France: ANSM updates Guidelines and Forms for a Scientific Opinion for a Medical Device incorporating a Medicinal Substance

2023-03-29T15:54:00+00:00July 21st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , |

The French National Agency for Medicines and Health Products Safety has updated its Guidance and templates for consultation for medical devices with ancillary medicinal substances. Scientific opinion must be requested for any new medical device or device-drug combination product, [...]

Germany: BfArM and PEI issued supplementary recommendations on management of clinical trials during COVID-19 pandemic

2024-02-26T11:08:52+00:00May 22nd, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: , , , , , |

BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) and PEI (Paul-Ehrlich-Institut) provided supplementary recommendations to the guideline on management of clinical trials during COVID-19 released by the European authorities on 20th March 2020. Key points of BfArM and PEI recommendations on [...]

Germany: DIMDI merges into BfArM

2024-02-26T11:15:21+00:00May 20th, 2020|Categories: Europe, Regulatory, Western Europe|Tags: , , , , , , |

DIMDI (Deutsche Institut für Medizinische Dokumentation und Information) and BfArM (Federal Institute for Drugs and Medical Devices) will join to become one agency on May 26th, 2020. Once DIMDI is merged into BfArM, the name that has been in [...]

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 [...]

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 [...]

IRELAND: HPRA provides recommendations for clinical research management under COVID-19

2024-02-26T12:16:42+00:00March 23rd, 2020|Categories: Europe, Western Europe|Tags: , , , |

Health Product Regulatory Authority (HPRA) recommends some specific measures for the COVID-19 emergency. Meditrial manages several studies in Ireland and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support. [...]

Italy. Covid-19 infection reaches 59.138 with 5.476 deaths. Slowing trends of new cases and deaths recorded today for the first time.

2024-02-26T15:59:57+00:00March 23rd, 2020|Categories: Covid-19, Europe, Western Europe|Tags: , , , , |

A slowdown of the rising trends in the number of Covid infections and deaths was recorded today by the Italian Civil Protection. Healthcare workers infected rise to 4,824 and now their testing is prioritized. The total lockdown in Italy [...]

SWITZERLAND: New Ordinance for Clinical Trials during COVID-19 Emergency

2020-03-21T20:52:48+00:00March 21st, 2020|Categories: Europe, Western Europe|Tags: , , , , , |

UPDATE ON March 21st, 2020 The Swiss federal government published an ordinance to conduct clinical trials during the COVID-19 emergency. This legislation applies to Sponsors, investigators and project leaders of clinical trials and research projects in Switzerland. It is available [...]

FRANCE: ANSM offers practical solution to manage clinical trials amid the crisis

2024-02-26T11:01:22+00:00March 20th, 2020|Categories: Europe, Western Europe|Tags: , , , , |

The ANSM, in conjunction with the DGS and the DGOS, offers practical solutions for implementing the necessary adaptations for clinical trials in progress in the current situation. The solutions proposed by the authorities have been established in order to [...]

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