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31 October 2014

 
31 October 2014

The revised version of the European Medicines Agency's general guideline on biosimilar medicines has now been published, complete with a number of changes from the original, including the possibility of using a non-EU comparator drug in order to ...

31 October 2014

EU medtech industry associations Eucomed and EDMA are recommending that their member companies phase out by 1 January 2018 direct industry sponsorship of healthcare professionals (HCPs) to third-party organized conferences 1 ,2 . Medical device ...

30 October 2014

The European Medicines Agency said GlaxoSmithKline's experimental Ebola vaccine is the first product to undergo a new regulatory process aimed at allowing companies developing products against the deadly virus to receive "rapid scientific advice" ...

29 October 2014

Drug firms that are anxiously waiting to hear how plans by the European Medicines Agency to review and possibly revoke class waivers for pediatric investigation plans (PIPs) are proceeding may soon get a hint of what is to come. The issue of class ...

31 October 2014

The revised version of the European Medicines Agency's general guideline on biosimilar medicines has now been published, complete with a number of changes from the original, including the possibility of using a non-EU comparator drug in order to ...

31 October 2014

EU medtech industry associations Eucomed and EDMA are recommending that their member companies phase out by 1 January 2018 direct industry sponsorship of healthcare professionals (HCPs) to third-party organized conferences 1 ,2 . Medical device ...

30 October 2014

The European Medicines Agency said GlaxoSmithKline's experimental Ebola vaccine is the first product to undergo a new regulatory process aimed at allowing companies developing products against the deadly virus to receive "rapid scientific advice" ...

29 October 2014

Rami Rajab, chairman of the medical device and diagnostics trade association for the Middle East and North Africa, Mecomed, tells Amanda Maxwell why regulatory compliance is the key to success in these regions. There is a population of some 650 ...

31 October 2014

The revised version of the European Medicines Agency's general guideline on biosimilar medicines has now been published, complete with a number of changes from the original, including the possibility of using a non-EU comparator drug in order to ...

30 October 2014

The European Medicines Agency said GlaxoSmithKline's experimental Ebola vaccine is the first product to undergo a new regulatory process aimed at allowing companies developing products against the deadly virus to receive "rapid scientific advice" ...

29 October 2014

Drug firms that are anxiously waiting to hear how plans by the European Medicines Agency to review and possibly revoke class waivers for pediatric investigation plans (PIPs) are proceeding may soon get a hint of what is to come. The issue of class ...

28 October 2014

A small group of experts is to conduct an independent assessment of Australia's Therapeutic Goods Administration with a view to streamlining the agency's regulatory processes for medicines and medical devices, improving access to medicines, and ...

31 October 2014

EU medtech industry associations Eucomed and EDMA are recommending that their member companies phase out by 1 January 2018 direct industry sponsorship of healthcare professionals (HCPs) to third-party organized conferences 1 ,2 . Medical device ...

29 October 2014

Rami Rajab, chairman of the medical device and diagnostics trade association for the Middle East and North Africa, Mecomed, tells Amanda Maxwell why regulatory compliance is the key to success in these regions. There is a population of some 650 ...

28 October 2014

China has traditionally been a key exporter of low-risk devices to the US but the US Food and Drug Administration is now expecting to see a heavier, incoming flow of China-manufactured, Class 3 devices. In response, both the US agency and the China ...

21 October 2014

The UK Medicines and Healthcare Products Regulatory Agency is inviting drug companies to test more widely a new scheme on co-ordinated submission and assessment of variations and changes to the packaging/patient information leaflet that are ...

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 ...

 
29 October 2014
Amanda Maxwell
The European medical devices industry urgently needs transparency on the new medical device and IVD regulations that are making their way through the complex EU legislative process but there is no telling at present just how long it will take the ...
 
11 February 2014
Maureen Kenny
?If you don?t finance it correctly, it will implode.? This was the stark warning key European drug ...
 
31 October 2014
The new EU Clinical Trials Regulation has had a largely positive reception, but it leaves a lot of ...
24 October 2014
Mike Snodin explains why patent offices do not need to seek guidance from the Court of Justice of ...
22 October 2014
The Republic of Moldova took a step forward in its pursuit of EU membership in June, when it signed ...
 
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
 
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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