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 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.
Data Integrity deviations are still in the focus of regulators. Nevertheless you will find only general requirements regarding Data Integrity in the GMP Guidelines. More detailed guidelines on Data Integrity are on the way but mostly available as drafts. Get an overview on the current situation and the first implementation steps of Data Integrity activities.
There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP). Read more about the revisions of several GVP Modules and the published draft of Product- or Population-Specific Considerations IV: Paediatric population.
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.
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.
The European Medicines Agency (EMA) has updated its Q&A section on the Mutual Recognition Agreement. These questions mainly refer to the start of the operating phase of the MRA on 1 November 2017.
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.
Raman is a technique often used for incoming API and excipients inspection besides IR and NIR. New suggestions for updating the chapter were published in the USP's Pharmacopeial Forum. Find more information on USP chapter <858> Raman Spectroscopy.
The ICH E11 Addendum reached Step 4 of the ICH Process and now enters into the implementation period. Read more about ICH E11 Clinical Investigation of Medicinal Products in the Pediatric Population.