LATEST NEWS UPDATE

FDA Current Activities Update...

The FDA has just published a presentation on their current activities. The presentation shows how changes in FDA regulations could...

EMA's Campaign against Counterfeit Medicines...

There has been a development in the EMA’s on going campaign against counterfeit medicines. The EMA have released for public consultation: Draft Template for the written confirmation for active substances imported into the European Union for medicinal products for human use.  This document can b...

Draft Guidance on Process Validation...

The EMA have just released a new Draft Guidance on Process Validation. The guideline is aligned with ICH Q8, Q9 and Q10 documents and adds the possibility to use Continuous Process Verification in addition to, or instead of, traditional Process Verification described in the previous guideline. You ...