k.janecek2024-02-29T13:49:11+00:00May 8th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, UK|Tags: Clinical Trial, Covid-19, Europe, MHRA, Regulatory, UK|
The Medicines and Healthcare products Regulatory Agency (MHRA) updated the guidance for industry on their flexible approaches to regulation during the COVID-19 outbreak. MHRA are working closely with the Department of Health and Social Care (DHSC) and other healthcare [...]
k.janecek2024-02-29T15:19:51+00:00May 8th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, UK|Tags: Clinical Trial, Covid-19, Europe, UK|
The Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on Medical devices clinical investigations during the COVID-19 outbreak. The guidance was first published on March 30th, 2020. In the last update of May 7th, a new section on [...]
adminMTE_04792024-02-29T14:17:04+00:00May 5th, 2020|Categories: Clinical Trial, Covid-19, Europe, Western Europe|Tags: Clinical Trial, Covid-19, Helpline, Spain, Western Europe|
UPDATED ON May 5th, 2020 The Spanish Agency for Medicines and Health Products (AEMPS) provides recommendations for exceptional application during the period of the COVID-19 crisis in Spain. “It is important that the sponsor together with the investigator make [...]
k.janecek2024-02-26T12:08:56+00:00April 29th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: Clinical Trial, Covid-19, Europe, Regulatory|
EMA has endorsed a joint COVID-19 statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) committing to a strengthening of global collaboration in the fight against coronavirus disease. 'The COVID-19 pandemic affects the whole world and the best way to fight it [...]
k.janecek2024-02-02T11:41:53+00:00April 29th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: Clinical Trial, Covid-19, EMA, Europe, European Commission, Regulatory|
European Medicines Agency (EMA) updated the guidance on the management of clinical trials during COVID-19 pandemic. Version 3 published on 28 April 2020 provides additional clarification on: the distribution of medicines to trial participants. This takes into account social-distancing measures [...]
k.janecek2024-02-29T09:43:48+00:00April 28th, 2020|Categories: Clinical Trial, Covid-19, Europe, MDR, Regulatory|Tags: Covid-19, Europe, European Commission, European Union, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for legacy devices; templates for post market clinical follow-up plans and evaluation reports; and regulatory requirements for ventilators. Equivalence [...]
adminMTE_04792024-02-07T16:10:56+00:00April 17th, 2020|Categories: Clinical Trial, Compliance, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, USA|
The FDA has posted a new “At-a-Glance Summary” that captures the agency’s major activities in the fight against COVID-19. The FDA has made a wide range of information regarding their activities available to the public on their COVID19 website. [...]
adminMTE_04792024-02-29T14:26:41+00:00April 16th, 2020|Categories: Clinical Trial, Covid-19, Europe, Switzerland|Tags: Clinical Trial, Covid-19, Europe, Switzerland|
The Swiss Federal Council issues a new regulation allowing marketing of devices that have not undergone a conformity assessment procedure. This will not exempt the manufacturer from proving performance of the device and essential requirement fulfilment. This exception is [...]
adminMTE_04792024-02-29T14:28:12+00:00April 16th, 2020|Categories: Clinical Trial, Covid-19, Europe, Switzerland|Tags: Clinical Trial, Covid-19, Switzerland|
The Swiss Federal Council temporarily suspends custom duties on import medical goods. Such measure was set out to ease the import of medical equipment such as masks, gloves, disinfectant, protective goggles to face COVID-19 emergency in the country. The [...]
k.janecek2024-02-01T16:43:42+00:00April 15th, 2020|Categories: Clinical Trial, Compliance, Covid-19, Regulatory|Tags: Clinical Trial, Columbia, Covid-19, Regulatory|
In accordance with the provisions of Resolution No. 2020012926 of April 3, 2020 "By means of which temporary administrative measures are adopted within the framework of the health emergency declared by the National Government due to COVID-19" , it [...]
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