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27 February 2015

 
27 February 2015

The European Medicines Agency is going all electronic, at least as far as drug applications are concerned 1 ,2 . From 1 July this year, all companies submitting applications to the EMA via the centralized authorization procedure (human and ...

27 February 2015

The US Food and Drug Administration is to host a public workshop to gather feedback on the clinical and scientific challenges associated with the regulation of robotically-assisted surgical (RAS) devices 1 . The FDA says there are several challenges ...

27 February 2015

The US Food and Drug Administration has been called on to explain when its long-overdue drug guidance on the so-called animal rule is likely to be finalized. It has been nearly two years since Congress passed a measure requiring the FDA to issue the ...

26 February 2015

An international guidance document to help manufacturers of advanced therapy medicinal products (ATMPs) tackle the tricky business of selecting the appropriate raw materials is likely to be finalized by mid-March. The guidance (PAS 157) aims to ...

27 February 2015

The European Medicines Agency is going all electronic, at least as far as drug applications are concerned 1 ,2 . From 1 July this year, all companies submitting applications to the EMA via the centralized authorization procedure (human and ...

27 February 2015

The US Food and Drug Administration is to host a public workshop to gather feedback on the clinical and scientific challenges associated with the regulation of robotically-assisted surgical (RAS) devices 1 . The FDA says there are several challenges ...

27 February 2015

The US Food and Drug Administration has been called on to explain when its long-overdue drug guidance on the so-called animal rule is likely to be finalized. It has been nearly two years since Congress passed a measure requiring the FDA to issue the ...

26 February 2015

An international guidance document to help manufacturers of advanced therapy medicinal products (ATMPs) tackle the tricky business of selecting the appropriate raw materials is likely to be finalized by mid-March. The guidance (PAS 157) aims to ...

27 February 2015

The European Medicines Agency is going all electronic, at least as far as drug applications are concerned 1 ,2 . From 1 July this year, all companies submitting applications to the EMA via the centralized authorization procedure (human and ...

27 February 2015

The US Food and Drug Administration is to host a public workshop to gather feedback on the clinical and scientific challenges associated with the regulation of robotically-assisted surgical (RAS) devices 1 . The FDA says there are several challenges ...

27 February 2015

The US Food and Drug Administration has been called on to explain when its long-overdue drug guidance on the so-called animal rule is likely to be finalized. It has been nearly two years since Congress passed a measure requiring the FDA to issue the ...

26 February 2015

An international guidance document to help manufacturers of advanced therapy medicinal products (ATMPs) tackle the tricky business of selecting the appropriate raw materials is likely to be finalized by mid-March. The guidance (PAS 157) aims to ...

25 February 2015

After the legislative upheavals in France and Italy, the Avastin v Lucentis saga has reared its head again in the UK, after clinical commissioning groups (CCGs) called on the government and NHS England to support doctors wanting to prescribe Roche's ...

24 February 2015

An EU task force is to be set up to discuss how new standards for the identification of medicinal products (IDMP) are to be implemented 1 . The European Medicines Agency, which wants industry and other stakeholders to be part of the task force, says ...

19 February 2015

The healthcare product agencies in Switzerland and China have signed a bilateral agreement to boost their collaboration on the regulation of medical devices and medicines and facilitate patient access to products in their respective countries 1 ,2 ...

19 February 2015

The European Medicines Agency has started translating into all EU languages the recommendations its Pharmacovigilance Risk Assessment Committee issues on the changes that should be made to product information based on the assessment of safety ...

26 January 2015

The judgement by a High Court judge that the launch by Actavis of a generic version of Pfizer's Lyrica (pregabalin) in the UK would not infringe a patent held by Pfizer company Warner-Lambert on one of the three uses for which Lyrica is approved 1,2 ...

19 January 2015

Companies are finally set to get legal clarity on one of the biggest causes of contention between the pharma industry and Brazilian authorities. The courts will eventually decide on the legality of the medicine regulator's role in vetoing patent ...

19 December 2014

In a decision that will be welcomed by the biotechnology industry, the Court of Justice of the EU has ruled that a parthenote - an unfertilized human ovum stimulated to grow by parthenogenesis - is not capable of developing into a human being and so ...

 
20 January 2015
Ashley Yeo
It?s decision year for the proposed EU Medical Device Regulation , and by the end of 2015 its final shape should be known. That is if the current Council of the EU deadlines (below) under the Latvian presidency and the subsequent talks with the ...
 
07 November 2014
Maureen Kenny
The appointment of Professor Sir Michael Rawlins as chair of the UK Medicines and Healthcare ...
 
20 February 2015
Daniel Kracov discusses the controversy surrounding the US Food and Drug Administration's proposals ...
18 February 2015
Valerie Surgenor and Craig Houston explore the changes two new EU regulations affecting the medical ...
18 February 2015
The EU Regulatory Intelligence Network Group explains how the regulatory intelligence function can ...
 
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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 ...
 
A candid look at the European drug regulatory network from Jytte Lyngvig, CEO of the Danish Medicines Agency 2000-2012
18 January 2013
 
UK MHRA appoints chairman for new medtech advisory committee The UK Medicines and Healthcare products Regulatory Agency has appointed Peter Nightingale as chairman of its ...
UK pharma industry group ABPI announces new president The Association of the British Pharmaceutical Industry has appointed John Kearney president of the association. He will ...
 
   
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