Tag: MHRA

MHRA Recalled Medicines with Missing Safety Labels

In England, imported medicines have appeared which have apparently been removed or "stolen" from the legal supply chain in order to be reintroduced later into regular sales. With this, both correc...

Pharmaswiss Česka republika Informed MHRA of Emerade Product Failing Risk

Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage ...

MHRA Renewed EAMS Scientific Opinion for Santhera’s Idebenone

Santhera Pharmaceuticals announces that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has renewed for a further year the Early Access to Medicines Scheme (EAMS) scientific opinio...

Pfizer UK Recalled Docetaxel Injection 160mg and Docetaxel Injection 20mg

Pfizer
Pfizer UK Limited is recalling batches as routine stability testing has identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life. CLDA Number...

MHRA Published Serious Breaches of GCP in 2018

The MHRA recently published the 2018 metrics report for GCP serious breaches. Serious breaches of the clinical study protocol or Good Clinical Practice (GCP) have to be reported to the MHRA within ...

EMA to Launch Safety Review of Alemtuzumab

The European Medicines Agency (EMA) has launched a safety review of alemtuzumab following reports of two deaths and several other cases of people experiencing life-threatening reactions shortly after ...

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...