The growth of drug development and outsourced clinical work is causing regulatory affairs officials at pharma and biotech firms to increase their workload more than ever before, according to a new study by the Tufts Center for the Study of Drug ...

The World Health Organization has endorsed the Pan African Clinical Trials Registry as the primary trials registry in Africa 1 ,2 . The PACTR, which was officially launched at the African Vaccine Regulatory Forum in Nigeria on 25 September 3 , is ...

Pfizer says it is close to agreeing on a settlement with Nigeria to resolve a lawsuit that alleges that the company?s Nigerian clinical trial of its meningitis drug, Trovan (trovafloxacin mesylate), in 1996 was unethical and led to the death or ...

An Australian Senate committee has called off its inquiry into a major medicines pricing bill in view of the hung Parliament that has resulted from the federal elections 1 ,2 . The Community Affairs Legislation Committee was due to submit its final ...

India's department of industrial policy and promotion (DIPP) has put out a "discussion paper" on the controversial subject of compulsory licences, aimed at developing a "predictable environment" for the use of such measures in the area of medicines ...

Dr Richard Barker, the director general of the Association of the British Pharmaceutical Industry , says the National Institute for Health and Clinical Excellence should not set drug prices as part of the coalition government's planned value-based ...

The Department of Health in England and Wales has said it will look at the price rises of a "small number" of generic medicines 1 . "We are aware that the prices of a small number of medicines have risen in recent times and we are reviewing what ...

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 patenting drugs, but research and manufacturing ...

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 conduit for counterfeit medicines. With medicines ...

The South African Medicines Control Council has extended until the end of October an initiative aimed at tackling the backlog of applications that has built up over the past few years. The project began on 1 July and had been scheduled to finish on ...

Please give details of the major acts and directives governing trademarks Law No 9279/96 of 14 May 1996, the Industrial Property Act, regulates procedures and obligations relating to trademarks, patents, industrial designs and geographic indications ...

The growth of drug development and outsourced clinical work is causing regulatory affairs officials at pharma and biotech firms to increase their workload more than ever before, according to a new study by the Tufts Center for the Study of Drug ...

A post-inspection letter from the US Food and Drug Administration raising concerns about a pharmaceutical company?s facilities may be unwelcome, but it could also be seen as an opportunity, according to one expert. Though form FDA 483 letters ...