A decision is soon expected on a corrigendum initiated in May by the European Commission (EC), to extend the existing transition period for certain class I reusable devices, including some software, that are being up-classified. Read more “Did you know that certain Class I devices could get four extra years to comply with EU MDR?”
A survey initiated by the Regulatory Affairs Professionals Society (RAPS) and the US tax, audit and advisory firm KPMG has established that only 27% of the 230 medical device makers who responded would be fully compliant with the new EU Medical Device Regulations (MDR), coming into effect on May 26th 2020. Read more “73% of medical device makers say they will not be able to meet the full range of compliance criteria for the new EU MDR”
A letter to the European Medicines Agency (EMA) and EU27 Heads of Medicines Agencies (HMA), written by the European Commission’s Directorate-General for Health and Food Safety (Sante), outlines an exemption to certain batch testing requirements for medicine manufacturers who currently perform batching test in the United Kingdom (UK). Read more “European Commission provides update on post-Brexit batch testing requirements”
European Union (EU) member states had until 9th February to implement the final part of the Falsified Medicines Directive (FMD). Member states are required to implement the new falsified medicinal products for the majority of prescription-only medicines, which aims to prevent falsified medicinal products from entering the pharmaceutical supply chain. Read more “Implementing the Falsified Medicines Directive: Safety Features”
A public consultation was launched by the Government in July 2018 regarding actions that need to be taken to ensure that the United Kingdom (UK) meets its obligations to apply the provisions of the Falsified Medicines Directive (FMD). The FMD requires ‘safety features’ to be applied to the packaging of specified medicinal products. The consultation closed on 23rd September 2018, and the final consultation response has been published with the Medicines and Healthcare Products Regulatory Agency’s response to over 50 replies that were received from a variety of stakeholders. Read more “MHRA releases final consultation response for the Falsified Medicines Directive”
The Medicines and Healthcare Products Regulatory Agency (MHRA) has published a GXP data integrity guide. GXP encompasses various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority (GLPMA). These are Good Clinical Practice (GCP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Pharmacovigilance Practice (GPvP). The guidance aims to provide useful information on the core elements of a compliant data governance system across all GXP sectors. Read more “MHRA publishes GXP data integrity guide”
Health Canada has released a risk classification guide that aims to clarify the manufacturing site inspection process for drug manufacturers. The new guidance for good manufacturing practice (GMP) provides information to ensure a uniform approach that inspectors will use to assign one of three different risk classifications to each noncompliance observation noted during inspections of drug manufacturing facilities. The risk classifications are as follows: critical observation (Risk 1), major observation (Risk 2) or other observation (Risk 3). Read more “Health Canada releases risk classification guide for drug GMP observations”
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment, a move that will see increased collaboration in the area of medicine manufacturing site inspections. The FDA will now share full inspection reports that contain non-public and commercially confidential information with the EMA and European Commission.
A clinical evaluation report (CER) is a key supporting document in the steps to obtaining a CE mark. Whilst the initial CER is required at the start of the device lifecycle, many manufacturer’s often don’t appreciate that the report is a ‘live’ document and it must be updated periodically.
The Drug Supply Chain Security Act enacted on November 2013 established a requirement for a Product Identifier to be affixed to each package and homogeneous case of drug introduced into commerce in the USA, from 27th November 2017.