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  • EU Marketing Authorization Holders Have 40 Days to Make Labeling Changes

    The European Medicines Agency (EMA) is once again warning applicants and holders of marketing authorizations to be mindful of the pending addition of Croatia to the EU, which has a number of regulatory implications for pharmaceutical companies. Holders of marketing authorizations (MAHs) are legally required to have their product information, including labeling, available in the official languages of all EU member states. As of March 2013, there are 27 such states, stretc...
  • European Marketing Application Rates Set to Increase in 2013

    The European Medicines Agency (EMA) has announced that application fees will go up approximately 2.6% in the coming fiscal year, roughly on par with the EU rate of inflation for the previous year. The exact fee, set to go into effect on 1 April 2013, is not known, EMA noted. That's because the final fee adjustment must be approved by both EMA's Management Board and the European Commission (EC), a process set to conclude in March 2013. "The European Commission is current...
  • EMA Phasing Out Follow-Up Measures

    The European Medicines Agency (EMA) is phasing out so-called "follow-up measures" for human drugs requiring post-marketing studies this month, instead replacing them  with three categories of post-marketing commitments: Conditions in Annex II (obligations or specific obligations to fulfil post-authorization measures); Additional pharmacovigilance activities in the risk-management plan; Recommendations for further development. The old "follow-up measures" estab...
  • EMA Releases Updated Final Guideline on Active Substance Master Files

    A new final guideline published on 13 July 2012 by the European medicines Agency (EMA) updated the Active Substance Master File (ASMF) Procedure -its first upgrade since its formation in 2006. The ASMF procedure, formerly known as the European Drug Master File (EDMF) procedure, is used to protect confidential intellectual property information while allowing regulatory agencies to access a more complete picture regarding how an active substance is manufactured. Both EMA a...
  • Electronic Submission Gateway Goes Live for Human Medicines Submissions, Announces EMA

    The European Medicines Agency (EMA) is announcing its eSubmission Gateway-the "electronic submission channel" for submitting electronic common technical documents (eCTDs) to EMA-is now up and running for all applicants for centralized marketing authorizations. The program, announced 23 April, was originally launched as a pilot program in January 2012 meant to gauge the usefulness of the electronic submission process. EMA said in a statement it has seen "an increase in ...
  • EMA Posts Revised Integrated Guidance on Use of Centralized Procedure

    The European Medicines Agency (EMA) has released a revised integrated guidance document containing advice for user of the centralized procedure. EMA's 18 April revision of the Q&A document represents its 21 st revision, and is a comprehensive resource including information from a wide range of regulations and guidances. "This guidance document addresses a number of questions which marketing authorization holders (MAHs) may have on post-authorization procedures," ex...
  • Brazil: New Risk Mitigation Regulation for Devices

    A new regulation ( RDC n o.23 ) published on 9 April 9 2012, requires marketing authorization holders to undertake a series of actions to reduce the risk associated by adverse events related to devices that are marketed in Brazil.  The required actions may involve the effective and timely recall of the product and the need to disseminate public warning messages.  The company must also report to ANVISA the actions it has undertaken, including the assistanc...
  • EMA Application, MAH Fees Set to Rise 3.1% on 1 April

    The European Medicines Agency (EMA) is preparing to raise fees by 3.1% on 1 April 2012 for all applicants and marketing-authorization holders (MAHs), the agency said in a statement. "Every year, the Agency adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year," said EMA in a statement posted on its website. "All applications received at the Agency by 31 March 2012 will be charged at the current fee and reduction rates. App...
  • EMA Releases Guideline on Pharmacovigilance Plan Submissions

    The European Medicines Agency (EMA) released guidance 29 February on how Marketing Authorization Holders (MAH) can submit pharmacovigilance (PhV) systems as part of their Marketing Authorization Application . The plans are used to detect, understand, prevent or otherwise minimize adverse events occurring as the result of medicinal products. "This document provides clarification and further explanation of the requirements for a detailed description of the PhV system (DD...
  • Feature ArticlesFeature Articles

    The French Act N°2011-2012: Boosting Safety or Creating a Storm?

    The scandal surrounding French adjuvant therapy in hypertriglyceridemia and overweight diabetics drug Médiator, and the many deaths apparently linked to the product directly led to enactment of  The French Act N°2011-2012   of 29 December 2011 by the National Assembly. The law, sponsored by France's Ministry of Labor, Employment and Health to restore public confidence and enhance the safety of medicinal and health products, affects all stakeholders ...