News Archive

FDA - Platform Technology Designation Program for Drug Development

6th June 2024

Guidance Document available for comment

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FDA - Processes and Practices Applicable to Bioresearch Monitoring Inspections

6th June 2024

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.”

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FDA - Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of BIMO Inspections

6th June 2024

Guidance document open for comment.

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FDA Roundup: 4th June 2024

6th June 2024

An at-a-glance summary of news from around the agency.

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ICH - M12 Guideline reaches Step 4 of the ICH Process

6th June 2024

The ICH M12 Guideline “Drug Interaction Studies” and “Drug Interaction Studies Questions and Answers” reached Step 4 of the ICH Process on 21 May 2024.

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EMA - Horizon scanning on veterinary novel therapies

30th May 2024

The European Medicines Agency has launched a horizon scanning survey on veterinary novel therapies.

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EMA - One Health: How EU agencies are tackling environmental and public health together

23rd May 2024

On 22nd May 2024, the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda in the European Union (EU).

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HMA - Recommendation Paper on Principles of GLP

23rd May 2024

New recommendation paper on principles of Good Laboratory Practices (GLP) for clinical trial applications under the EU Clinical Trials Regulation (Regulation (EU) No 536/2014)

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MHRA - MHRA announces consultation on improved safety for high risk in vitro diagnostic devices

23rd May 2024

Launch of a a four-week consultation which will support improved safety for certain high risk in vitro diagnostic (IVD) devices. IVD devices are used to examine samples taken from the human body and to diagnose and monitor health conditions. For example, devices can determine blood glucose levels and can identify infectious diseases. Accurate performance and trust in the quality of these products are crucial to healthcare professionals considering their use in treating patients.  The new policy we are consulting on would require manufacturers to comply with additional measures for certain high risk IVDs, such as blood tests used to identify blood type before transfusions or tests which identify life-threatening diseases, introducing harmonised requirements for these products. We are also seeking views on the removal of the Coronavirus Test Device Approval (CTDA) process to avoid duplication of regulatory requirements for COVID-19 tests against the Common Specification requirements.   The MHRA intends to incorporate updates to IVD common specifications within a draft Statutory Instrument as part of the future core medical device regulations to be published later in 2024. The updated regulations will then come into force in 2025.     Dr Laura Squire, MedTech Regulatory Reform Lead and Chief Healthcare Quality and Access Officer, MHRA said: We look forward to feedback on our consultation on common specification of IVDs, as we look to strengthen safety requirements around certain classes of crucial diagnostic devices.

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MHRA - proposed framework for international recognition of medical devices

23rd May 2024

MHRA announces a proposed framework for international recognition of medical devices

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