UK MHRA and BSI Statements In Response to Brexit Referendum

Dr. David Lim (Dr. Lim)’s Recommendations to the UK’s Health Authority, Medicines and Healthcare products Regulatory Agency (MHRA) and the BSI To the UK’s MHRA The MHRA should establish its own medical device approval/registration system within the principles of the EU’s medical device regulation or recognize other CE-marked devices available in the EU. Develop a process of recognizing other CE-marked devices Develop

Read more


Conference Report – Pathway of Innovation from Research to Patients

The BioIndustry Association and the Medicines and Healthcare products Regulatory Agency Conference Report Pathway of Innovation from Research to Patients Conference The Wellcome Trust | London | 11 June 2015 There has been an increase in the number of innovative drugs receiving regulatory approvals over the past few years. However, drug development is lengthy, prices are high and there are considerable delays

Read more


UK MHRA Approved the Clinical Trial Application for the New Ebola Vaccine in Four Working Days

UK Approves the Ebola Vaccine Clinical Trial in Just Four Working Days 18 September 2014 Oxford University praised UK’s regulatory authority (MHRA, a centre of the Medicines and Healthcare Products Regulatory Agency) for authorizing the clinical trial application for the new Ebola vaccine in four working days. According to the report, the first healthy UK volunteer has received a candidate Ebola

Read more


Trial Master File (TMF): Good Practices and TMF SOPs

By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn; Google Plus; Twitter The TMF is required for firms who are subject to 2001/20/EC Article 15(5) in EU and should be helpful for those who are subject to 21 CFR Part 312 in the US. What is a Trial Master File (TMF)? A TMF is the collection of documentation that allows the conduct of the clinical

Read more


Patient Safety Alert: Infusion Pumps

Medical Device Alert: Infusion pumps: Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails manufactured by CareFusion (MDA/2013/062) Problems Risk of interruption to therapy. A fault with the front and rear bearings of the pump’s stepper motor may cause the pump to stall during an infusion. The pump stops, alarms and displays a ‘DRV1’ or ‘DRV2’ error on the

Read more


Medical Device Alert | Intraocular Lens | MHRA

By Regulatory Doctor; LinkedIn; Google Plus; Twitter Intraocular lens, one-piece foldable posterior chamber Title Medical Device Alert: Intraocular lens, one-piece foldable posterior chamber manufactured by HOYA Surgical Optics (MDA/2013/021) Summary This Medical Device Alert has been issued due to higher than expected rates of inflammation and/or endophthalmitis observed following implantation of affected intraocular lenses. CAS deadlines Action underway: 9 April 2013, action complete:16

Read more