Mhra

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Covid immunization commenced on 2nd Feb 2021 in Pakistan and as of 7th Sep 2021, over 84 million vaccine doses were administered in Pakistan, of which 72% procured by the government, 22% received through Covax and 6% were donated. The vaccines rolled out nationally included: Sinopharm, Sinovac and CanSinoBIO (China), AstraZeneca (UK), Moderna and Pfizer (USA), Sputnik (Russia), and PakVac (China/Pakistan). About half of the eligible population in Pakistan (63 m) had received at least one dose of Covid vaccine as of Sep 2021...

AIM: The Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme (YCS) is the UK's system that collects spontaneous reports about suspected Adverse Drug Reactions (ADRs). Reporting of suspected ADRs by young people (<19y) in the UK is extremely uncommon, driving efforts to improve awareness and reporting. METHODS: Quality improvement project, using an anonymous online survey about updated information for young people, distributed through school pupils (age 13-18) across the UK through the Alder Hey Research Ambassador programme...

OBJECTIVE: The aim was to retrieve and analyse the serious adverse events of venous occlusion systems used in cyanoacrylate adhesive closure (CAC) submitted to regulatory agencies. METHODS: The Total Product Life Cycle (TPLC) database of the US Food and Drug Administration (FDA), the Database of Adverse Event Notifications (DAEN) of the Australian Therapeutic Goods Administration (TGA), and the Yellow Card database of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were reviewed...

Introduction: Accurate and rapid diagnostics paired with effective tracking and tracing systems are key to halting the spread of infectious diseases, limiting the emergence of new variants and to monitor vaccine efficacy. The current gold standard test (RT-qPCR) for COVID-19 is highly accurate and sensitive, but is time-consuming, and requires expensive specialised, lab-based equipment. Methods: Herein, we report on the development of a SARS-CoV-2 (COVID-19) rapid and inexpensive diagnostic platform that relies on a reverse-transcription loop-mediated isothermal amplification (RT-LAMP) assay and a portable smart diagnostic device...

The increase in regulatory challenges on medical technology developed and deployed in the UK is having a negative impact on innovation. In this paper we show how the limited capacity of Approved and Notified Bodies is one more barrier in the innovation pipeline, that could push more teams to consider applying for FDA approval instead of UKCA marking, potentially limiting how much our patients benefit from the world-leading research undertaken in UK universities.

INTRODUCTION: In the United Kingdom (UK), complications that arise following the administration of Botulinum Toxin are reported to the Medicines and Health Regulatory Agency (MHRA) via the Yellow Card Reporting Scheme. Over the past decade, there has been a significant increase in the number of non-surgical aesthetic procedures. Concerns have been raised that the MHRA is not fully capturing complications in terms of volume and impact on patients. AIM: This novel study explores the lived experiences of individuals who have experienced an adverse event following administration of Botulinum Toxin for aesthetic purposes...

INTRODUCTION: Left gastric artery embolisation (LGAE) is a well-established treatment for major upper gastrointestinal (GI) bleeding when control is not established via upper GI endoscopy and recently has shown promising results for weight loss in small single arm studies. LGAE could be a treatment option in between our current tier-3 and tier-4 services for obesity. EMBIO is a National Institute for Health Research funded trial, a multicentre double-blinded randomised controlled trial between Imperial College National Health Service Trust and University College London Hospital, comparing LGAE versus Placebo procedure...

Degenerative eye conditions such as age-related macular degeneration (AMD), diabetic retinopathy, and retinal vein occlusion are major contributors to significant vision loss in developed nations. The primary therapeutic approach for managing complications linked to these diseases involves the intravitreal delivery of anti-vascular endothelial growth factor (VEGF) treatments. Faricimab is a novel, humanised, bispecific antibody that simultaneously binds all VEGF-A isoforms and Angiopoietin-2, which has been approved by regulatory agencies, such as the US Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), for the treatment of neovascular AMD and diabetic macular oedema (DMO)...

Systemic immunoglobulin light chain (AL) amyloidosis is a heterogeneous rare disease driven by a destructive monoclonal gammopathy and typified by misfolded immunoglobulin light and/or heavy chains which aggregate and deposit in organs as insoluble amyloid fibrils. Disease heterogeneity is driven by the degree of multi-systemic involvement; cardiac, renal, neurological, and gastrointestinal (GI) systems are affected to varying degrees in different patients. While prognosis is primarily driven by hematologic response to treatment and outcomes associated with cardiac events and overall survival, the involvement of the peripheral nervous, hepatic, and GI systems can also have a significant impact on patients...

Despite the recognized need for generic drug pharmacovigilance harmonization efforts, only a few studies compared generic drug postmarket safety and surveillance methods adopted by regulatory agencies in different countries. The purpose of this research is to collect available information from a sample of international regulators with the overall goal of providing a general overview of each agency's decision-making processes for postmarket generic drug safety and surveillance. A structured four-part questionnaire of open-ended and multiple-choice questions along with a semi-structured interview were designed to elicit detailed information...

OBJECTIVES: Outbreaks of infection related to flexible endoscopes are well described. However, flexible endoscopy also requires the use of ancillary equipment such as irrigation plugs. These are potential vectors of infection but are infrequently highlighted in the literature. We report a cystoscopy associated outbreak of Pseudomonas aeruginosa from contaminated irrigation plugs, in a UK tertiary care centre. METHODS: Laboratory, clinical, and decontamination unit records were reviewed, and audits of the decontamination unit were performed...

INTRODUCTION: Lacosamide is licensed for the treatment of focal seizures in both adults and children, however there is little information available on its adverse reactions. Using the FDA Adverse Event Reporting System (FAERS), we seek to assess adverse occurrences that may be related to Lacosamide. METHODS: On the basis of the FAERS database from the fourth quarter of 2008 to the second quarter of 2022, disproportionality analysis was carried out using the reporting odds ratio (ROR) method, the United Kingdom Medicines and Healthcare Products Regulatory Agency omnbius standard (MHRA) method, and the bayesian confidence propagation neural network (BCPNN) method...

INTRODUCTION: Perampanel (PER) is a non-competitive AMPA glutamate receptor antagonist used as an anti-seizure medication. Large post-marketing databases are still lacking for safety analysis of the new generation of anti-seizure medications. Based on the FDA's adverse event reporting system (FAERS) database, this study aimed to investigate, assess, and offer evidence for the safety of PER to support clinical decision-making. METHODS: Perampanel-related adverse reaction signals were mined using the reporting odds ratio (ROR), medicines and healthcare products regulatory agency (MHRA), and Bayesian confidence propagation neural network (BCPNN)...

BACKGROUND: The Yellow Card Scheme was created in 1964 to oversee new and existing medicines and medical devices, and act as an early warning system for unexpected adverse drug reactions (ADRs). Under-reporting within the system is a known issue, estimated to be as high as 94% in a 2006 systematic review. Anticoagulants are often prescribed in the UK to prevent stroke in patients with atrial fibrillation but can be associated with gastrointestinal bleeding as a common ADR. AIM: The study aimed to investigate the incidence of suspected DOAC-related GI bleeds at a North-West England hospital and explore the volume of these incidents reported through the MHRA Yellow Card Scheme, over a 5-year period...

INTRODUCTION: The usage of a T-cell depleted, reduced intensity conditioning (RIC) approach to haematopoietic cell transplantation (HCT) in adult patients with acute lymphoblastic leukaemia (ALL) over 40 years of age and in first complete remission (CR) has resulted in encouraging rates of event-free and overall survival in a population of adults with high risk disease. However, relapse rates remain high-with disease progression being the major cause of treatment failure. Using different, more powerful conditioning approaches is the logical next step in examining the role of RIC allogeneic HCT in adult ALL...

Pharmaceutical 3D printing (3DP) has attracted significant interest over the past decade for its ability to produce personalised medicines on demand. However, current quality control (QC) requirements for traditional large-scale pharmaceutical manufacturing are irreconcilable with the production offered by 3DP. The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) have recently published documents supporting the implementation of 3DP for point-of-care (PoC) manufacturing along with regulatory hurdles...

Almost two decades since biosimilars arrived, we still await their broader adoption, as anticipated. The roadblocks to this adoption include the high amortized cost of goods due to regulatory burden, hurdles created by the distribution system, perception of safety and efficacy, and lack of focus by stakeholders on removing these roadblocks. In this paper, I analyze the source of these roadblocks and offer practical solutions to remove them. These efforts are needed to maximize the adoption of biosimilars to encourage the entry of 100+ biological molecules that can bring affordable healthcare direly missing today across the globe...

Project Orbis was initiated in May 2019 by the Oncology Center of Excellence to facilitate faster patient access to innovative cancer therapies by providing a framework for concurrent submissions and review of oncology products among international partners. Since its inception, Australia's Therapeutic Goods Administration (TGA), Canada's Health Canada (HC), Singapore's Health Sciences Authority (HSA), Switzerland's Swissmedic (SMC), Brazil's National Health Surveillance Agency (ANVISA), United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA), and most recently Israel's Ministry of Health (IMoH) Medical Technologies, Health Information, Innovation and Research (MTIIR) Directorate, have joined Project Orbis...

BACKGROUND: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare and life-threatening skin adverse reactions that are usually induced by drugs. This study aimed to assess the association between methotrexate and SJS/TEN when combined with furosemide. RESEARCH DESIGN AND METHODS: Data on suspicious, interactions (PS, SS, I) from the FDA Adverse Event Reporting System database for 2016-2021 were analyzed using the reporting odds ratio (ROR), information component (IC), proportional reporting ratio (PRR) and the Medications and Health Care Products Regulatory Agency (MHRA)...