Pharma GMP News of the Week: 26-February-2023
Period: February 19, 2023 to February 25, 2023
EMA published “Questions and answers – Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR)”
Date of news: February 9, 2023
With the purpose of guiding sponsors through the Clinical Trials Regulation (CTR) and the new clinical trials information system (CTIS) portal, the European Medicines Agency (EMA) has released guidance in the form of a question-and-answer document. On January 31, the CTIS had to be used.
The Query Management Working Group (QMWG) of the European Medicines Agency (EMA) created the Q&A in order to address some of the concerns raised by stakeholders, including the Association of Clinical Research Organizations (ACRO), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), and the European Clinical Research Organization Federation (EUCROF).
Source: Questions and answers – Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR)
US FDA Center for Devices and Radiological Health published six final guidelines
Date of news: February 21, 2023