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22 May 2012

The heads of the US Senate Health, Education, Labor, and Pensions (HELP) Committee on 21 May urged their fellow lawmakers not to bog down the legislation intended to reauthorise the drug and medical device user fee programmes for the US Food and ...

28 February 2012

Phil Greenfield reports on evidence that suggests that more and more companies regard sub-Saharan Africa as a viable and stable long-term market. At Ask the Analyst, a client research and consultation service offered exclusively to subscribers of ...

01 February 2012

The Kenyan Pharmacy and Poisons Board has issued guidance explaining the current minimum requirements for advertising and promoting drugs and medical devices in the country 1 . The guideline stipulates, among other things, the procedures that ...

21 May 2012

Neena Brizmohun reports on progress being made by the tripartite initiative. An initiative that involves Japan, China and South Korea co-operating on clinical trials for drugs has made three important advances relating to its aim of facilitating ...

16 May 2012

China and India remain on the priority watch list of countries that the US says cause the "most significant" concern in terms of insufficient intellectual property rights (IPR) protection or enforcement or limited market access for those relying on ...

22 May 2012

Pharmaceutical companies hoping for improvements in the Russian clinical trial environment will be encouraged by a provision in a recent draft law aimed at abolishing the requirement for foreign firms to carry out local trials when seeking a new ...

22 May 2012

England's Department of Health has rejected a news report claiming that it has again marginalised the role of the National Institute for Health and Clinical Excellence ( NICE ), the health technology appraisal body for England and Wales, under the ...

22 May 2012

The International Conference on Harmonisation has finalised a guideline explaining quality-related requirements for developing and manufacturing drug substances, both chemical and biotechnological/biological entities 1 ,2 . The guideline fills a ...

17 May 2012

The International Conference on Harmonisation has approved plans for developing a new guideline on rodent carcinogenicity testing of human drugs 1 . The document, when finalised and adopted, could result in fewer drugs requiring two-year rodent ...

11 May 2012

Brazil is proposing to fast-track a large proportion of applications it receives for clinical trials of medicines and devices to be conducted in the country 1 . International studies that have already been approved in the EU, the US, Japan, ...

25 April 2012

From April 2013, the registered marketers of all medical devices in Brazil will be subject to new legal obligations affecting adverse event reporting requirements and corrective actions relating to their products 1 . The various field actions that ...

22 May 2012

The heads of the US Senate Health, Education, Labor, and Pensions (HELP) Committee on 21 May urged their fellow lawmakers not to bog down the legislation intended to reauthorise the drug and medical device user fee programmes for the US Food and ...

21 May 2012

When the US Supreme Court invalidated diagnostic methods patents held by Prometheus Laboratories in a 20 March decision, John Whealan, associate dean for intellectual property law studies at George Washington Law School, said he found himself in the ...

 
25 April 2012
Ian Haydock
Japan is beginning to intensify political debate on a formal system for the "compassionate use" of unapproved drugs, in a move that might bring it into line with similar schemes in the US and EU. The key word is "might", as it remains far from clear ...
 
23 February 2012
Amanda Maxwell
The European Diagnostics Manufacturers Association is at a pivotal junction in its history. Among other things, intense discussions over the proposed revision of the In Vitro Diagnostics Directive are underway and EDMA's management structure is ...
 
22 May 2012
Matthew Royle and Helen Cline consider the latest legal opinion from the EU on the interpretation of the SPC legislation to be good news for companies investing in research to investigate new formulations and uses of known active ingredients but ...
21 May 2012
Neena Brizmohun reports on progress being made by the tripartite initiative. An initiative that involves Japan, China and South Korea co-operating on clinical trials for drugs has made three important advances relating to its aim of facilitating ...
18 May 2012
Planned change on the choice of reference product for biosimilars in the EU means global development is on the agenda. Maureen Kenny reports from the EGA biosimilars conference in London. The EU is preparing for a major change in biosimilars ...
 
Regulatory Affairs Medtech News Roundup, December 2010
09 December 2010
 
EU pharma excipients industry association gets new secretary general The European chapter of the International Pharmaceutical Excipients Council has appointed Laurent Boll as its new secretary general 1 . Mr Boll's appointment was cleared by IPEC Europe's board on 15 May. A graduate from the University of Maastricht ...
EU qualified persons association recruits new members The European Association of Qualified Persons has nominated two new members to its board. The latest nominees are Ulrich Kissel of Roche (Germany) and Edit Sz?cs from the Hungarian National Institute of Pharmacy (NIP) 1 . Dr Kissel has more than 15 ...
 
   
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