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07 March 2015

 
06 March 2015

In the latest in our series marking the European Medicines Agency's 20th anniversary*, Ian Schofield looks at the agency's achievements ? and areas where it has faced problems ? over the past two decades. The EMA began life on 26 January 1995 as ...

06 March 2015

The French healthcare products regulator ANSM has laid out a wide-ranging set of plans in its work program for 2015, including guaranteeing the safety of drugs and medical devices, ensuring rapid and wider access to drug innovation, and using ...

06 March 2015

Health Canada has warned drug manufacturers that it is increasing the frequency at which it carries out planned and surprise inspections of facilities and that, starting April, it will make more of its findings available to the public 1 . The ...

06 March 2015

The World Health Organization is inviting feedback on proposed changes to its good manufacturing practice requirements for biological products 1 . The WHO's GMP requirements for biological products are outlined in the organization's technical report ...

06 March 2015

Ireland's Health Products Regulatory Authority has begun formulating its goals and activities for 2016-2020 and is inviting comments on the issues and priorities it should consider 1 . The HPRA has issued for consultation a strategic document for ...

06 March 2015

In the latest in our series marking the European Medicines Agency's 20th anniversary*, Ian Schofield looks at the agency's achievements ? and areas where it has faced problems ? over the past two decades. The EMA began life on 26 January 1995 as ...

06 March 2015

The French healthcare products regulator ANSM has laid out a wide-ranging set of plans in its work program for 2015, including guaranteeing the safety of drugs and medical devices, ensuring rapid and wider access to drug innovation, and using ...

06 March 2015

Health Canada has warned drug manufacturers that it is increasing the frequency at which it carries out planned and surprise inspections of facilities and that, starting April, it will make more of its findings available to the public 1 . The ...

06 March 2015

Health Canada has warned drug manufacturers that it is increasing the frequency at which it carries out planned and surprise inspections of facilities and that, starting April, it will make more of its findings available to the public 1 . The ...

06 March 2015

The World Health Organization is inviting feedback on proposed changes to its good manufacturing practice requirements for biological products 1 . The WHO's GMP requirements for biological products are outlined in the organization's technical report ...

06 March 2015

The Irish Health Products Regulatory Authority has revised its guidance for medical device companies applying for certificates of free sale. The updated guidance increases the number of documents companies must submit and imposes a new limit of 30 ...

05 March 2015

The EMA is ahead of the curve in addressing the concerns of patients, consumers and health professionals, but when it comes to independence, transparency and stimulating innovation, the agency still has a long way to go, say Tim Reed and Ancel.la ...

06 March 2015

The Irish Health Products Regulatory Authority has revised its guidance for medical device companies applying for certificates of free sale. The updated guidance increases the number of documents companies must submit and imposes a new limit of 30 ...

03 March 2015

UK drug regulators remain sanguine in the face of claims that self-regulation by the pharmaceutical industry of its promotional and marketing practices is failing after a study found that companies violate their codes of practice time and again. The ...

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 ...

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 ...

 
11 December 2014
Ashley Yeo
As medical device regulatory systems - and users' understanding of them - have matured, so has the relationship between the regulators and the regulated. The entrenched 'us and them' positioning that might once have held sway has over time given way ...
 
07 November 2014
Maureen Kenny
The appointment of Professor Sir Michael Rawlins as chair of the UK Medicines and Healthcare ...
 
03 March 2015
Adrian Murray analyzes the conflicts in case law of the European Patent Office and UK court ...
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 ...
 
MOST READ
 
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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