Citeline Engage: Supporting clinical trial pl...

Clinical Trial Information System (CTIS)

14 Sep 2021

Created by the European Medicines Agency (EMA). Stakeholders will use CTIS to: Submit and approve clinical trial applications (CTAs), Submit trial reports, results and notifications, Communicate centrally with the Member States Concerned (MSC) in the clinical trial

Topic Policy & Regulation Clinical Trials Clinical Trials Blog

Generics Bulletin: ジェネリック＆バイオシミラーニュース

EU Reforms Must Heed Pandemic Lessons

By David Wallace 29 Nov 2020

Reforms set out by the European Commission to better prepare the EU for future health crises must heed key lessons learned from experiences of the COVID-19 pandemic, such as the benefits of digitalization, Medicines for Europe has urged.

Topic Coronavirus EU Policy & Regulation

Medtech Insight: 世界の医療機器・医療技術の最新情報

10 Predictions On How Health Policy Could Change Under A Biden Presidency

By Sue Darcey 29 Nov 2020

Health policy changes that President-elect Joe Biden will likely make during his four-year term include Medicaid expansion and a greater reliance on medical science, among others, experts say.

Topic US Election 2020 Leadership Policy & Regulation

Topic brexit policy-and-regulation

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Health Sector On High Alert As Wuhan Coronavirus Spreads

27 Nov 2020

The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, the Chinese government maintains that the situation is “preventable and controllable.”

Topic China infectious-diseases policy-and-regulation Coronavirus

Medtech Insight: 世界の医療機器・医療技術の最新情報

FDA ‘Stands Ready’ To Fight Coronavirus Via Emergency-Use Test Kits While WHO Mulls Virus Spread, Gets Out Guidance

By Sue Darcey 27 Nov 2020

The US Food and Drug Administration (FDA) stands poised to proceed with hastened approvals for 2019-coronavirus (nCoV) diagnostics, treatments and vaccines, if a public health emergency is declared, after an infected US traveler who caught the disease in Wuhan, China returned from the province to Washington State. Spread of the disease has reached a crisis level in China, and the World Health Organization met on 22 and 23 January to consider what actions to take to contain the virus, while issuing an interim laboratory test guidance for use in diagnosing the disease.

Topic drug-approval clinical-trials Coronavirus policy-and-regulation

Medtech Insight: 世界の医療機器・医療技術の最新情報

Diagnostics Industry In Spotlight As Germany Doubles Down To Prevent Second COVID-19 Wave

27 Nov 2020

Germany’s authorities are back on guard against COVID-19 following renewed regional outbreaks. Diagnostics manufacturers will continue to play a strong part in bringing the pandemic substantially under control, a recent industry association virtual conference heard.

Topic Coronavirus policy-and-regulation

Medtech Insight: 世界の医療機器・医療技術の最新情報

Diagnostics Development For Coronavirus Begins As Second US Patient Tests Positive

By Sue Darcey 27 Nov 2020

Bioresearchers at the Centers for Disease Control and Prevention are hoping that diagnostic platforms previously used to develop tests for outbreaks of other epidemic respiratory diseases, including SARS and MERS, can be built on to develop new diagnostics to detect more cases in the current coronavirus outbreak, US infectious disease authorities say. This comes as more patients are monitored around the US for the disease, and a Chicago woman returning from China tests positive.

Topic drug-approval clinical-trials Coronavirus policy-and-regulation