• US, EU Regulators Extend QbD Pilot, Pledge Release of Further Quality Guidelines

    • 06 March 2014
    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have extended for another two years a pilot program that allows both agencies to simultaneously review quality-by-design (QbD) applications. Background The pilot program was first launched in March 2011 as a means by which both agencies could communicate review findings with respect to QbD elements of applications chosen for review. QbD refers to purposeful pharmaceutical development in which...
  • FDA Program to Loosen Import Restrictions for 13 Major Pharmaceutical Manufacturers

    Thirteen of the US' most prominent pharmaceutical manufacturers will be allowed to import their products into the US with less regulatory scrutiny under a pilot program set to begin this year, the US Food and Drug Administration (FDA) has announced. Background FDA first announced the pilot program, known as the Secure Supply Chain Pilot Program (SSCPP) in January 2009 with that stated intent of better securing finished pharmaceutical products and their raw active ingred...
  • Program Intended to Clear Path for Easier Medical Device Studies Kept Alive

    The US Food and Drug Administration (FDA) has announced the extension of a pilot program first announced in November 2011 that aims to facilitate early feasibility studies for experimental medical devices. Background The 2011 announcement by FDA explained that the agency "intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the investigational device exemptions (IDE) requirements." IDE applications ar...
  • MHRA Advocates Use of Online Submissions Platform by Applicants

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is "strongly" encouraging all applicants to participate in its pilot participation in the Central European Submissions Platform (CESP), an online-based secure submissions system. Currently, applicants are permitted to submit applications to MHRA using data contained on CDs or DVDs, depending on the size of the submission. However, this submission style necessitates manual handing of media, storage spac...
  • France's ANSM Announces Launch of Nine Regulatory Pilot Projects

    • 29 October 2012
    French regulators have announced the results of an open call for regulatory projects aimed at improving the public health by improving how information is reported to patients and caregivers, how regulators investigate products with possible health risks to the public, and allowing patients to self-report adverse events to regulators. The projects are among the first for the recently-formed National Security Agency of Medicines and Health Products (ANSM), which was form...
  • Health Canada Expands Use of Foreign Data

    Health Canada announced on 28 September the expansion of its pilot project on the use of drug review assessment information from foreign regulatory agencies, such as the European Medicines Agency, in its own marketing authorization review process.   The Use of Foreign Reviews pilot project was first initiated in October 2011 to test whether access to such data would assist Health Canada in meeting its regulatory assessment "targets" by speeding up the applica...
  • EU Regulators Expand Electronic Submission Program, Recommend Wider Use

    After a four-month pilot period, EU regulators are proposing to make permanent a program that allows applicants and sponsors of marketing authorization applications to submit their entire dossiers electronically. The European Medicines Agency's (EMA) 27 July statement on continuing the electronic application form (eAF) pilot program says the testing phase was "successful," and use of the program will allow sponsors and applicants to better control the quality and consist...
  • Revised FDA Enforcement Report Stresses Clarity, Data Accessibility

    Regular readers of the US Food and Drug Administration's (FDA) weekly enforcement reports-the vehicle through which the agency publishes recalls initiated by or reported to FDA-will see a big change to the reports starting today. On 21 June, FDA announced it has completed a planned revision of the reports to make information easier to understand, quicker to read and more accessible to technology. In an announcement in early June 2012 , FDA said it planned to roll out a ...
  • FDA Wants Supply Chain Security Pilot Program to Continue

    Call it ironic timing. On the same day Congress announced the removal of a pharmaceutical supply chain protection system from the pending Food and Drug Administration Amendments Act (FDAAA) , the US Food and Drug Administration (FDA) announced it is looking to continue a supply chain protection pilot program. The initiative, called the Secure Supply Chain Pilot Program, was launched in January 2009 with the intent of better securing finished pharmaceutical products ...
  • Lawmakers: Reform 'Indefensible' Blood Donation Policy

    A group of 62 US lawmakers sent US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius a letter on 11 June expressing their collective support for a draft policy announced in March 2012 that would examine the feasibility of relaxing rules currently prohibiting gay men from donating blood or plasma. In DHHS's Request for Information on Design of a Pilot Operational Study to Assess Alternative Blood Donor Deferral Criteria for Men Who have Had Sex ...
  • FDA Plans Major Overhaul of Recall Reporting

    The US Food and Drug Administration's (FDA) weekly enforcement reports, which detail product recalls and corrections taken during the week, are about to get a major overhaul according to an agency announcement. The agency last week reported in a little-noticed item within its enforcement report that it would be making changes to the way it updates its enforcement reports for pharmaceutical product recalls. The agency wrote at the time it intends to "modify the drug pro...
  • FDA Looking to Speed up Public Notification of Recalls

    An item tucked within the US Food and Drug Administration's (FDA) weekly enforcement report indicates the agency is looking to speed up the way it notifies the general public regarding pharmaceutical recalls. FDA current publishes its recalls of all products in an extensive and sprawling document known as its Enforcement Report, which it publishes every Wednesday. The Enforcement Report is organized by product type and by the severity of the recall, but it is difficult t...