News Archive

EMA - Overview of comments on on ICH guideline Q9 (R1) on quality risk management

4th May 2022

EMA have provided an overview of comments received between December 2021 and March 2022 on on ICH guideline Q9 (R1) on quality risk management.

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MHRA - Compliance Monitor (CM) Overview and Application Process

4th May 2022

From April 2022, the MHRA will be running a pilot scheme to monitor companies that fail to comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and are referred to the Inspection Action Group (IAG) after an inspection that has resulted in the compliance escalation process being initiated.

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022

19th April 2022

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022

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FDA - Request for Comments.- Cybersecurity in Medical Devices

19th April 2022

FDA Request for Comments - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

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FDA/ICH - E8(R1) General Considerations for Clinical Studies

19th April 2022

FDA/ICH - E8(R1) General Considerations for Clinical Studies.

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EMA - Public Consultation on the Approach of Protection of Personal data

13th April 2022

The European Medicines Agency has published for public consultation a draft guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS).

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