News Archive

FDA - In September 2024, the U.S. FDA issued a Warning Letter to the Indian company MMC Healthcare Ltd.

17th October 2024

Inspected March 2024

Read More+

EMA - Veterinary Scientific Guidance Update

4th October 2024

EMA adopted and draft guidance

Read More+

VICH - Veterinary Scientific Guidance Update

4th October 2024

New Guidance

Read More+

FDA - Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

2nd October 2024

This guidance provides information for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs.

Read More+

MHRA - webinar on Implementing the new UK Clinical Trials regulations

30th September 2024

Registration now open.

Read More+

MHRA - Drug Safety Update Newsletter

27th September 2024

September 2024

Read More+

World Health Organization - 2024 Guidance for Best Practices in Clinical Trials

26th September 2024

The World Health Organisation (WHO) has developed some guidance on best practices for clinical trials was developed following extensive global input, including public consultations.

Read More+

MHRA - An update on our plans for Med Tech regulatory change

25th September 2024

New Blog Post

Read More+

MHRA - AI Airlock pilot call for applications

24th September 2024

Apply now to join the AI Airlock pilot by the MHRA. Benefit from industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.

Read More+

MHRA - Wholesalers and manufacturers guidance following agreement of the Windsor Framework

13th September 2024

Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework

Read More+