A Supreme Court judge set to hear a case involving a challenge by Novartis against Section 3d, a controversial provision in India's patent law, has recused himself ? a move that is now expected to require a new judge to hear the case at a later date ...
The Tanzanian Food and Drugs Authority has issued two complementary draft guidelines to further the implementation of its new medtech regulatory framework 1 ,2 . The first draft document describes the agency's processes and procedures for issuing ...
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 ...
Australia's Therapeutic Goods Administration has published a consolidated guidance under its new biologicals framework, which came into force on 31 May and has a three-year transition period 1 ,2 . The consolidated guidance, called the Australian ...
A new guidance on developing human cells for clinical applications is available 1 . The guidance was issued by the British Standards Institution , which says the document was written with an EU/US audience in mind and anticipates that it will be ...
The Danish Medicines Agency has issued a list clarifying which clinical trial amendments will require approval by the DMA and which modifications can merely be notified to the agency 1 ,2 . The list has been issued in response to questions on the ...
The Global Harmonization Task Force has published a consolidated list of the definitions commonly used in its final guidance documents 1 . The list consolidates the various definitions published in guidance documents written by different study ...
In a drive to expand its global reach, the International Conference on Harmonisation has for the first time nominated non-ICH regulators to serve in its quality, safety and efficacy expert working groups; specifically, technical experts from China, ...
Brazil's R&D-based industry association, Interfarma, has welcomed a controversial legal decision to restrict the powers of medicines regulator Anvisa in the granting of patents. Nevertheless, it says the move does not go far enough. Meanwhile, civil ...
The promise of a system of device and in vitro diagnostics regulation is still very much alive in South Africa, even if the timelines remain sketchy. South Africa has a growing medtech market ? 95% supplied by imports ? but it has never had a ...
The US Food and Drug Administration has expressed concern over the protracted negotiations it is having with the medtech industry over reauthorising its medical device user fee programme, minutes from a 2 August meeting between the FDA and industry ...
