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When Britain leaves the EU, the European Medicines Agency (EMA) will have to move as well. The final decision where to was made by drawing the name of the new EMA location out of a hat. How could that happen?
In line with the go-live date of the new EudraVigilance database EMA now published the revised GVP module IX on signal management. The revised module IX will introduce major procedural changes for industry.
In June, the FDA reported that the enforcement of requirements for the safety of supply chains will be postponed by a year. The new date is now November 27, 2018. Find out more about the change of the date in the FD&C Act.
The FDA has recently published various guidelines on application procedures for generics. Read here, which special requirements have to be met for the authorisation application of generics for the US market.
Insufficiently planned and performed media fills were at the centre of an FDA Warning Letter. Read more about the criticised deficiencies from a Warning Letter to the Korean manufacturer Firson Co., Ltd.