How to proceed with an active ingredient that can be effective...
Although numerous clinical trials are underway, there is currently no evidence from controlled clinical trials to recommend...
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Regulatory Affairs
Regulatory Affairs
December 9, 2019
Accessing the European Pharma Market: becoming a MAH through...
Positioned as the second largest pharmaceutical market in the world and showing a steady and extensive growth pattern, Europe’s...
Regulatory Affairs
November 27, 2019
Biotechnology: Incentives of the Advanced Medicinal Products...
What are Advanced Therapies? Advanced-therapy medicines are medicines that are made from genes and cells. They may offer...
Regulatory Affairs
November 27, 2019
Accessing the EU Market: Becoming a suitable CMO for Europe...
In recent years, the volume of generic drug sales has been increasing rapidly in Europe, whereas the outsourcing of branded...
Regulatory Affairs
November 27, 2019
Safety Reports: The importance of high quality content from...
The action plan developed by the AEMPS and published April 2016 focuses on the set up of specific activities, such as the...
Regulatory Affairs
November 21, 2019
Accessing the European Pharma Market: becoming a MAH through...
The European pharma market is becoming more competitive and accessible through its effort to adopt globally acknowledged...
Regulatory Affairs
November 20, 2019
Brexit: Regulatory Impact
On 29 March 2017, the United Kingdom notified the European Council of its intention to withdraw from the European Union,...
