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Posts with tag regulatory

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Singapore Gets Vaccinated! Introduction of the Pandemic Special Access Route (PSAR) for COVID-19 vaccines, therapeutic products and medical devices
As part of a slew of measures to mitigate the effect of the COVID-19 pandemic in Singapore, the Health Sciences Authority (HSA) recently rolled out the Pandemic Special Access Route (PSAR) to facilitate early access to critical health products needed for the treatment and/or prevention of infectious diseases like COVID-19. Eligible health products may be granted interim authorisation for manufacture, import and supply in Singapore even before registration, while continuous evaluation...
March 25, 2021
6 min read
Introduction of the Narcotic Drugs Amendment (Medicinal...
On the 3rd February 2021, the Narcotic Drugs Amendment (Medicinal...
March 2, 2021
1 min read
Impact of Brexit on Artificial Intelligence in Hea...
AI developments in the UK The UK is starting...
February 5, 2021
5 min read
Hungary: New Legal Provisions set out Mandatory Infrastructure...
Until recently the Hungarian legal background of telemedicine...
September 29, 2020
4 min read
Post-Transition Brexit: New MHRA Guidelines on Medical Devices
With a post-transition Brexit looming on the horizon, the Medicines and Healthcare products Regulatory...
September 21, 2020
4 min read
Transfer of value in France: publication of the regulatory provisions specifying the ceilings above which an authorization from the authorities is required
An important change to the new regime governing transfer of value to HCPs, students and associations...
August 20, 2020
2 min read
COVID-19: Our series of regulatory legislation trackers for the Life Sciences & Healthcare industry
COVID-19 presents an unprecedented challenge to the global life sciences industry.  Members...
July 30, 2020
1 min read
Transfer of value in France: the long-awaited “anti-gift” decree has finally been published
The French so-called “anti-gift” provisions strictly frame the conditions under which companies in the...
June 19, 2020
2 min read
COVID-19: Our series of regulatory legislation trackers for the Life Sciences & Healthcare industry
COVID-19 presents an unprecedented challenge to the global life sciences industry.  Members...
May 7, 2020
1 min read
COVID-19: The NIPN’s Regulatory and Data Protection Guidance on adjustments in clinical trials
On the tails of the EMA’s Guidance on the Management of Clinical Trials during the COVID-19 pandemic,...
April 27, 2020
8 min read
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