MHRA

News MHRA

• Successful MHRA Inspection of Almac’s Clinical Services UK Facility

  Almac announced the successful inspection of its Clinical Services operations located in Craigavon by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The inspection, which occurred from 17th to 20th September 2012, was a routine inspection conducted by a MHRA inspector from the re more

• Oxford BioMedica Announces Successful MHRA Inspection for its Proprietary Manufacturing Facility

  Oxford BioMedica plc  announces that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture bulk drug material for Investigational Medicinal Products (IMPs) at the Company’s specialist manufacturing facility in Cowley, Oxford.  This represents more

• MHRA Issues GMP Certification to AMRI UK Facility

  AMRI announced that the Medicines and Healthcare Regulatory Agency (MHRA) of the UK government has issued a Good Manufacturing Practice (GMP) certificate for AMRI's manufacturing facility in Holywell, Wales, UK, following an inspection in October 2011. The MHRA inspection follows a U.S. Food and Dru more

Publications MHRA

• Effects of MHRA drug safety advice on time trends in prescribing volume and indices of clinical toxicity for quinine

  Summary Aims To ascertain the effects of the Medicines and Healthcare products Regulatory Agency's (MHRA) safety update in June 2010 on the volume of prescribing of quinine and on indices of quinine toxicity. Methods We analysed quarterly primary care total and quinine prescribing data more

• The Role of Systematic Reviews in Pharmacovigilance Planning and Clinical Trials Authorisation Application: Example from the SLEEPS Trial

  by Carrol Gamble, Andrew Wolf, Ian Sinha, Catherine Spowart, Paula Williamson Background Adequate sedation is crucial to the management of children requiring assisted ventilation on Paediatric Intensive Care Units (PICU). The evidence-base of randomised controlled trials (RCTs) in this area is sm more

• Dissemination and uptake of a new treatment pathway for paracetamol poisoning in the UK: a survey of healthcare professionals

  Summary Aims On 3 September 2012, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) notified healthcare professionals of immediate changes to the intravenous acetylcysteine license terms, altering the treatment pathway for paracetamol poisoning. We sought to evaluate awareness more

Market studies MHRA

• Gene Therapy Market to 2018 - Product Development Slowed by Clinical Failures, Close Regulatory Surveillance and High Compliance Standards

  GBI Research’s new report, “Gene Therapy Market to 2018 - Product Development Slowed by Clinical Failures, Close Regulatory Surveillance and High Compliance Standards”, provides in-depth analysis of the unmet needs, drivers and barriers that impact the global gene therapy market. The report analyzes more

• United Kingdom Pharmaceuticals and Healthcare Report Q2 2012

  BMI View: While the strength of the UK’s pharmaceutical manufacturing industry is significant, the sector will face considerable challenges over the coming years. Economic weakness, patent expirations and cost-containment with regard to public sector spending will negatively affect the country’s att more

• Stem Cell Technologies: World Market Outlook 2011-2021

  How will the stem cells market develop this decade? Our new report shows you that emerging industry and market's revenue potential from 2011 to 2021. This report covers stem cells in therapeutic applications: technologies, products and services. You will assess events, opportunities and activities more

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