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03 July 2015

 
02 July 2015

The Malaysian Medical Device Authority is inviting feedback on two draft guidelines that explain how medtech companies should handle complaints regarding their products and how they should undertake field corrective actions 1 ,2 . Comments on both ...

02 July 2015

Chinese regulators need to learn from international regulatory experience on how to shorten timeframes for drug applicants', according to Wang Tao, deputy director of the China Food and Drug Administration?s Center for Drug Review. In particular, ...

02 July 2015

The China Food and Drug Administration has joined the International Coalition of Medicines Regulatory Authorities and hopes the move will jumpstart its efforts to upgrade overall regulatory capability 1 . Multiregional clinical trials (MRCTs) and ...

02 July 2015

Click on the links to access the documents Country Organization Document Status Australia TGA General dossier requirements Final EU EMA Reflection paper on classification of advanced therapy medicinal products Final Malaysia MDA Complaint ...

03 July 2015

Drug companies that want to offer payers a more attractive price to secure market access for their new innovations should try a whole new approach to R&D. Step away from the randomized control trial (RCT), consult with patients and exploit data ...

02 July 2015

The Malaysian Medical Device Authority is inviting feedback on two draft guidelines that explain how medtech companies should handle complaints regarding their products and how they should undertake field corrective actions 1 ,2 . Comments on both ...

02 July 2015

Chinese regulators need to learn from international regulatory experience on how to shorten timeframes for drug applicants', according to Wang Tao, deputy director of the China Food and Drug Administration?s Center for Drug Review. In particular, ...

02 July 2015

The China Food and Drug Administration has joined the International Coalition of Medicines Regulatory Authorities and hopes the move will jumpstart its efforts to upgrade overall regulatory capability 1 . Multiregional clinical trials (MRCTs) and ...

03 July 2015

Drug companies that want to offer payers a more attractive price to secure market access for their new innovations should try a whole new approach to R&D. Step away from the randomized control trial (RCT), consult with patients and exploit data ...

02 July 2015

Chinese regulators need to learn from international regulatory experience on how to shorten timeframes for drug applicants', according to Wang Tao, deputy director of the China Food and Drug Administration?s Center for Drug Review. In particular, ...

01 July 2015

As the European Medicines Agency prepares to implement its policy on the proactive publication of clinical trial data, it is bracing itself for the inevitable disputes with pharmaceutical companies on what constitutes commercially confidential ...

01 July 2015

With its emphasis on involving a range of key stakeholders in discussions at a very early stage in the drug development process, the adaptive pathways approach to drug evaluation and market access being spearheaded by the European Medicines Agency ...

26 June 2015

Does loss of hearing with age affect people?s comprehension of direct-to-consumer (DTC) prescription drug television ads? That?s the latest question the Office of Prescription Drug Promotion at the US Food and Drug Administration is addressing in ...

26 June 2015

Reprocessed and re-used life-sustaining and life-supporting devices in the US - regardless of their classification - will need to have unique device identifiers (UDI) directly marked on them by September 2016, according to a new Food and Drug ...

26 June 2015

Medicines Australia has expressed its disappointment at the decision by the country's health minister not to sign a strategic agreement that would have provided the Australian R&D-based pharmaceutical industry with some policy stability over the ...

25 June 2015

Roche is refusing to play any part in French government efforts to make its anticancer Avastin available for off-label use in wet AMD under a "temporary use recommendation" (RTU), saying that it goes against the product's labeling and that other ...

22 June 2015

Another European court ruling has confirmed the important role of the EU orphan drug regulation in encouraging companies to conduct R&D into medicines for rare diseases, and helped to clarify the rules regarding the orphan market exclusivity ...

11 June 2015

Before applying for an interim injunction in the UK, pharmaceutical companies may want to take note of a recent Court of Appeal ruling that upheld a 27m damages award made to Krka and Consilient in compensation for delays to the launch of their ...

08 June 2015

Swiss claims are in the news again. No, not the allegations of corruption and bribery laid at FIFA's door, but the latest ruling from the Court of Appeal in the UK Lyrica (pregabalin) patent case 1 . In its 28 May ruling, which concerned the ...

 
29 June 2015
Ian Schofield
Roche has locked horns with the ANSM, the French healthcare products regulatory agency, over the latter's plans to make Roche's Avastin available off-label for wet AMD. It's not easy to say who will emerge the winner. Taking advantage of a 2014 law ...
 
07 November 2014
Maureen Kenny
The appointment of Professor Sir Michael Rawlins as chair of the UK Medicines and Healthcare ...
 
23 June 2015
Ariye Sidi explains how the approval process for clinical trials in Brazil has improved over the ...
22 June 2015
Thomas Hirse and Shuna Mason consider the regulatory and practical requirements for pharmaceutical ...
11 June 2015
The IEC 60601-1 standard on medical electric equipment is a critical tool for many medical ...
 
 
12 November 2013
Joint assessments by national designating authorities in the EU of notified bodies active in the medical device area are relatively new. A voluntary ...
28 August 2013
Ken Daly looks to the US to predict what could happen in Europe if the European Commission's recommendation for an EU-wide class action system is ...
05 July 2013
The French medtech market is already highly regulated and complex and is becoming more so. While the CE marking should act as a single passport to ...
 
The EMA at 20, what's it all about?
17 April 2015
 
EU electromedical industry association COCIR gets new president The European radiological, electromedical and healthcare IT industry association, COCIR, has appointed Joost Leeflang from ...
New MITA regulatory director to promote imaging standards adoption The US Medical Imaging & Technology Alliance has appointed Megan Hayes as its regulatory and standards director 1 . In her ...
 
   
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