Regulators in the European Union (EU) have began taking the first steps reduce shortages of medicinal products. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) recently published two guidance documents. The two guidance documents are said to be used as a foundation. The first guidance document that has
A reminder was sent out to stakeholders of the European Medicines Agency (EMA) which pointed out that, independent from the extension of the date for the UK’s withdrawal from the EU (Brexit) to the 31st of October 2019, Marketing Authorisation Holders (MAH’s) should use the remaining time to complete all necessary preparations.
Market Access is the process to ensure that all appropriate patients who would benefit, get rapid and maintained access to the brand at the right price. Understanding the process: It is important to understand all the processes that impact market access, both internal and external: Payers have processes – at national level
With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories. Each year, EU national authorities and the FDA inspect many
Construction has begun on the €325m WuXi Biologics plant in Dundalk which aims to be the world’s largest single-use biologics manufacturing facility. WuXi Biologics is Chinas leading end-to-end biologics solutions provider with the Dundalk campus and is set to be its first manufacturing facility outside China. The build is on schedule for
The European Medicines Agency (EMA) has updated the agency’s Brexit-related guidance documents. The updated documents support pharmaceutical companies in preparing for the United Kingdom’s (UK) withdrawal from the European Union (EU). All medicinal products that are manufactured or imported into the European Economic Area (EEA) must be follow EU Good Manufacturing Practices