Om V Singh warns that research and manufacturing outsourcing can lead to a greater risk of patent infringement. Billions of dollars are invested every year in novel drug development with the goal of...
Alan Chalmers reports that progress was made at a conference on the Council of Europe’s proposed MEDICRIME convention, despite the controversy surrounding the World Health Organization’s IMPACT...
Brenda Percy explains why quality should be a part of change management throughout the whole product life-cycle and how to achieve this. Change is often said to be the only constant. This rings true...
Legislation affecting the sector was high on the agenda at the Spanish pharmaceutical industry association’s annual symposium in Madrid. Maria Luisa Bravo reports. The 30th symposium of the Spanish...
Ian Schofield looks at why international efforts are being hindered by the lack of a harmonised approach, controversy over intellectual property issues and the increasing use of the internet as a...
Peter Charlish looks at the regulation of “e-cigarettes” and finds they can be drugs, devices, neither or both. Unless it is very tightly drawn up, any legislation is likely to have unintended...
Linda Surh and David Laurie et al discuss regulatory moves to incorporate pharmacogenomic analysis in the drug development process. Pharmacogenomic (PGx) analysis – the study of how variations in the...
The Food and Drug Administration is pressing on with plans to make electronic reporting of adverse events mandatory. Brenda Percy examines how companies can make a seamless transition from paper to...
Lana Ilić Prelogović , Gorana Perina Lakoš and Marina Krstanović examine the availability of information that generics companies need to develop their products. The development of generic...
There has been an increase in requests from regulatory authorities for unblinded DMC data and reports. Mats Ericson , Shamim Ruff , Alan Morrison , James Matcham and Steve Snapinn examine the issues...
Attilio Sarzi Sartori describes Albania’s simplified procedures as the country aspires to EU membership. Albania submitted its official application for European Union membership earlier this year 1 ....
Maarten Meulenbelt and Helmut Brokelmann explore the practical implications of the long-awaited ruling. On 6 October, the European Court of Justice handed down its long-awaited judgment in the...
Singaporeans are purchasing counterfeit, adulterated and substandard health products over the internet, report Yee Shen Kuan , Ling Boon Lee , Eugene Goh and Jasamine Soh . The internet has evolved...
Tamás Paál describes the country’s new unique regulatory procedure for officially authorising off-label prescriptions. In the European Union, off-label prescribing is not regulated by Community law....
Grant Castle and Brian Kelly describe new enforcement powers that will become available to the Medicines and Healthcare products Regulatory Agency once it complies with the principles of the Hampton...
