EMA consults on new guidance for manufacturing process declarations
Document on the manufacture of the finished dosage form has not been revised since 1996
The European Union (EU) pharma sector has been asked for its views on the potential revision of a key document used in marketing authorisations – the manufacture of the finished dosage form.
This has not been changed since 1996 and as manufacturing processes have changed significantly in 17 years the European Medicines Agency (EMA) wants to see how much the form and associated guidance should be changed.
‘With new manufacturing practices and more complex manufacturing chains, a need to incorporate holding times and conditions as well as shipping transportation conditions has been identified and will be discussed,’ EMA said.
It said that current guidance does not fully reflect recent developments and changes both in legislation and associated guidelines and it ‘should be brought up to recent manufacturing practices and should allow different approaches to [the] manufacture of the finished dosage form’.
This would ‘increase flexibility for industry,’ the agency added.
The deadline for comments is 31 December.