micro-algae Schizochytrium sp...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Commission, EMA, And WHO Step Up Cooperation

    The aim of the new working arrangement is to strengthen communication between the respective organizations and make it easier to take action to protect public health.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Commission Implements A Coordinated Pesticides Control Program For 2018, 2019, And 2020

    On April 7, 2017, the Commission Implementing Regulation 2017/660 ("Regulation") was published in the Official Journal of the EU.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Commission Issues New Guidelines On The Formalized Risk Assessment For Ascertaining The Appropriate Good Manufacturing Practice For Excipients

    On March 19, 2015, the European Commission issued new guidelines on risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Commission Publishes New Version Of Annex 15

    On March 30, 2015, the European Commission published the new version of Annex 15 "Qualification and Validation" of EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Commission Recommends Monitoring Mineral Residues In Foods

    The monitoring data should be supplied to EFSA.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Showing 21–40 of 14474 results

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