Australia’s Therapeutic Goods Administration has issued an update on its overhaul of the regulatory framework for complementary medicines — also known as ‘traditional’ or ‘alternative’ medicines including vitamins, minerals, herbal, aromatherapy and homeopathic products. With these reforms the TGA aims … Continue reading
I never expected a dog show to be the inspiration for my next post, but nevertheless, that is exactly what has happened. When I switched on the TV recently, I was presented with Daisy the medical detection dog (MDD), a … Continue reading
The Italian Medicines Agency, AIFA, is enhancing its scientific and regulatory activities by establishing six new advisory committees covering major therapeutic areas. The committees will contribute to the work of the agency’s technical scientific commission (CTS) and its pricing and … Continue reading
The UK complementary medicines sector could take a hit from critics such as The Nightingale Collaboration following recent cases involving product contamination and misleading advertising. Contaminated Chinese medicines The UK medicines regulator, the MHRA, has issued a warning about several … Continue reading
The inclusion of patients in drug development and regulatory decision making has been steadily increasing over the past several years. Various initiatives have come from a range of stakeholders including regulators, pharma companies and academia. This has been a progressive … Continue reading
Three new papers published by the Global Medical Technology Alliance highlight how the industry’s challenges are different to those facing the pharmaceutical industry. HTA Position Paper: explains why applying health technology assessment to medical devices is difficult and why adopting a … Continue reading
Europe’s Innovative Medicines Initiative Joint Undertaking (IMI JU) recently announced that it intends to set aside up to €8 million to fund a three-year public-private research project on incorporating real-life clinical data into drug development. In a webinar on 2nd August, … Continue reading
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is working to improve the speed and efficiency of its review systems. One way it is doing this is via its new Science Board, which met for the first time on 18th June … Continue reading
Well, it’s final: The Anti-Counterfeiting Trade Agreement, ACTA, has been rejected by the European Parliament in a 478-39 vote (with 165 abstentions). A statement by Parliament said: “While debating [on] whether to give its consent to ACTA, Parliament experienced unprecedented … Continue reading
The European Parliament’s vote on proposed legislation for a unitary EU patent system that was due to take place on 4 July has been postponed at the 11th hour after the European Council concluded that three key articles (6-8) should be deleted … Continue reading
