FDA has issued setting temporary rules on a probable cancer-causing impurity formerly regulated. To avoid market shortage of Losartan, drugmakers will be able to make losartan with an impurity percentage above its prescribed level for six months while the supply of clean drugs is ramped up. A calculated risk, to preserve blood pressure drugs availability […]
Blockchain is an increasingly widespread technology that is approaching a stage of maturity that could see an explosion of its use also in the health sector. The point of the situation has been published in “Blockchain in Healthcare Today (BHTY)”, which identifies the ten main trends of this evolution. Consolidation of startups and user education […]
Yes it is! Recently the U.S. Food and Drug Administration (FDA) has determined that there is credible evidence to support a qualified health claim that consuming oleic acid in edible oils, such as olive oil, sunflower oil, or canola oil, may reduce the risk of coronary heart disease. For this reason FDA decided to exercise […]
European Medicines Agency (EMA), has published its draft of ‘Regulatory Science to 2025’ strategy for a six-month public consultation, following the workshop organized last October. This “Reflection Paper” is a proposed plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. The strategy will […]
With a value of 122.6 billion dollars in 2017, which in 2022 will reach a figure of 145 and 175 billion dollars, the Chinese pharmaceutical market was the second largest in the world, after the US. A huge development that has not gone unnoticed by Alibaba, the Chinese colossus of e-commerce, who last June after […]
Pharmaceutical and MD companies now have a brand new channel for their inbound marketing activities on the Italian market. In fact, after the new Advertising Guidelines issued by Italian Ministry of Health, Facebook decided to open their platform to Pharma OTC and OTC-MD adv campaigns: a huge B2C market is about to be at reach […]
Published today in the Official Bulletin of the State, the legislative decree number 101/2018 aligns Italy to the GDPR rules that have been released on May 25th. The decree will be active from September 19, 2018 and aims to bring a step forward for the transparency in the relations between patients and health service; as […]
PQE Group is proud to announce that the draft of the new Russian Guide for Industrial Data Integrity has been published on the website of GILS – Russian State Institute of Drugs and Good Practices. After the collaboration with COFEPRIS, the Mexican Regulatory Authority, for the creation of the data integrity chapter of the NOM […]
On Wednesday 27th of June has been presented at the 3rd PDA Europe Annual Meeting in Berlin a white paper about the issue of the Audit Trails Review. The ongoing theme of the European Annual Meeting is Global Healthcare of the Present & the Future, as it intends to continue spanning a bridge between current […]
Amsterdam – At the end of the line, Netherlands’ capitol city won with a ‘coin toss’ the EMA assignment over Milan at the very final rush, with just 502 votes for, 112 against and 37 abstained from the European Parliament session. It has been a tough race though, conditioned by the big delays encountered by […]