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  • Regulatory NewsRegulatory News

    US and EU Fully Implement Mutual Agreement on GMP Inspections

    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on Friday said they have now fully implemented a plan that will allow member state regulators and FDA to mutually rely on each other’s good manufacturing practice (GMP) inspections of drug facilities. In addition to helping reduce redundancies in manufacturing inspections, the implementation of the Mutual Recognition Agreement (MRA) means that beginning Friday, pharmaceutical companies can sto...
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    EU Regulatory Roundup: Trade Group Warns Preparing UK for October No-Deal Brexit is ‘Impossible’

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Trade Group Warns Preparing UK for October No-Deal Brexit is ‘Impossible’   A biopharma trade group has warned it will be “impossible” to prepare the UK medicine supply chain to withstand the impact of a no-deal Brexit by October. The warning comes as the leading candidate to take over as Prime Minister committed to take the UK out of the EU on 31 October, “do or di...
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    EMA Begins Review of Handling Errors Linked to Leuprorelin

    At the request of Germany’s BfArM, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) initiated a review of depot formulations of leuprorelin medicines because of reports of handling errors during preparation and administration that can cause some to receive insufficient amounts. EMA explains how depot formulations of leuprorelin medicines, which are better known by different brand names like Eligard, Lupron and Procren, release the...
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    EMA Begins Search for Next Executive Director

    As Guido Rasi wraps up his second five-year term as the executive director of the European Medicines Agency (EMA) on 15 November 2020, the search for a new head began officially on Tuesday. Based on the selection and eligibility criteria for the next executive director, according to a vacancy notice published in the Official Journal of the European Union, finding the right candidate will be a difficult process. For instance, prospective candidates will have to mana...
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    EMA Officials Debate Going Beyond Safe and Effective Determinations for New Drugs

    In the US and Europe, drug regulators approve new drugs based on whether the benefits of the new product outweigh the risks. But neither of the regulators consider if such new drugs are superior to drugs currently marketed. Now, three senior officials at the European Medicines Agency (EMA) explain how an added therapeutic benefit criterion or head-to-head comparisons could help to drive more innovative therapies. “The aim of these proposals is to contain the rising c...
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    EMA Fees See 1.7% Increase

    From Monday, all general fees payable to the European Medicines Agency (EMA) will be subject to a 1.7% increase compared to those received by 31 March, as part of alignment with the EU’s 2018 inflation rate. The 1.7% increase applies to applicants’ and marketing authorization holders’ general fees payable to EMA. It brings the previous basic fee of €286,900 ($321,774) up to €291,800 ($327,269) on a new application for which the presentation of a full dossier is needed, ...
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    EMA Tells Pharma Companies to Continue to Prep for UK’s Withdrawal

    With an extension in place that will push the UK's withdrawal from the EU back to either April or May, the European Medicines Agency (EMA) told pharmaceutical companies on Monday to continue their preparations for Brexit. Under the European Council decision from last Friday, if the withdrawal agreement between the UK and the EU is approved by the UK House of Commons by 29 March 2019, the extension will be until 22 May 2019. But if the withdrawal agreement is not approve...
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    EMA on Brexit: Risk for Drug Shortages Decreases

    As the UK and EU agreed to extend the Brexit deadline, the European Medicines Agency’s (EMA) Management Board said following its first meeting in Amsterdam that the prospect for centrally authorized products to be at risk of shortage “continues to decrease.”   The board said the risk has gone down because more companies have taken the necessary steps to ensure that their medicines can remain on the market. EMA last September said the number of centrally authorized me...
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    EMA Opens for Consult ICH M10 Guideline on Bioanalytical Method Validation

    The European Medicines Agency (EMA) on Thursday released for public consultation the International Council of Harmonisation’s (ICH) M10 guideline, which aims to help sponsors improve the quality and consistency of bioanalytical data in support of the development and approval of both chemical and biological drugs. The 57-page guidance, which has been in the works since 2016, provides recommendations for the validation of bioanalytical assays for chemical and biological d...
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    EMA Launches Operations in Amsterdam

    The European Medicines Agency (EMA) on Monday kicked off operations at its temporary premises at the Spark building in Amsterdam Sloterdijk after moving out of its Canary Wharf office in London on 1 March.   EMA says it is also working with Dutch authorities to finish readying its temporary premises ahead of 30 March, when the agency’s seat officially switches from London to Amsterdam.   “By Monday 18 March, when EMA will be settled in the Spark building, close to ...
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    EMA Closes London Office, Preps for New Time Zone

    After 24 years in London, the European Medicines Agency (EMA) on Friday has officially departed and is on its way to Amsterdam following a Brexit relocation vote in November 2017. EMA's permanent Amsterdam headquarters, a tailor-made building in the Zuidas business district, are planned for completion next November. On a temporary basis, the Dutch government has granted EMA the Spark building in the Sloterdijk area of Amsterdam until the permanent building is completed....
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    EMA Opens Consultation on Guideline for Advanced Therapies in Clinical Trials

    The European Medicines Agency (EMA) on Thursday opened for consultation a new guideline on the structure and data requirements for a clinical trial application for exploratory and confirmatory trials with advanced therapy investigational medicinal products (ATIMPs). The 53-page guideline addresses development, manufacturing and quality control, featuring sections on quality documentation (including parts on the active substance and the investigational medicinal product)...