The United Kingdom’s (UK’s) Medicines and Healthcare products Regulatory Agency (MHRA) have added a new section to their “no-deal Brexit” guidance for medical devices, regarding the “UK Responsible Person”. Read more “MHRA update their no-deal Brexit Guidance for medical devices.”
Year: 2019
What is KASA and how will it affect you? FDA explains plans for the new pharmaceutical quality assessment system.
The US Food and Drug Administration (FDA) has been developing a new pharmaceutical quality assessment system known as the Knowledge-aided Assessment & Structured Application (KASA). Read more “What is KASA and how will it affect you? FDA explains plans for the new pharmaceutical quality assessment system.”
EMA to provide new guidance on avoiding nitrosamine impurities in human medicines.
After various animal studies were conducted, nitrosamines have been classified as “probable human carcinogens”. Read more “EMA to provide new guidance on avoiding nitrosamine impurities in human medicines.”
Did you know that the EMA and the US FDA are aligned in more than 90% of marketing authorisation decisions for new medicines?
One of the findings of a joint European Medicines Agency (EMA) and Food and Drug Administration (FDA) analysis compared decisions on 107 new medicine applications at the two agencies for the period 2014 to 2016. The majority of the information used for the study was sourced from EMA’s publicly available European Public Assessment Reports (EPARs) and FDA reviews. Read more “Did you know that the EMA and the US FDA are aligned in more than 90% of marketing authorisation decisions for new medicines?”
How will the MHRA regulate biological medicines including biosimilars, ATMPs and PMFs in the event of a no-deal Brexit?
The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their guidance which outlines the procedures that the MHRA plan to introduce to regulate biological medicines in the event of a no-deal Brexit. The guidance covers United Kingdom (UK) marketing authorisation for biosimilars, marketing authorisation applications for advanced therapy medicinal products (ATMPs) and plasma master files (PMF) post Brexit. Read more “How will the MHRA regulate biological medicines including biosimilars, ATMPs and PMFs in the event of a no-deal Brexit?”
MHRA updates guidance on substantial amendments to a clinical trial if there is a no-deal Brexit
The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their no-deal Brexit guidance which covers significant amendments to a clinical trial. This includes changes to the trial sponsor/legal representative, investigational medicinal product (IMP) certification and importation and amendments to the Research Ethics Committee (REC). Read more “MHRA updates guidance on substantial amendments to a clinical trial if there is a no-deal Brexit”
MHRA provides update on pharmacovigilance system requirements if there is a no-deal Brexit
The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their guidance on the qualified person responsible for pharmacovigilance (QPPV) including the pharmacovigilance system master files (PSMF) in a no-deal Brexit. Read more “MHRA provides update on pharmacovigilance system requirements if there is a no-deal Brexit”
FDA finalises guidance on designing nonclinical studies and product labelling for radiopharmaceuticals used in oncology
The United States (US) Food and Drug Administration (FDA) have finalised their guidance on designing nonclinical studies and product labelling for radiopharmaceuticals used in oncology. Read more “FDA finalises guidance on designing nonclinical studies and product labelling for radiopharmaceuticals used in oncology”
British Pharmacopoeia and the United States Pharmacopeia formalise partnership to strengthen the quality of medicines and public health
The British Pharmacopoeia (BP) and United States Pharmacopeia (USP) have signed a memorandum of understanding which formalises their partnership to strengthen quality standards for medicines. Read more “British Pharmacopoeia and the United States Pharmacopeia formalise partnership to strengthen the quality of medicines and public health”
MHRA updates clinical investigations of medical devices guidance in line with the EU MDR
The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) have updated their 2013 medical device clinical investigation guidance in line with the European Union’s (EU) medical device regulation (MDR). Read more “MHRA updates clinical investigations of medical devices guidance in line with the EU MDR”