News Archive

FDA - Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities

25th October 2023

Today, FDA issued a draft guidance to inform industry about the agency’s continued use of remote interactive evaluations as an approach for evaluating drug facilities, as appropriate.

Read More+

MHRA and international partners publish five guiding principles for machine learning-enabled medical devices

24th October 2023

The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have collaborated to identify five guiding principles for the development of predetermined change control plans (PCCPs). These guiding principles for PCCPs aim to remove the regulatory burden for developers of machine-learning-enabled medical devices (MLMDs), enabling reallocation of resources to improve product performance for patients.

Read More+

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 October 2023

13th October 2023

EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its October 2023 meeting.

Read More+

MHRA - New streamlined notification scheme for lowest-risk clinical trials marks start of MHRA overhaul of regulation

12th October 2023

The scheme will see the lowest-risk clinical trials processed by the MHRA in less than 14 days.

Read More+

EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 October 2023

6th October 2023

A summary of the most recent EMA Committee for Veterinary Medicinal Products (CVMP) meeting.

Read More+

EMA - Revised transparency rules for the EU Clinical Trials Information System (CTIS)

6th October 2023

EMA has adopted PDF icon revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System. The simplifications introduced will give access to clinical trial information to stakeholders including patients and healthcare professionals in a faster and more efficient way.

Read More+

EMA Management Board: highlights of October 2023 meeting

6th October 2023

EMA Management Board: highlights of October 2023 meeting

Read More+

EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP)

20th September 2023

Held 5-7 September 2023

Read More+

EMA - Accelerating clinical trials in the European Union (ACT EU) initiative website

20th September 2023

EMA is pleased to inform you that a website has been launched for the Accelerating clinical trials in the European Union (ACT EU) initiative, co-led by the European Commission, the Heads of Medicines Agencies and the European Medicines Agency.

Read More+

EMA - CTIS newsflash

20th September 2023

15 September 2023

Read More+