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Lexology PRO | United Kingdom | 8 Jun 2021
UK delays new public health database
Facing opposition by privacy activists, the UK’s government has postponed the creation of a centralised patient medical information database.
Loyens & Loeff | Netherlands | 6 Oct 2020
Vanaf 1 oktober aanmelden klinisch onderzoek met medische hulpmiddelen bij CCMO
Fabrikanten van medische hulpmiddelen moeten klinisch onderzoek vanaf 1 oktober 2020 aanmelden bij de Centrale Commissie Mensgebonden Onderzoek (CCMO)…
Loyens & Loeff | Netherlands | 6 Oct 2020
Registration of clinical investigations with medical devices with the CCMO as of 1 October 2020
From the 1st of October 2020, manufacturers of medical devices must register clinical investigations with the Dutch Central Committee on Research…
Morgan, Lewis & Bockius LLP | China | 26 Dec 2018
China to Promulgate More Rules to Expedite Approvals for Genetic Resources Administration
The right to privacy in China is generally recognized in the Constitution of the People’s Republic of China and Tort Liability Law. Over the past……
CMS Cameron McKenna Nabarro Olswang LLP | United Kingdom | 20 Dec 2018
Launch of Life Sciences Sector Deal 2
The Industrial Strategy - Life Sciences Sector Deal 2 report is broken down by themes with each identifying what progress has been made by each of the…
Sanchez DeVanny Eseverri SC | Mexico | 12 Dec 2018
Medical investigations: can regulation keep up with technology?
It is well known that the law often struggles to keep up with new products and activities. In many cases, the legal provisions which apply to regulated activities lose their applicability due to the speed with which technology enables parties to operate outside the scope of the law or the jurisdiction of the relevant authorities. This is particularly true for physical research involving......
Duane Morris LLP | Canada, USA, Vietnam | 10 Dec 2018
Vietnam - Healthcare and Medical Devices - Investment - With Outlook on the Major Trade Agreements CPTPP, EUVNFTA and Investment Protection Agreement
A. Overview of the future of Vietnam´s healthcare sector There is no denying that Vietnam truly is an attractive investment destination in South East…
K&L Gates LLP | USA | 16 Oct 2018
FDA Releases Guidance on How Recent Changes to the Common Rule May Impact FDA-Regulated Clinical Trials
On October 12, 2018, the U.S. Food and Drug Administration (“FDA”) released a guidance document titled “Impact of Certain Provisions of the Revised…
Bird & Bird LLP | China | 20 Jul 2018
Life Sciences & Healthcare Newsletter
The China Drug Administration ("CDA") issued the Technical Guidelines and Principles for Accepting Overseas Clinical Trial Data of Drugs ("Overseas…
Dykema Gossett PLLC | USA | 16 Jul 2018
What to Do When Guidance Doesn’t Seem to Guide
On June 14, 2018, the U.S. Department of Health and Human Service’s Office for Civil Rights (OCR) issued guidance to the clinical research community…
