The growth of drug development and outsourced clinical work is causing regulatory affairs officials at pharma and biotech firms to increase their workload more than ever before, according to a new...
The US Food and Drug Administration has become more conservative in allowing evidence from non-inferiority clinical trials when considering approval of new drugs, the Government Accountability Office...
Top level regulators in Europe have rejected a recommendation that the European Medicines Agency create a dedicated sub-committee to deal with the current overload of applications for generic and...
The US Food and Drug Administration is pressing on with efforts to gather input on how its next prescription drug user fee programme should be framed and consider how performance failures associated...
The US Department of Health and Human Services has called for the Food and Drug Administration to improve its oversight of foreign clinical trial data after finding that sponsors rely “heavily” on...
New European Union rules on the use of animals in medical experiments – including more flexible authorisation procedures and promoting alternatives to animal testing – are expected to be approved in...
A US congressional committee has begun an investigation into the circumstances surrounding the most recent voluntary recall by McNeil Consumer Healthcare of more than 40 widely used over-the-counter...
A proposal by Health Canada to significantly increase its user fee rates for regulatory activities covering the drug and medical device sectors has been tabled in both houses of parliament by the...
Newly proposed legislation in Russia on the regulation of medicinal products and data exclusivity rights has drawn the attention of the global research-based pharmaceutical industry, which is urging...
The Spanish Medicines and Healthcare Products Agency ( AEMPS ) has taken additional steps under its initiative to increase the transparency of and accessibility to information for healthcare...
The European Directorate for the Quality of Medicines & Healthcare has carried out an inspection campaign at sites in China manufacturing active substances for pharmaceutical use 1 . The campaign was...
The European Medicines Agency has begun drawing up guidance for manufacturers developing, or planning to develop, biosimilar versions of originator monoclonal antibodies. The aim is to ensure a more...
Swissmedic has issued a new guideline on the authorisation of generics, effective 1 October 1 . In assessing generic applications, Swissmedic will in future take into account international...
The UK’s Medicines and Healthcare products Regulatory Agency has issued a proposal to amend the way it handles application fees for marketing authorisations and variations 1 . The move is part of a...
China’s State Food and Drug Administration has issued review and inspection standards for the “qualification confirmation” of institutions conducting clinical studies 1 . The aim, the SDFA said, was...
