10 09, 2019

EU: Taking Steps to diminish drug shortages

By |2022-10-18T16:18:34+00:00September 10th, 2019|Uncategorized|

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

1 08, 2019

Brexit: Industry should keep Timelines for Batch Testing Facilities

By |2019-08-01T16:13:35+00:00August 1st, 2019|Uncategorized|

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.

31 07, 2019

The meaning of Market Access

By |2019-07-31T09:59:19+00:00July 31st, 2019|Uncategorized|

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

17 07, 2019

Milestone reached by the EU & US (MRA)

By |2022-10-18T16:26:11+00:00July 17th, 2019|Uncategorized|

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

4 06, 2019

Construction begins on WuXi Biologics plant

By |2022-10-25T16:18:30+00:00June 4th, 2019|Uncategorized|

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

1 03, 2019

Brexit: Will UK Inspection Reports and GMP Certificates still be valid?

By |2019-03-01T10:42:34+00:00March 1st, 2019|Uncategorized|

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

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