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China FDA released draft regulations that would require medical representatives in China to register, and mandate that medical product marketing authorization holders provide adequate training. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended seven new products for European Commission approval, including one biosimilar and two orphan medicines, one being an advanced cell therapy. Read More
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency. Read More
The European Medicines Agency’s pharmacovigilance committee revised its methods for measuring the health outcomes of its major regulatory interventions, aiming to improve industry safety monitoring practices and find out which activities have been the most successful. Read More
Between 2015 and 2016, the number of GMP inspections conducted by European Economic Area authorities of non-EU sites dropped by nearly 25 percent, but the authorities reported more findings of non-compliance over the same time period. Read More
Alex Azar, President Trump’s nominee for Secretary of Health and Human Services, emphasized his view that “drug prices are too high” to the Senate Finance Committee, even as Democrats continued to ask about his role in drug cost increases at Eli Lilly when he served as its president. Read More
Australia’s Therapeutic Goods Administration issued revised guidelines for its comparable overseas regulators (CORs) program, designed to collaboratively regulate prescription medicines using an international report-based process. Read More
Testifying before a UK House of Commons committee last month, international pharmaceutical companies said they are already hedging their bets when it comes to the real-world consequences of Brexit, making preparations for new hurdles in manufacturing and duplications of batch release testing that could cost millions of pounds per year. Read More
The European Medicines Agency and the European Commission broadened their guidance on Brexit to include new information for manufacturers of orphan drugs, generics and biosimilars, as well as hybrid medicines that rely on reference product data as well as new clinical trial findings. Read More
The European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines this year, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More
The Patient Engagement Collaborative is gearing up for a launch in early 2018. The new, external panel is being built by the FDA and the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between the FDA and Duke University. Read More
The European Medicines Agency adopted the International Council for Harmonization E7 guideline on multi-region clinical trials, which can support simultaneous product submissions in different parts of the world and more efficient drug development. Read More