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14 February 2016

 
12 February 2016

The World Health Organization has issued draft guidance on what changes relating to IVDs that fall under its prequalification program manufacturers must report to the WHO, what changes do not need reporting, and what changes might require a new ...

12 February 2016

The European Commission is planning to set up a network of experts from the EU member states to work on a set of guidelines on the prudent use of antimicrobials, and will also work internally and with the European Medicines Agency on ways of ...

12 February 2016

A senior official of the European Medicines Agency is to be an observer on the new French committee set up to look at the preclinical and clinical characteristics of FAAH inhibitors following the death of one volunteer and the hospitalization of ...

11 February 2016

The US Food and Drug Administration's Arthritis Advisory Committee has overwhelmingly endorsed approval of Celltrion Inc.'s biosimilar Inflectra (CT-P13) and has urged the agency to recognize the concept of data extrapolation 1 ,2 . The committee ...

12 February 2016

The World Health Organization has issued draft guidance on what changes relating to IVDs that fall under its prequalification program manufacturers must report to the WHO, what changes do not need reporting, and what changes might require a new ...

12 February 2016

The European Commission is planning to set up a network of experts from the EU member states to work on a set of guidelines on the prudent use of antimicrobials, and will also work internally and with the European Medicines Agency on ways of ...

12 February 2016

A senior official of the European Medicines Agency is to be an observer on the new French committee set up to look at the preclinical and clinical characteristics of FAAH inhibitors following the death of one volunteer and the hospitalization of ...

11 February 2016

The US Food and Drug Administration's Arthritis Advisory Committee has overwhelmingly endorsed approval of Celltrion Inc.'s biosimilar Inflectra (CT-P13) and has urged the agency to recognize the concept of data extrapolation 1 ,2 . The committee ...

12 February 2016

The World Health Organization has issued draft guidance on what changes relating to IVDs that fall under its prequalification program manufacturers must report to the WHO, what changes do not need reporting, and what changes might require a new ...

12 February 2016

The European Commission is planning to set up a network of experts from the EU member states to work on a set of guidelines on the prudent use of antimicrobials, and will also work internally and with the European Medicines Agency on ways of ...

12 February 2016

A senior official of the European Medicines Agency is to be an observer on the new French committee set up to look at the preclinical and clinical characteristics of FAAH inhibitors following the death of one volunteer and the hospitalization of ...

11 February 2016

The US Food and Drug Administration's Arthritis Advisory Committee has overwhelmingly endorsed approval of Celltrion Inc.'s biosimilar Inflectra (CT-P13) and has urged the agency to recognize the concept of data extrapolation 1 ,2 . The committee ...

05 February 2016

It is well known that biological medicinal products are different from chemically synthesized medicines and that these differences are recognized in terms of the data required to support their evaluation. Regulatory authorities are now ramping up ...

02 February 2016

The European Medicines Agency's pharmacovigilance committee, PRAC, could be ready to start holding public hearings to support the safety review of certain medicines on the market by the second half of this year. The hearings, when in place, will ...

02 February 2016

As part of its efforts to increase the use of biosimilar medicines, the Australian government is setting up a steering group to oversee the implementation of its 'Biosimilar Awareness Initiative', and a new stakeholder group to advise on key issues ...

29 January 2016

As of Feb. 1, marketing authorization holders operating in the EU will no longer have to submit type IA variations to notify the competent authorities of any changes they make relating to their qualified person responsible for pharmacovigilance ...

27 January 2016

The European Commission is examining the supplementary protection certificate (SPC) system for pharmaceuticals to see whether it is still workable, what its failings are, and whether a new EU-wide SPC might be needed in view of the imminent ...

22 January 2016

India has reported progress in discussions with European Union regulators over a ban by the European Commission on hundreds of Indian generic equivalents of off-patent drugs due to testing quality issues. The commission last July told its 28 member ...

18 January 2016

New EU rules on trade marks have come into force as part of a drive to align practices at member state and EU level, make the trade mark system more efficient and easier to use, and reduce the cost of registering marks, especially for smaller ...

 
16 December 2015
Amanda Maxwell
All official meetings between the European Commission, the Council of the EU and the European Parliament to discuss the medical device and IVD regulatory texts have stopped ahead of the end of the Luxembourg Presidency of the Council. There is a ...
 
07 July 2015
Maureen Kenny
Regulators face a difficult balancing act in the debate over how to get innovative medicines to ...
 
12 February 2016
Drug companies should ensure early involvement of their regulatory affairs personnel in EU referral ...
11 February 2016
The number of M&A deals across Asia Pacific is increasing rapidly. But demonstration of product ...
01 February 2016
Mike Snodin discusses the basis of, and possible answers to, some challenging questions on the law ...
 
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