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 ...

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...

Researchers writing in the research publication Journal of Pediatrics (JP) are calling for the increased inclusion of neonates in pediatric drug trials, arguing that the sub-group is highly underrepresented, potentially to the detriment of newborn children. The article , scheduled to be published this week, takes note of an oft-discussed problem: Pharmaceutical products are rarely studied in children to the same extent as adults, resulting in many of those products be...

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...

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 ...

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...

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...

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 ...

The European Medicines Agency (EMA) released three standard operating procedures (SOPs) for the Eudravigilance Medicinal Product Dictionary (EVMPD) on 30 January. Eudravigilance "is a data processing network and management system for reporting and evaluating suspected adverse reactions during the development and following the marketing authorisation of medicinal products in the European Economic Area (EEA)," according to the Eudravigilance website . The Eudravigilance ...

The European Medicines Agency (EMA) released a new question and answer document on 25 January for applicants planning to use the Centralised Procedure to advance generic and hybrid product applications. The guidance "provides an overview of the EMA position on issues, which are typically addressed during the course of Pre-Submission Meetings." EMA stresses the "importance of Pre-Submission Meetings with applicants", which should take place 6 months before the planned d...