EMA: Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19

2024-02-02T11:50:42+00:00May 19th, 2020|Categories: Covid-19, Europe, Regulatory|Tags: , , , |

The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around the world on 14 May 2020 to discuss high-level policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic. The strategic [...]

AUSTRIA: BASG issues information on the withdrawal of measures for clinical trials at the end of the pandemic

2024-02-01T15:08:04+00:00May 19th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: , , , |

The Austrian Federal Office for Safety in Health Care (BASG) updated its FAQ with new information related to the communication with the Federal Office and the withdrawal of measures at the end of the COVID-19 pandemic. Communication with the [...]

EMA updates its governance during COVID-19 pandemic

2024-02-02T11:48:58+00:00May 14th, 2020|Categories: Compliance, Covid-19, Europe, Regulatory|Tags: , , , |

The European Medicines Agency (EMA) updated information on its dedicated task forces to deal with the scientific, regulatory and operational challenges generated by the COVID-19 pandemic and initiated its business continuity plan. The aim of these measures is to [...]

The European Commission answers questions about COVID-19 tracing apps across the EU

2024-02-29T14:36:51+00:00May 14th, 2020|Categories: Compliance, Covid-19, Europe, Software|Tags: , , , |

The European Commission (EC) shared a Q&A on safe and efficient use of mobile tracing apps across the EU. What is a contact tracing and warning app? A contact tracing and warning app is voluntarily installed and used to [...]

MHRA regulatory flexibilities resulting from the COVID-19

2024-02-29T13:49:11+00:00May 8th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, UK|Tags: , , , , , |

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 [...]

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

2024-02-29T14:17:04+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 [...]

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