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21 November 2014

Australia and New Zealand have once again ditched plans for a joint drug and medical device regulator, wiping away all efforts made in the last three years to harmonize the two countries? regulatory frameworks to create the Australia New Zealand ...

21 November 2014

Drug companies wishing to take part in the European Medicines Agency's adaptive licensing pilot will need to get their skates on if they want to be considered as candidates. The EMA has announced that Phase I of the pilot will close at the end of ...

21 November 2014

The Asian Harmonization Working Party is presenting for endorsement at its 19 th annual meeting this week five documents covering key aspects of medical device regulation and an application from Tanzania to join the AHWP as a member economy 1 . The ...

20 November 2014

Some groups were having trouble swallowing the $2.6bn figure US researchers from the drug industry-funded Tufts Center for the Study of Drug Development (CSDD) declared on 18 November as the cost of developing a new prescription medicine 1 ,2 . The ...

21 November 2014

Australia and New Zealand have once again ditched plans for a joint drug and medical device regulator, wiping away all efforts made in the last three years to harmonize the two countries? regulatory frameworks to create the Australia New Zealand ...

21 November 2014

Drug companies wishing to take part in the European Medicines Agency's adaptive licensing pilot will need to get their skates on if they want to be considered as candidates. The EMA has announced that Phase I of the pilot will close at the end of ...

21 November 2014

The Asian Harmonization Working Party is presenting for endorsement at its 19 th annual meeting this week five documents covering key aspects of medical device regulation and an application from Tanzania to join the AHWP as a member economy 1 . The ...

20 November 2014

Some groups were having trouble swallowing the $2.6bn figure US researchers from the drug industry-funded Tufts Center for the Study of Drug Development (CSDD) declared on 18 November as the cost of developing a new prescription medicine 1 ,2 . The ...

21 November 2014

Drug companies wishing to take part in the European Medicines Agency's adaptive licensing pilot will need to get their skates on if they want to be considered as candidates. The EMA has announced that Phase I of the pilot will close at the end of ...

20 November 2014

Some groups were having trouble swallowing the $2.6bn figure US researchers from the drug industry-funded Tufts Center for the Study of Drug Development (CSDD) declared on 18 November as the cost of developing a new prescription medicine 1 ,2 . The ...

19 November 2014

As of 1 December, it will be mandatory in Canada for manufacturers of class III and IV medical devices to submit their licence applications in electronic format 1 . The acceptance by Health Canada of electronic-only submissions marks a step in ...

18 November 2014

Clinical evidence requirements are among the new rules that are going to have the biggest impact on the IVD industry once the forthcoming EU IVD Regulation eventually takes effect. IVD manufacturers would do well to make use of the transition period ...

14 November 2014

US drug shortages could be one of the unintended consequences if the Food and Drug Administration does not allow some enforcement discretion in the beginning of 2015 as the first set of drug tracing requirements - the handoff of transaction ...

13 November 2014

Singapore's Health Sciences Authority is seeking comments on a proposal to replace its pre-approval system for drug advertisements with a new mechanism that would allow the pharmaceutical industry to self-regulate based on a set of rules and guiding ...

10 November 2014

Australia's Therapeutic Goods Administration has proposed revisions to its guideline on the antimicrobial resistance risk data that antibacterial medicinal product makers should submit in their marketing applications to the agency 1 ,2 . The ...

07 November 2014

Tuberculosis, HIV/AIDS and now Ebola: the developing world is facing a string of public health challenges, while on the other hand, the cost of innovative new therapies such as hepatitis C treatment Sovaldi (sofosbuvir) is so high that few in the ...

06 October 2014

All enterprises must disclose administrative penalty information in a timely manner or face a ban from public procurement, China has said. The rule could significantly change risk profiles for multinational healthcare companies in the country, say ...

01 October 2014

GlaxoSmithKline's Chinese bribery scandal ? which last month ended with the UK major being fined a record sum of nearly $490 million ? has left the pharma industry pondering its next steps to meet a rising bar and the soaring costs of compliance 1 . ...

29 September 2014

The European Medicines Agency is hoping to get a final decision from its management board on 2 October on its eagerly-awaited policy on proactive publication of clinical trial data. If things go as planned, the policy could come into effect next ...

 
12 November 2014
Ashley Yeo
In view of the planned risk classification changes in the forthcoming EU In Vitro Diagnostics Regulation , and the fact that nearly all IVDs will need the input of notified bodies, manufacturers who want to ensure their products remain on the EU ...
 
07 November 2014
Maureen Kenny
The appointment of Professor Sir Michael Rawlins as chair of the UK Medicines and Healthcare ...
 
21 November 2014
When Scrip Regulatory Affairs editor Maureen Kenny interviewed Ian Hudson, the chief executive of ...
07 November 2014
France has seen the worst of the recent healthcare products scandals and the medtech industry has ...
06 November 2014
Inna Demidova discusses current and upcoming regulatory requirements for pharmaceutical companies ...
 
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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
 
US FDA's drugs center gets permanent regulatory policy head The US Food and Drug Administration has promoted Grail Sipes to permanent director of its Office of Regulatory Policy at ...
Law enforcement expert named as new compliance chief at US FDA drug center The US Food and Drug Administration has hired Cynthia Schnedar as the new head of compliance at its Center for Drug ...
 
   
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