SPAIN: Exceptional measures for clinical trials to manage problems due to COVID-19

2020-05-05T18:29:19+00:00May 5th, 2020|Categories: Clinical Trial, Covid-19, Europe, Western Europe|Tags: , , , , |

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 a [...]

UK: MHRA pragmatic and flexible approach allows special measures for clinical research under COVID-19

2020-04-22T03:40:54+00:00April 22nd, 2020|Categories: Covid-19, UK|Tags: , , , |

UPDATED ON April 22nd, 2020 In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on the management of clinical trials in response to the COVID-19 pandemic. "The MHRA will be as flexible and pragmatic as possible [...]

US FDA Reactions to mitigate pandemic impact on industry and the public

2020-03-31T18:11:28+00:00March 31st, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: , , , |

While global markets are being impacted by COVID-19 pandemic, FDA issues various statements regarding measures to tackle the negative impact on industry and people. Following, we provide a summary of FDA recently introduced regulatory policies. March 31 The FDA has [...]

EMA Guidelines for COVID-19 Impact on Clinical Trial Methodology

2024-02-02T11:39:10+00:00March 26th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: , , , |

The European Medicines Agency (EMA) published a new draft guideline for clinical trials inviting sponsors to evaluate the implications of COVID-19 on methodological aspects of ongoing trials. This guidance covers actions that sponsors of ongoing clinical trials affected by [...]

HUNGARY: Update on measures for clinical studies under COVID-19

2024-02-26T11:39:00+00:00March 25th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

UPDATE ON MARCH 25th, 2020 OGYEI National Institute of Pharmacy and Nutrition updated special measures to face COVID-19 emergency. Updated instructions concern among others: Authorization procedure for new study applications or amendments:  sponsors should submit as "urgent safety measure" [...]

BELGIUM: FAMHP recommends electronic submission during COVID-19 emergency

2024-02-01T16:16:31+00:00March 25th, 2020|Categories: Europe, Western Europe|Tags: , , , , |

UPDATE ON March 25th, 2020 Federal Agency for Medicine and Health Products (FAMHP) recommends some specific measures for the COVID-19 emergency. Meditrial manages several studies in Belgium and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel [...]

DENMARK: Extraordinary Measures for Clinical Trials due to COVID-19

2024-02-02T10:35:12+00:00March 24th, 2020|Categories: Europe, Western Europe|Tags: , , , , , |

UPDATE ON March 24th, 2020 Danish Medicines Agency (Lægemiddelstyrelsen) issued guidance regarding extraordinary measures  and further amendment dated March 24th for clinical trials during a pandemic emergency. The Agency is aware of Covid-19 influence on the conduct of clinical [...]

ROMANIA: Important Announcement of ANMDMR to the attention of companies conducting clinical trials

2020-03-24T10:20:45+00:00March 24th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

UPDATED on March 24th, 2020 National Agency for Medicines and Medical Devices in Romania (ANMDMR) issued an important message to the Sponsors of clinical studies in the country. Announcement from March 13th, 2020 in the local language can be found [...]

LITHUANIA: Lithuanian Bioethics Committee issues guidelines on clinical research under COVID-19

2024-02-26T16:10:55+00:00March 23rd, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

UPDATE ON March 23, 2020 Lithuanian Bioethics Committee issued guidelines on clinical research under COVID-19. However, further guidance is expected to be soon released by the State Medicines Control Agency under the Ministry of Health of the Republic of [...]

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