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28 November 2014

Chinese regulators are proposing to introduce a host of new requirements for international drug companies that conduct multi-regional clinical trials (MRCTs) involving study sites in China 1 ,2 . The new requirements, contained in a newly issued ...

28 November 2014

'Almost all' member states representatives at the Council of the European Union believe the contentious 'scrutiny' procedure for high-risk and innovative medical devices as proposed by the European Commission would be impossible to apply 1 . That is ...

28 November 2014

As the year starts drawing to a close, the EU?s adoption of the new medical device and IVD regulations is still nowhere in sight. It seems that the member states of the Council of the European Union are finding it too challenging to reach an ...

28 November 2014

The World Health Organization has faced more criticism that its statement on disclosing clinical trial data does not go far enough if it really wants to make a difference ? this time from Germany's health technology appraisal body, IQWiG . Among ...

28 November 2014

Chinese regulators are proposing to introduce a host of new requirements for international drug companies that conduct multi-regional clinical trials (MRCTs) involving study sites in China 1 ,2 . The new requirements, contained in a newly issued ...

28 November 2014

'Almost all' member states representatives at the Council of the European Union believe the contentious 'scrutiny' procedure for high-risk and innovative medical devices as proposed by the European Commission would be impossible to apply 1 . That is ...

28 November 2014

As the year starts drawing to a close, the EU?s adoption of the new medical device and IVD regulations is still nowhere in sight. It seems that the member states of the Council of the European Union are finding it too challenging to reach an ...

28 November 2014

The World Health Organization has faced more criticism that its statement on disclosing clinical trial data does not go far enough if it really wants to make a difference ? this time from Germany's health technology appraisal body, IQWiG . Among ...

28 November 2014

Chinese regulators are proposing to introduce a host of new requirements for international drug companies that conduct multi-regional clinical trials (MRCTs) involving study sites in China 1 ,2 . The new requirements, contained in a newly issued ...

28 November 2014

'Almost all' member states representatives at the Council of the European Union believe the contentious 'scrutiny' procedure for high-risk and innovative medical devices as proposed by the European Commission would be impossible to apply 1 . That is ...

28 November 2014

The World Health Organization has faced more criticism that its statement on disclosing clinical trial data does not go far enough if it really wants to make a difference ? this time from Germany's health technology appraisal body, IQWiG . Among ...

27 November 2014

Few people in the drug regulatory sphere can be unaware of the travails that have beset the European Medicines Agency's controversial policy on the proactive disclosure of clinical trial data, which has been two and a half years in the making and ...

25 November 2014

Changes to regulatory procedures can be unsettling at the best of times, and the past couple of years have brought the drug industry and regulators in Europe more than their fair share of new structures, processes and obligations. A host of new ...

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 ...

24 November 2014

The UK's 'Patent Box', a much vaunted tool intended to help make the UK a more competitive environment for business, will have to be modified after the UK and Germany reached an agreement intended to address criticisms of the UK scheme and similar ...

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 . ...

 
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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