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FEATURED CONTENT
01 April 2015

EXCLUSIVE EMA 20th anniversary supplement
18 March 2015

To mark the 20th anniversary of the European Medicines Agency, Scrip Intelligence and Scrip Regulatory Affairs invited a wide range of people with an interest in the work of the agency and drug regulation to air their views on the achievements of the EMA, its shortcomings, and its place in the future EU regulatory environment.

 
31 March 2015

The European Medicines Agency has pledged to review "in the shortest possible time" drug companies' paediatric investigation plans (PIPs) and any related PIP modifications for medicinal products designed for the treatment and prevention of Ebola. In ...

31 March 2015

Simply click on the links to access the documents. Country Organization Title Status International WHO WHO GMP for Biological Products. Proposed replacement of: TRS 822, Annex 1 Draft Canada HC Amendments to the Food and Drugs Act: Guide to ...

31 March 2015

The European Medicines Agency's Committee for Advanced Therapy Medicinal Products (CAT) evaluates the quality, safety and efficacy of ATMPs. Senior Finnish regulator Paula Salmikangas* has chaired the committee since February 2014. In this profile, ...

30 March 2015

One of last year's most disruptive events for the European Medicines Agency was the loss of its executive director Guido Rasi, who had to step aside in November after the EU's civil service tribunal annulled the procedure that led to his appointment ...

31 March 2015

The European Medicines Agency has pledged to review "in the shortest possible time" drug companies' paediatric investigation plans (PIPs) and any related PIP modifications for medicinal products designed for the treatment and prevention of Ebola. In ...

31 March 2015

Simply click on the links to access the documents. Country Organization Title Status International WHO WHO GMP for Biological Products. Proposed replacement of: TRS 822, Annex 1 Draft Canada HC Amendments to the Food and Drugs Act: Guide to ...

31 March 2015

The European Medicines Agency's Committee for Advanced Therapy Medicinal Products (CAT) evaluates the quality, safety and efficacy of ATMPs. Senior Finnish regulator Paula Salmikangas* has chaired the committee since February 2014. In this profile, ...

30 March 2015

One of last year's most disruptive events for the European Medicines Agency was the loss of its executive director Guido Rasi, who had to step aside in November after the EU's civil service tribunal annulled the procedure that led to his appointment ...

31 March 2015

The European Medicines Agency has pledged to review "in the shortest possible time" drug companies' paediatric investigation plans (PIPs) and any related PIP modifications for medicinal products designed for the treatment and prevention of Ebola. In ...

30 March 2015

In her final public address as commissioner of the US Food and Drug Administration , Margaret Hamburg urged stakeholders to put their collaborative efforts towards strengthening, rather than undermining, the agency she led for almost six years. "It ...

26 March 2015

If Japan needed any reassurance that it was pursuing the right policy path, at least in the pharma/biotech area, plenty was forthcoming at the BIO Asia 2015 conference in Tokyo 1 . Jim Greenwood, president and CEO of meeting organizer, the US ...

24 March 2015

US medtech industry association AdvaMed believes that the Food and Drug Administration's annual list of medical device guidelines it plans to issue in this fiscal year misses out some important guidelines that are of high priority to industry ...

26 March 2015

France has fulfilled its promise to make Roche's anticancer drug Avastin (bevacizumab) available off-label to treat wet age-related macular degeneration (AMD), even though two other products ? Novartis's Lucentis (ranibizumab) and Bayer's Eylea ...

24 March 2015

An initiative that is being supported by the EU Heads of Medicines Agencies will soon be in place to help pharmaceutical companies in preparing risk management plans (RMPs) and assist EU member states in assessing these documents. Under the ...

23 March 2015

The Indian government has accepted the local medical device industry association's request to extend the pharmaceutical sector's voluntary code on ethical marketing practices to all medtech companies. The Association of India Medical Device ...

18 March 2015

The US Food and Drug Administration is organizing a public workshop to address concerns that cancer patients may not be receiving adequate care where multiple companion diagnostics are available for different drugs in a single therapeutic product ...

23 March 2015

A US District Court has ruled that Novartis unit Sandoz did nothing wrong by not engaging in the disclosure and dispute resolution process laid out by the Biologics Price Competition and Innovation Act ? the law that established the abbreviated ...

11 March 2015

The Court of Justice of the European Union has delivered a preliminary ruling on defective medical devices that could introduce new costs for manufacturers. The CJEU ruled that where a medical device has a potential defect based on quality control ...

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 ...

 
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 ...
 
24 March 2015
Mike Snodin discusses recent decisions on second medical use patents in Europe and the important ...
11 March 2015
Big data, mobile health and synthetic biology are already driving huge innovation in the healthcare ...
03 March 2015
Adrian Murray analyzes the conflicts in case law of the European Patent Office and UK court ...
 
 
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
 
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 ...
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 ...
 
   
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