No. 420 リモート監査

リモート監査の例を教えて下さい。

記事作成日：2020/08/21　最終更新日: 2023/11/29

GMP

水島洋, 寺田宙, 宅本悠希, 山口一郎, 薬事衛生管理研修におけるオンライン査察の経験による，Good Manufacturing Practice（GMP）査察のオンライン化に向けた検討, 保健医療科学, 2022, 71 巻, 4 号, p. 368-372

WHO

FREQUENTLY ASKED QUESTIONS BY THE MANUFACTURING, TRIAL AND TESTING ORGANIZATIONS IN CONNECTION WITH SOME OF THEIR CONSTRAINTS FACED DURING THE COVID-19 OUTBREAK

FDA

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry: Guidance for Industry: APRIL 2021

EU

Regulatory expectations during COVID-19 pandemic

Guidance is available for marketing authorisation holders, manufacturers and importers of human and

veterinary medicines on adaptations to the regulatory framework to address challenges of the COVID-19 pandemic, including with GMP certificates and inspections:

Notice to stakeholders: Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic
Notice to stakeholders: Questions and answers on regulatory expectations for medicinal products for veterinary use during the COVID-19 pandemic
In this context, for sites in the European Economic Area (EEA), GMP certificates and time-limited manufacturing and import authorisations are automatically extended until the end of 2021.

This does not waive manufacturers’ and importers’ obligations to comply with GMP standards.

For new sites and facilities within and outside the EEA that have not been inspected or where an inspection is required, a remote inspection may be carried out. On-site inspections will resume as soon as feasible.

ON LINE service

EudraVigilance

European Medicines Agency

NOTICE TO STAKEHOLDERS

QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC

European Medicines Agency

EMA’s governance during COVID-19 pandemic Share

Table of contents
COVID-19 EMA pandemic Task Force
COVID-19 Task Force
EMA health threats plan
Business continuity plan for the European medicines regulatory network
Working with EU and international partners
Measures to reduce the spread of COVID-19
The European Medicines Agency (EMA) has established dedicated task forces to deal with the scientific, regulatory and operational challenges created by the COVID-19 pandemic and initiated its business continuity plan. The aim of these measures is to safeguard the Agency’s core activities related to the evaluation and supervision of medicines during the pandemic and to ringfence resources dealing with COVID-19.

EMA aims to expedite the development of effective measures to fight and prevent the spread of COVID-19. This includes exploring ways for accelerating the development of COVID-19 vaccines and treatments, in close cooperation with the European medicines regulatory network.

EMA is also working to ensure that the assessment and monitoring of medicines are not disrupted, so that patients in Europe can continue to have access to high quality, safe and effective medicines during the pandemic.

Decision of the Executive Director