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2006.09.28
Global API Sourcing: What Is Next for Suppliers to the European Union?
Article published in Pharmaceutical Technology Sourcing and Management, July 2006, by Guy Villax and Chris Oldenhof. The authors discuss the preparedness of European regulatory authorities to implement and enforce the recent EU Directives 2004/27 and 2004/28, which require that all medicines marketed in the EU be made with active pharmaceutical ingredients (APIs) that comply with the harmonized GMP standard ICH/Q7A.
2006.09.28
Conference probes EU safety directives
Scrip article CPhI on 1st EFCG Conference. How should pharmaceutical companies conduct their business in the light of new laws for GMP compliance for APIs? A recent conference provided a valuable forum for awareness-raising and discussions.
2006.09.28
GMP moves into the 21st century.
Scrip article CPhI on 1st EFCG Conference. Agencies in Europe and the US are coming round to the idea that they should allow companies to be more involved in ensuring proper manufacturing practice. Nevertheless, Europe has seen a number of major new regulations come in to force over the past year.
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