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RECENT TWEETS    
06 May 2016

 
05 May 2016

As Health Canada prepares to kick-start in 2017 its two-year plan to fully adopt the Medical Device Single Audit Program (MDSAP) in place of the current Canadian Medical Devices Conformity Assessment System (CMDCAS), the local medtech industry ...

05 May 2016

The government commission conducting an inquiry into Australia's intellectual property system has produced an interim report in which it makes a number of recommendations on data exclusivity and patent term extensions that are guaranteed to have the ...

05 May 2016

The use of nanomaterials and endocrine disruptors in medical devices are among the main work items for the European Commission's Scientific Committee on Health Environmental and Emerging Risks over its next, five-year term (2016-2021), it emerged at ...

05 May 2016

The US Food and Drug Administration is hoping that a standardized continuous manufacturing platform will entice the generics industry to embrace the new production approach. Brand companies are already becoming interested in the continuous ...

05 May 2016

As Health Canada prepares to kick-start in 2017 its two-year plan to fully adopt the Medical Device Single Audit Program (MDSAP) in place of the current Canadian Medical Devices Conformity Assessment System (CMDCAS), the local medtech industry ...

05 May 2016

The government commission conducting an inquiry into Australia's intellectual property system has produced an interim report in which it makes a number of recommendations on data exclusivity and patent term extensions that are guaranteed to have the ...

05 May 2016

The use of nanomaterials and endocrine disruptors in medical devices are among the main work items for the European Commission's Scientific Committee on Health Environmental and Emerging Risks over its next, five-year term (2016-2021), it emerged at ...

05 May 2016

The US Food and Drug Administration is hoping that a standardized continuous manufacturing platform will entice the generics industry to embrace the new production approach. Brand companies are already becoming interested in the continuous ...

05 May 2016

As Health Canada prepares to kick-start in 2017 its two-year plan to fully adopt the Medical Device Single Audit Program (MDSAP) in place of the current Canadian Medical Devices Conformity Assessment System (CMDCAS), the local medtech industry ...

05 May 2016

The US Food and Drug Administration is hoping that a standardized continuous manufacturing platform will entice the generics industry to embrace the new production approach. Brand companies are already becoming interested in the continuous ...

05 May 2016

Biocompatibility testing of device materials is a challenge faced by many device manufacturers, and it is a key element of many pre-market notification (510(k)) and pre-market approval (PMA) applications coming before the US Food and Drug ...

05 May 2016

A key working group at the European Commission has approved major changes to the current guideline on clinical evaluation of medical devices (MEDDEV 2.7/1, Rev 3) 1 , including stricter requirements for demonstrating equivalency between a device ...

03 May 2016

April saw the 10th anniversary of the first biosimilar approval in Europe - Sandoz' Omnitrope (somatropin) - which was launched in 2006. But a decade on, even with 20 biosimilar products now available and many more to come as big biological drugs ...

28 April 2016

The Indian government has issued orders to appoint an inter-ministerial committee to restrict the import of refurbished radiology devices and to examine whether to stop such imports, the approval requirements that are in place for such products, ...

20 April 2016

After the European Medicines Agency's pharmacovigilance committee (PRAC) finalized rules on how it would conduct public hearings to support the safety review of certain marketed medicines earlier this month 1-3 , medicines advocacy group Health ...

15 April 2016

In what can be seen as an example of the benefits of EU-wide research projects in the life science area, the European Medicines Agency says that the public-private PROTECT project, which ran for five years from late 2009 to early 2015, is already ...

05 May 2016

The government commission conducting an inquiry into Australia's intellectual property system has produced an interim report in which it makes a number of recommendations on data exclusivity and patent term extensions that are guaranteed to have the ...

21 April 2016

Geneviève Michaux explores the complicated business of obtaining rewards available under the EUPaediatric Regulation. A new judgment by a court in Europe that former orphan medicinal products may benefit from a six-month paediatric extension of the ...

07 April 2016

GlaxoSmithKline PLC and Teva Pharmaceutical Industries Ltd. are urging the US Supreme Court to clarify that its 2013 opinion on reverse payment settlements does not cover agreements in which the brand name drug maker promises not to launch an ...

 
22 April 2016
Ashley Yeo
The big event for the UK, of this or any year, will happen in nine weeks' time. The referendum on the UK's continued membership of the European Union is set for June 23, as promised by the Conservative party after it won the 2015 general ...
 
07 July 2015
Maureen Kenny
Regulators face a difficult balancing act in the debate over how to get innovative medicines to ...
 
01 May 2016
Trial master files (TMFs) provide evidence that drug sponsors complied with regulations and ...
28 April 2016
The UK's early access to medicines scheme (EAMS) has been operational for two years, along with a ...
21 April 2016
What is the interplay between regulatory requirements and liability associated with alleged defects ...
 
MOST READ
 
The EMA at 20, what's it all about?
17 April 2015
 
Next AdvaMed Chief Is BIO Exec Scott Whitaker US medical device industry association AdvaMed has appointed Scott Whitaker as its next president and CEO 1 . Whitaker, ...
European Biosimilars Trade Group Appoints New Leadership Team The European Biosimilar medicines Group (EBG) has elected Carol Lynch as Chair of the overall sector group and Klaus Martin ...
 
   
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