EMA says more comprehensive tests of topical products are needed
Owing to concerns about the reliability of current assessments
The European Medicines Agency (EMA) wants to amend guidance on the development of topical medicines because of concerns about the reliability of current assessments.
'It has become evident that their quality needs to be thoroughly understood and characterised, supported by a robust manufacturing process and control strategy,' said an EMA consultation paper.
The paper added that the designated shelf life for such medicines needs to be based not only on physical, chemical and microbiological stability, but also, when necessary, 'on evidence of stable in vitro performance to assure equivalence throughout storage'.
Generalised assessments of topical products are difficult because the effectiveness of their application can vary. But the EMA says it is possible using 'appropriate comparative quality data with the relevant reference medicinal product, including qualitative and quantitative composition, microstructure, physical properties, product performance and administration'.
This data must be representative, the test methods appropriate and validated, and equivalence acceptance criteria adequate, said the EMA. The proof that such methods could support a claim of therapeutic equivalence needs to be developed 'taking account of the site of action of the active substance(s)'. The advantages and disadvantages of each method also need to be considered.
