The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has stepped back from its requirement that generic products based on a different salt or ester form of the active pharmaceutical ingredient of a drug must undergo a full product review.
The MHRA's strict adherence to this requirement has meant that all generic manufacturers must provide their APIs in the same form as the branded product, or miss out on a shortened route to approval with a reduced commitment for preclinical and clinical testing.
Now, new European Union (EU) legislation means that from 31 October different salt, ester and other modified forms of an API may be considered for approval as generics on the back of abridged application dossiers.
The new Annex to Directive 2001/83/EC specifies the additional data to besubmitted where the new product is a different salt, ester etc and states when such an association is to be considered a new active substance.
The MHRA said that it is changing its practice to comply with the EU legislation, and will accept abridged dossiers for these applications, as long as the sponsor company can provide data to demonstrate that there is no change in the pharmacokinetics, pharmacodynamics or in toxicity which would change the drug's safety/efficacy profile.
However, it points out that there is no formal guidance on the nature of these data, so for now each application will be assessed on a case-by-case basis.