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  • Regulatory NewsRegulatory News

    EMA to Review InductOs After US Manufacturer Cited for Contamination Issues

    The European Medicines Agency (EMA) has announced it is conducting a review of Medtronic's implantable bone-development product, InductOs, after Spanish and Dutch inspectors discovered contamination issues at a US manufacturing site which makes one of its components. Background InductOs was authorized via the centralized procedure in 2002 and is marketed by Medtronic BioPharma B.V., headquartered in the Netherlands. InductOs is used to promote bone development in pati...
  • Regulatory NewsRegulatory News

    EMA to Share Information About Generic Drugs With Other Regulators

    The European Medicines Agency (EMA) has announced it is ready to begin sharing its assessments of generic drugs as part of an ongoing pilot with participating regulatory authorities. The goal of the pilot program, known as the International Generic Drug Regulators Pilot (IGDRP), is to bolster collaboration with regulators around the world and address the challenge of assessing generic drug applications. Background In October 2011, regulatory authorities from Australia...
  • EMA Revamping How it Handles Submission of Applications and Requests for Advice

    The European Medicines Agency (EMA) has announced that it will soon change the way it handles changes to approved marketing authorizations (MAs) and other regular reports. Background As in the US, pharmaceutical companies are required to notify EMA of all changes made to their medications and manufacturing processes, as well as keep regulators informed about the safety of their products and any transfers of ownership. Those changes fall into several categories , inclu...
  • 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...
  • EMA to Conduct Safety Review of EU and Nationally Approved Drugs

    The European Medicines Agency (EMA) has announced a milestone safety review of drugs approved through both the centralized EU procedure and the national procedure, based on the active substance that a drug contains. The review is slated to begin on 1 April 2013. Until now, the agency's review of the safety of marketed drugs has been limited to medicines authorized through the centralized procedure.  EMA's expanded authority to undertake such a review was granted ...
  • Centralized Procedure to see Simplified Submission Process, Says EMA

    The European Medicines Agency (EMA) has announced that it has simplified the process by which marketing authorization applications (MAAs) are submitted to the agency, reducing the number of applications that marketing authorization holders (MAHs) need to submit during the centralized procedure. The changes comes just as EU regulators are in the midst of implementing the pharmacovigilance legislation, an EU-wide set of requirements intended to make it easier to track and ...
  • EMA Updates Guidance on Centralised Procedure

    The European Medicines Agency's (EMA) has released a revised version of its procedural advice for sponsors of medicinal products using the centralised procedure, part of an ongoing series of revisions to one of its key regulatory documents . The centralised procedure , established in EC No. 726/2004, is intended to allow application sponsors to obtain a single marketing authorization from EMA that is accepted throughout the EU. With the passage of additional legislat...
  • Rules for Blood Testing, Storage Changed

    • 29 August 2012
    The U.S. Food and Drug Administration (FDA) is changing the rules for human blood testing and storage, according to a report by in-Pharma Technologist . A new procedure issued by FDA allows for exceptions or alternatives with regard to blood, blood components or blood products. Requests for such exceptions or alternatives should be made in writing. Manufacturers can store thawed plasma at 1 to 6 degrees Celsius for up to 24 hours, according to the news report. Donors w...
  • 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...
  • EMA Tightens Conflict-of-Interest Policies

    The European Medicines Agency (EMA) announced it will, effective immediately, be tightening its conflict-on-interest policies for scientific experts and members of advisory committees. The policy was announced 3 April after being endorsed by EMA's Management Board on 22 March 2012. "The updated policy gives clearer guidance on the involvement of experts in academic trials and publicly funded research," explained EMA in a statement. "It aligns restrictions for the differ...
  • EPA Case Could Imperil FDA Warning Letters

    A unanimous decision last week by the Supreme Court of the United States (SCOTUS) against the US Environmental Protection Agency (EPA) could place warnings letters sent by the US Food and Drug Administration (FDA) into a quagmire of litigation, report various sources. In Sackett v. EPA , SCOTUS ruled the Administrative Procedure Act-the act governing how FDA and other federal agencies create regulations and make decisions-did not preclude the litigants from immediately ...