Tag: MHRA

GDP Inspector Explains Demand in Supplier Qualification

Peter Brown, GDP Inspector at the U.K. Medicines and Health Regulatory Agency MHRA, explains in a Blog what qualification of suppliers means. In the recent GDP inspection history, the MHRA noted se...

British Regulators Issued PIM Designation to MYR

MYR Pharma announced that the British Medicines and Healthcare products Regulatory Agency (MHRA) has issued the Promising Innovative Medicine (PIM) designation for MYR's lead compound Bulevirtide (Myr...

MHRA Recalls Drugs for Heart Diseases

The Medicines and Healthcare Products Regulatory Agency (MHRA) recalled 3 batches of Irbesartan.  The recall is taking place as part of the continued investigation into potential N nitrosodiethylam...

SID&GP about MoU and Relatioship with UK

On January 29, the UK and Russia have signed a memorandum of understanding enhancing cooperation in the field of regulation of medicines. Radio Sputnik discussed the development with Nikolay Tsatsy...

UK and Russia’s Medicines Regulators Signed MoU

Medicines regulators of the UK and Russian set out key principles to support their collaboration on improving public health. The Medicines and Healthcare products Regulatory Agency (MHRA) has signe...

No-Deal Brexit – Guidance for Clinical Trials

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) released further guidance on the regulation of medicines, medical devices and clinical trials if there is no Brexit deal. The scenar...

Redx to Restart Cancer Drug Trial

Redx has secured approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to restart a phase 1/2a trial for its cancer candidate RXC004 in advanced solid tumors. An oral po...

Orphan Designation for Silence’s β-Thalassemia Drug

Silence Therapeutics’ lead candidate SLN124 has secured orphan drug designation in the European Union for the treatment of β-Thalassemia. The designation to SLN124 was granted by the Committee for ...

MHRA Approved Upperton New Facilities

Spray drying specialist has invested in building enhancements and in the expansion of its processing and analytical capabilities The UK Medicines and Healthcare products Regulatory Agency (MHRA) ha...

Men in UK Sentenced for Illegal Supply of Meds

Three people have been handed custodial sentences in England for their involvement in the illegal supply of potentially dangerous prescription-only medicines. Jagdiep Dhonsi, Amrin Mirza and Shirin...

Risk for Pharma after Brexit still Unknown

A ‘no deal’ Brexit will change and burden how all industries that move materials and goods across borders, including the pharmaceutical and medical device sectors, do business. Pharmaceutical compa...

UK MHRA clarified cross-contamination Control Requirements

With the introduction of the Permitted Daily Exposure (PDE) values in conjunction with questions on cross contamination and on cleaning validation, the EMA began a new chapter a few years ago. This is...