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08 September 2011

A Supreme Court judge set to hear a case involving a challenge by Novartis against Section 3d, a controversial provision in India's patent law, has recused himself ? a move that is now expected to require a new judge to hear the case at a later date ...

12 October 2010

The Tanzanian Food and Drugs Authority has issued two complementary draft guidelines to further the implementation of its new medtech regulatory framework 1 ,2 . The first draft document describes the agency's processes and procedures for issuing ...

28 September 2009

The World Health Organization has endorsed the Pan African Clinical Trials Registry as the primary trials registry in Africa 1 ,2 . The PACTR, which was officially launched at the African Vaccine Regulatory Forum in Nigeria on 25 September 3 , is ...

08 September 2011

A Supreme Court judge set to hear a case involving a challenge by Novartis against Section 3d, a controversial provision in India's patent law, has recused himself ? a move that is now expected to require a new judge to hear the case at a later date ...

28 July 2011

Australia's Therapeutic Goods Administration has published a consolidated guidance under its new biologicals framework, which came into force on 31 May and has a three-year transition period 1 ,2 . The consolidated guidance, called the Australian ...

08 September 2011

A new guidance on developing human cells for clinical applications is available 1 . The guidance was issued by the British Standards Institution , which says the document was written with an EU/US audience in mind and anticipates that it will be ...

02 August 2011

The Danish Medicines Agency has issued a list clarifying which clinical trial amendments will require approval by the DMA and which modifications can merely be notified to the agency 1 ,2 . The list has been issued in response to questions on the ...

22 June 2011

The Global Harmonization Task Force has published a consolidated list of the definitions commonly used in its final guidance documents 1 . The list consolidates the various definitions published in guidance documents written by different study ...

21 June 2011

In a drive to expand its global reach, the International Conference on Harmonisation has for the first time nominated non-ICH regulators to serve in its quality, safety and efficacy expert working groups; specifically, technical experts from China, ...

23 February 2011

Brazil's R&D-based industry association, Interfarma, has welcomed a controversial legal decision to restrict the powers of medicines regulator Anvisa in the granting of patents. Nevertheless, it says the move does not go far enough. Meanwhile, civil ...

10 September 2010

The promise of a system of device and in vitro diagnostics regulation is still very much alive in South Africa, even if the timelines remain sketchy. South Africa has a growing medtech market ? 95% supplied by imports ? but it has never had a ...

08 September 2011

A new guidance on developing human cells for clinical applications is available 1 . The guidance was issued by the British Standards Institution , which says the document was written with an EU/US audience in mind and anticipates that it will be ...

08 September 2011

The US Food and Drug Administration has expressed concern over the protracted negotiations it is having with the medtech industry over reauthorising its medical device user fee programme, minutes from a 2 August meeting between the FDA and industry ...

 
27 April 2011
Ashley Yeo
With the US in mid-regulatory review, stakeholders are keenly pushing for a safer and faster system, but there are different views on how these goals should be achieved. That was shown at a hearing of the US Senate's Special Committee on Aging 1 . ...
 
23 July 2010
Amanda Maxwell
TÜV Product Service , one the main notified bodies for medical devices in the European Union, is in no doubt that the basic EU medtech regulatory structure is sound. But as work is being carried out to improve standards among notified bodies, the ...
 
28 July 2011
Michael Pears and Mike Snodin consider the opinion of an Advocate General of the Court of Justice of the EU on granting supplementary protection certificates for combination medicines. In a non-binding opinion issued on 13 July, Advocate General ...
21 June 2011
Ellen Leinfuss discusses six key triggers that may attract an inspector's aggressive scrutiny of cGMP compliance and product quality. The US Department of Justice , the Health and Human Services' Office of Inspector General and the Food and Drug ...
21 June 2011
Maria Cianciotto outlines how companies can ensure they are prepared for inspections at all times. A cost-centre, a roadblock, a speed bump on the road to success. As regulatory professionals, we've all heard these types of descriptions when talking ...
 
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
 
RAJ Devices News Roundup, 11 December 2009
28 July 2011
 
ACRP appoints chair of GCC The US-based Association of Clinical Research Professionals has confirmed the appointment of Dr Satish Chandra as chairman of the association's Gulf Cooperative Council (GCC) Chapter. Dr Chandra is a specialist and head of clinical research at Tawam ...
Critical Path Institute seeks new leader as founder retires The founder of the Arizona-based Critical Path Institute (C-Path), Raymond Woosley , has announced that he is to retire on 31January 2012, leaving its board of directors in search of a new chief executive 1 . Woosley founded C-Path six years ago as ...
 
   
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