The global market for orphan drugs was worth almost $85 billion in 2009. Furthermore, the market is predicted to grow at a compound annual rate of around 6% over the next few years, which is at least...
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...
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...
India's drug regulatory agency, the Central Drugs Standard Control Organization (CDSCO), has issued for consultation draft guidance on requirements for gaining marketing approval of fixed dose...
Research-based drug industry association Medicines Australia has written to a senate committee urging that the Parliament should pass before 1 October a medicines pricing deal bill that aims to save...
Indian pharmaceutical firms are protesting against what they claim are attempts by multinational companies to influence and tweak critical aspects of India's intellectual property rights (IPR)...
The not-for-profit Society for Clinical Data Management (SCDM) has published a Japanese translation of its Good Clinical Data Management Practices (GCDMP) resource, giving clinical data managers in...
The Indian drug regulatory agency, the Central Drugs Standard Control Organization, has done away with a provision that allowed manufacturers of biological drugs to obtain default clearance of...
The Australian Competition and Consumer Commission (ACCC) is inviting feedback on its proposal to authorise for three years, subject to certain conditions, a new code of practice for the country's...
Leading contract research organisations say that deaths reported during clinical trials in India still account for just about 1% of the patients participating in these studies, despite the seemingly...
The Thai government has decided to extend the compulsory licensing period for two HIV drugs, Merck & Co's Stocrin (efavirenz) and Abbott Laboratories' Kaletra (lopinavir plus ritonavir), to the end...
The Australian Senate has extended until 2 September the reporting time for its inquiry into the how the granting of gene patents is impacting the healthcare system 1 . The inquiry, by the Senate's...
New Zealand's regulatory agency Medsafe is planning to deliver an updated version of its Uniform Recall Procedure for Medicines and Medical Devices (known as the Recall Code) by the end of September...
Cough and cold medicines in New Zealand that contain dextromethorphan and phenylephrine will from 1 May 2011 no longer be sold in supermarkets for children under 12 years of age and will instead be...
China and Taiwan have signed a wide-ranging bilateral agreement on the protection of intellectual property rights, which lays down major principles with implications for many products, including...
