Guest User
EU Commission Releases Draft Annex 11: ...

12/02/2025

-

On July 7, 2025, the European Union (EU) Commission and Pharmaceutical Inspection Co-operation Scheme (PIC/S) published an updated draft of Annex 11: Computerised Systems, a supplementary guideline that is part of the Good Manufacturing Practice (GMP). Although it is GMP focused, the guiding principles of the annex can also be applied to other GxP standards.

EU Commission Releases Draft Annex 11: Computerised Systems
Guest User
Warning Letter Issued to Investigator of ...

11/18/2025

-

In July, 2025, the US Food and Drug Administration (FDA) issued a warning letter to an investigator conducting a clinical trial for pediatric participants. The warning letter was the result of a routine inspection part of the FDA’s Bioresearch Monitoring Program (BIMO) as well as the investigator’s written response to the Form FDA 483.

Warning Letter Issued to Investigator of Pediatric Study
Guest User
ISO Release DIS 9001:2026 for Quality ...

11/06/2025

-

On August 27, 2025, the International Organization for Standardization (ISO) released a Draft International Standard (DIS) for the ISO 9001:2026 Quality Management Systems (QMS) to ISO member bodies for a twelve-week review and ballot period. The goal of ISO 9001 is to help organizations create and maintain consistency of their products or services and seeks to improve and refine their internal processes and procedures to increase efficiency.

ISO Release DIS 9001:2026 for Quality Management Systems
Guest User
Problems Found in Sponsor-Investigator Led Trial

10/30/2025

-

On March 25, 2025 the U.S. Food and Drug Administration (FDA) issued a warning letter to the sponsor-investigator of a study due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection. The sponsor-investigator’s written response to the FDA Form 483 were deemed inadequate therefore the FDA issued a warning letter stating that the sponsor-investigator was noncompliant with multiple regulations within 21 CFR part 312.

Problems Found in Sponsor-Investigator Led Trial
Guest User
Sponsor BIMO Warning Letter – What is a Drug?

10/08/2025

-

On April 30th, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter and Form FDA 483 to the sponsor of a clinical investigation as the result of a Bioresearch Monitoring Program (BIMO) inspection. 40 participants were enrolled in the study and took the investigational product that the sponsor claims was to help individuals with sleeping disorders without submitting an Investigational New Drug (IND) application.

Sponsor BIMO Warning Letter – What is a Drug?

UK

MHRA Updates EHR Remote Access Monitoring Guidance

9/21/2021

-

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) updated their guidance document, “Access to Electronic Health Records (EHR) by Sponsor representatives in clinical trials” in September 2021. Originally released in November 2020, it did not provide adequate guidance on direct remote access of EHR. Other relevant guidance only included small sections on remote monitoring, including the March 2020 guidance describing best practices for managing clinical trials during the COVID-19 pandemic and the November 2020 guidance describing how to minimize disruptions in the conduction and integrity of clinical trials amid the ongoing pandemic.

Draft GDPR Adequacy Decision for UK

3/02/2021

-

When the Brexit transition period ended at the end of 2020, the United Kingdom (UK) officially left the European Union (EU) single market and customs union. This means that for the purposes of the General Data Protection Regulation (Regulation (EU) 2016/679 or GDPR), the UK is a third country with regards to data transfer. As a third country, personal data transfers require additional safeguards. At the beginning of 2021, the EU-UK Trade and Cooperation Agreement came into effect. A part of this Agreement includes a provision which allows data transfers to continue without additional mechanisms until an adequacy decision is adopted, for a maximum of six months.

How Does Brexit With No Withdrawal Agreement Affect Clinical Trials?

2/26/2019

-

The United Kingdom (UK) notified the European Union (EU) of its intent to withdraw effective March 30, 2019, a process commonly known as Brexit. At that point, it will become a “third country” and will not follow the EU regulations for pharmaceuticals. Negotiations are underway for a withdrawal agreement. The European Medicines Agency (EMA) and the European Commission have released guidance related to pharmaceutical companies’ distribution of drugs due to the uncertainty of authorization of a withdrawal agreement.