Expectations from TTIP of the Romanian pharmaceutical sector

Focus: generics

  1. Harmonising or bringing closer inspection styles and objectives between the FDA, European Medicines Agency, and national European Agencies.
  1. Mutual recognition of GMP inspections.
  1. Mutual recognition of reference drugs in order to facilitate the approval of generic drugs.
  1. Mutual recognition of the documents forming the file for the marketing authorisation application.
  1. Harmonising as much as possible the two pharmacopoeias: US Pharmacopoeia and European Pharmacopoeia
  1. The GDUFA site fees for each production facility should not be paid before the FDA approval of a generic drug is granted. Instead, it would make more sense to pay the fee for each new application, in addition to covering the inspection cost, and then only pay the GDUFA fee after the approval has been granted.
  1. There should not be an obligation to have an agent/applicant in the US, at least in certain conditions.
  1. The US authorities could make a case by case judgment to set lower GDUFA fees following a needs calculation, in order to allow for alternative treatments and affordable medicine to be widely available on the market.