RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    MHRA Investigates GMP Deficiency Trends From 2016

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Tuesday released a new report on the trends seen from inspecting pharmaceutical manufacturing plants and evaluating their good manufacturing practices (GMPs) in 2016. Compared to 2015, MHRA conducted 21 more total GMP inspections in 2016, and three more foreign inspections. But like in 2015, the most cited deficiency for 2016 was related to companies’ quality systems. Sterility assurance, producti...
  • Regulatory NewsRegulatory News

    FDA Review Times Steadily Decreasing, Report Finds

    Despite wide variations across therapeutic areas, FDA review times for new drugs have steadily declined since 2009, according to a report released Tuesday by the California Life Sciences Association and Boston Consulting Group. Back in 2009, FDA was averaging 21 months for reviewing new molecular and biologic entities, but five years later, that average has been cut by more than half to nine months in 2014. In addition, the number of applicants waiting more than two year...
  • Regulatory NewsRegulatory News

    The Top 15 Pharmaceutical Deficiencies Cited by FDA in 2014

    The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of pharmaceutical facilities, indicating the most common issues faced by pharmaceutical companies. Total 483s Issued Declines for First Time in Six Years In its most recent report, FY 2014 Inspectional Observation Summaries , FDA said it issued 645 Form 483s—forms indicating areas of noncompliance at a facility—to pharmaceutical companies in fiscal year 2014. ...
  • Regulatory NewsRegulatory News

    The Top 15 Medical Device Deficiencies Cited by FDA in 2014

    The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of medical device facilities, indicating the most common issues faced by medical device companies. Total 483s Issued Declines for First Time in Six Years In its most recent report, FY 2014 Inspectional Observation Summaries , FDA said it issued 972 Form 483s—forms indicating areas of noncompliance at a facility—to medical device companies in fiscal year 2014. ...
  • Canada's 2011 Adverse Event Data Shows Increasing Number of Reports

    Canadian health regulators have released a detailed breakdown of all adverse event reports submitted to Health Canada in 2011, providing a number of interesting insights and trends. Health Canada said it had received 41,923 domestic adverse event reports (AERs), of which 78% were classified as "serious" adverse events. The overwhelming majority of these cases concerned pharmaceutical products (27,602) and biotechnology products (12,419). The remaining products-blood prod...
  • EMA Looks Back on a Tough Year as it Forges Ahead

    Kent Woods wants stakeholders to know he understands: 2011 was a tough year. As Chair of the European Medicines Agency's (EMA) Management Board and head of the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Woods has had a front seat to many of Europe's most difficult regulatory problems. The last year saw EMA's long-time Executive Director, Thomas Lönngren, resign in the midst of controversy and a new ED, Guido Rasi, inherit an agency in the midst...
  • Report: 'Dramatic' Increase in Q1 Medical Device Recalls

    A new report tracking medical device recalls during the first quarter of 2012 shows a massive spike in medical device recalls, reversing a fourth quarter (Q4) 2011 trend of reduced recalls. Medical device recalls increased 160% from Q4 2011 through Q1 2012 while the number of recalled units increased 508%, writes Mike Rozembajgier of the recall tracking company ExpertRECALL. The number of recalls was the most since 2010. While the increase was "dramatic," it also...