LATEST NEWS

Roche and the ABPI: What Does it Mean for Self-Regulation?

Friday 3 July 2009

Roche's decision not to rejoin the UK industry body the ABPI after its six-month suspension for breaching the advertising code of practice has understandably made waves in the sector.

Other Top Stories

European Commission updates its borderline products manualEuropean Commission updates its borderline products manual

Friday 3 July 2009
The European Commission has published an updated version of its manual on the classification of borderline products that contains opinions on new products.

Australian reform proposals progress through parliamentAustralian reform proposals progress through parliament

Thursday 2 July 2009
Legislation aimed at improving and clarifying the regulation of therapeutic goods in Australia, including medicines, is progressing through parliament.

International clamour over Germany's seizure of Indian generics shipmentInternational clamour over Germany's seizure of Indian generics shipment

Wednesday 1 July 2009
Another seizure of an Indian-manufactured generic drug by a customs authority in the European Union has fuelled concern that the EU’s enforcement of intellectual property rights regulations is delaying access to essential medicines in developing countries.

More News >>

   

 

LATEST ANALYSIS

Roche and the ABPI: What Does it Mean for Self-Regulation?

Friday 3 July 2009
Roche's decision not to rejoin the UK industry body the ABPI after its six-month suspension for breaching the advertising code of practice has understandably made waves in the sector.

The Changing Face of Pharmacovigilance and the EU Risk Management PlanThe Changing Face of Pharmacovigilance and the EU Risk Management Plan

Thursday 2 July 2009
EMEA official Jan Petracek explains planned changes to pharmacovigilance activities in the EU and the implications for biosimilars. Faraz Kermani reports.

Strategies for Dispute Resolution with the US Food and Drug AdministrationStrategies for Dispute Resolution with the US Food and Drug Administration

Thursday 2 July 2009
The dispute resolution process may take months to years; however, if a sponsor has a compelling data-based argument, and the tenacity to endure a long process, the outcome can be successful, say Margaret and Andrew Uprichard.

Driving Business Compliance with IT ProcessesDriving Business Compliance with IT Processes

Thursday 2 July 2009
Erik Vollebregt and Mathias Klümper describe a process-oriented and IT-driven business compliance approach that can help pharmaceutical companies avoid contravening fraud and abuse rules in the European Union and the US.

More Analysis >>

freetrial

COMMENTS

No Let Up in the Debate over Exclusivity Terms for Biosimilars in the US

Tuesday 30 June 2009
Ian Schofield reports on White House backing for seven years of data exclusivity.

More Comments >>


REFERENCE

Download the latest recently updated and newly issued regulatory guidelines and legislation here for free.

July 2009 guidelines


More References >>

PEOPLE

New health ministers appointed at DoH in England

Wednesday 1 July 2009
Gillian Merron has been appointed public health minister at the Department of Health in England, with responsibility among other things for relations with the pharmaceutical industry and the Medicines and Healthcare products Regulatory Agency.

Helliwell appointed NICE vice chair

Wednesday 1 July 2009
Margaret Helliwell has been appointed vice chair of the UK National Institute for Health and Clinical Excellence.

More People >>