EFCG authorises Generic Drug User Fees Act
Will lead to more predictable regulatory review times
The European Fine Chemicals Group (EFCG), the representative body for European manufacturers of fine chemicals, has agreed to authorise the proposal of the US Food and Drug Administration (FDA) to put forward a legislative package, designed with the help of EFCG and US industry representatives, to deliver into US law a new Generic Drug User Fees Act (GDUFA).
GDUFA requires the FDA to commit to significantly improve and enhance its regulatory activities for the benefit of global generic drug providers and US generic drug users, in exchange for the global generics industry providing the FDA with US$299m in user fees each year over the next five years.
The key benefits for drug providers will be faster and more predictable regulatory review times, including dealing with the backlog of applications, and parity of inspections between domestic and foreign sites for both finished dosage form (FDF) and active pharmaceutical ingredient (API) manufacturers.
EFCG board member and Hovione chief executive Guy Villax said the outcome of the negotiations are ‘epoch-making for our industry’ and, if adopted, will go a long way to deliver on EFCG’s major objective to level the playing field for its members.
He added: ‘Regulators’ weak enforcement has made non-compliance a major competitive advantage. We congratulate FDA for leading the way to find solutions that both protect the patient and stop unfair competition.’