Industry Seeks Clarity on EU Regulation Governing Changes to MAs

The type of variation submitted and the length of time allowed for a variation to be accepted were chief among the concerns expressed by the industry in comments​ unveiled by the commission on Tuesday.

The regulation deals with the myriad ways that variations to a marketing authorization are classified, which apply to a drug’s manufacturing processes, how active ingredients and quality changes are controlled, and other changes made to either the active substance or finished product’s description and composition, container closure system, stability and design space.

Specifically, the European Federation of Pharmaceutical Industries and Associations (EFPIA) proposes that the guideline allow for the accelerated assessment of variations arising from unforeseen circumstances and where the supply of an essential medicine might be disrupted following standard timelines.

The EFPIA believes the timeframes for such assessments should be set on a case by case basis, following standard variation procedures.

“Overall, we would assert that greater efforts could have been made to introduce more substantial changes to facilitate a ‘more science and risk based approach’ for reviewing post approval changes, where a [marketing authorization holder] has applied an advanced [quality by design] approach to product development, applies quality risk management principles and has implemented a robust Pharmaceutical Quality System​,” EFPIA said.

MedImmune also acknowledged its support for the EFPIA’s fast-track variations and the association’s comments on biologics, which it claims “in most cases, should not be treated differently than traditional pharmaceuticals​.”

And although they are outside of the scope of this revised regulation, the European Generic medicines Association (EGA) took issue with the costs of the variations, noting "high fees for the submission of variations to the MAs should not become a barrier to improving various aspects of medicinal products​."

EGA members also “urgently call on the member states to apply a fees policy which reflects whether real assessment is needed or not, particularly for administrative changes, or the same information already being in the possession of authorities but called differently, whether the same change applies to several products etc. The fees system should better distinguish between individual product related changes and the company’s related changes which apply to several or even all products of the MAH​."

A number of other changes were deemed burdensome and in conflict with changes agreed to with national competent authorities. Ranbaxy, Shire and the Active Pharmaceutical Ingredients Committee were also among the 40 companies, competent authorities and industry groups that commented on the guideline.