In an effort to keep up with the advances being made in manufacturing technologies, the European Commission (EC) is updating its 2007 technical guidance on good manufacturing practices for sterile drugs.
As biopharma and med-tech companies grapple with restrictive data privacy laws in the EU and China while trying to meet the demand for greater diversity reflective of the U.S. population, there’s been more of an interest in conducting clinical trials in the U.S., Stacy Amin, a partner at Morrison & Foerster LLP, told BioWorld.
Medtech Europe, the European trade association for the medical technology industry covering diagnostics, medical devices and digital health, released its latest survey. This study analyses the availability of medical devices in 2022 in light of the Medical Devices Regulation (MDR) being implemented.
Implementation of the new regulations for medical devices and in vitro diagnostics in the EU have presented a number of problems, including a serious crunch in the availability of notified bodies (NBs) to review premarket filings.
As biopharma and med-tech companies grapple with restrictive data privacy laws in the EU and China while trying to meet the demand for greater diversity reflective of the U.S. population, there’s been more of an interest in conducting clinical trials in the U.S., Stacy Amin, a partner at Morrison & Foerster LLP, told BioWorld.
The European Commission launched a new research initiative with $10 million from Horizon Europe, the E.U.’s research and innovation program, to create a cutting-edge decision-making tool to help clinicians and patients select the best lung cancer treatment based on each patient’s specific needs and circumstances. The I3Lung initiative brings together 16 international partners from Germany, Belgium, Denmark, Italy Sweden, Switzerland, the U.S. and Israel.
Turkey needs to provide a level playing field for foreign and domestic drug producers. That’s the recommendation of three World Trade Organization (WTO) arbitrators in a dispute resolution between Turkey and the EU.
Providing faster and better access to new medicines is the driving force behind a two-year proof-of-concept pilot program the EMA plans to launch in September.
In an era of ever-increasing change in regulation of medical devices, the 2021 draft regulatory proposal by the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) might have seemed like an invitation to regulatory balkanization. However, MHRA said the responses to the draft proposal indicated widespread support for “international collaboration with like-minded regulators,” thus reassuring industry that their developmental devices won’t face an entirely new set of barriers to access to a market of more than 67 million.
