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  • Regulatory NewsRegulatory News

    Updated: Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars

    The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars for Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab). Amgevita is authorized for all of the same indications as Humira, while Solymbic, which won approval through a duplicate marketing authorization application (MAA), is authorized for all indications except polyarticular juvenile idiopathic arthritis. Duplicate MAAs: Public Health or Co-Mar...
  • EMA to Phase out Support for Non-Electronic Submissions in 2014

    The European Medicines Agency (EMA) has announced that its eSubmission Gateway will become mandatory for all electronic common technical document (eCTD) submissions made to the agency through the centralised procedure starting in May 2014. Background The eCTD is a standardized document format used around the world for the submission of pharmaceutical products, and uses a module approach to organize data in a way that makes submissions acceptable to a wide range of reg...
  • 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 Launches Full eCTD Submission Platform for Human Medicines Applications

    The European Medicines Agency (EMA) has launched its eSubmission Gateway and a new eSubmission web client for the submission of applications for human medicines, it announced on 15 January 2013. The eSubmission platform allows for the submission of the electronic common technical document, a harmonized, tiered submission format that allows for easier submissions across multiple geographic regions. The release II update to the gateway "allows applicants to submit doc...
  • 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...
  • Brazil: New criteria for priority drug review

    A public consultation on new criteria for prioritizing the review of drug approval applications is planned by Brazil's regulatory agency, ANVISA.  The agency intends to propose a point system for determining which drugs should be "placed in front of the queue for review."  According to the agency, an example of a marketing approval application that would get priority is for a generic version of a brand name drug that has no market competition.  Read...
  • MHRA Announces 'Procedural Changes' for Submission of Labels, Patient Leaflets

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced last week (29 March) it would be making "procedural changes" to the process by which sponsors of marketing authorization applications (MAAs) submit full-color mock-ups of labels and patient leaflets. In its new guidance, Labels & Patient Leaflets in the Initial & Final Submission Documents for New MA and Type 1B or Type II Variation Applications , MHRA notes several changes, including:...
  • EMA, HMA Release Joint Guidance Document on Commercially Confidential Information in MAAs

    The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced 27 March they have adopted a joint guidance document that will provide a "consistent Europe-wide approach to the identification of commercially confidential information and personal data in a marketing authorization application." "In [the] future, regulatory authorities in the European Economic Area (EEA) will apply the same principles to identify which parts of an application dossier...
  • 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...
  • UPDATED: EMA, AFSSAPS Call for Stricter EU Regulations on Medical Devices

    European Medicines Agency (EMA) Executive Director Guido Rasi and French Health Minister Xavier Bertrand called on the EU to require medical device makers to go through a more rigorous approvals process that would require the sort of marketing authorization currently given to pharmaceutical products, according to Reuters articles . "I see an urgent need to regulate devices at the same level of science and attention as with drugs," said Rasi, the new head of EMA. Curren...