by Richard Staines
LONDON, Jan 22 (APM) - Pharma representatives on Thursday gave broadly positive feedback about a new cost-saving initiative to promote global generic filings, but warned the scheme could fail without adequate co-operation between regulators.
The European Generic Medicines Association (EGA) regulatory and scientific conference in London heard Teva is among the first companies to sign up for the International Generic Drug Regulators Pilot (IGDRP).
Earlier this week, the European regulator called for more companies to register their interest in IGDRP, which aims to co-ordinate global filings of generics (APMMA 41156).
In the first phase of the process, the EU will share regulatory data with Australia, Canada, Chinese Taipei and Switzerland with a further 10 applications for generics to be chosen. The aim of the scheme is to reduce the cost of filings and to promote faster access to generics.
Peter Bachmann, chair of the Co-ordination Group for Mutual Recognition and Decentralised Procedures (Human), said that lack of resources had meant the project had been slow to get off the ground, but added it would take time to implement as some regulators were co-operating for the first time.
“It is about building up trust in other countries. It is a learning process,” said Bachmann, representing national regulators.
Adrian Andrews, hospital regulatory affairs manager at Teva Europe, said the firm had already signed up to a pilot of the system last year.
He said it has become immediately apparent the scheme would work best for large international generics firms with affiliates in the countries involved.
Regulators involved were enthusiastic and supportive, said Andrews, who gave no details about which product was involved in the global filing.
But he said the initiative will only succeed if the regulatory process is co-ordinated across different regulators, so that information could be sent to Europe’s decentralised process and shared efficiently with the other regulators.
If any of the other regulators were lagging behind, this could cause delays and lead to duplication of work, said Andrews.
“If timelines start to slip what you will see is additional duplication of work within regulators. For industry the whole thing will potentially fall apart and industry will not be as willing to take part.”
Andrews added that the scheme could lead to use of a single reference product for global filings, using bridging data to prove bioequivalence when the same product is filed in multiple countries.
A similar system is beginning to operate in the field of biosimilars, where the U.S. and EU regulators can share filing data if bioequivalence is proven using a bridging study.
“If you are to produce bridging data to show a reference product is the same in Switzerland than why not push that towards the higher goal. We should be able to use one reference product for all data,” said Andrews.
Gary Clapp, vice president of regulatory affairs EMEA at Mylan, agreed. He said: “If there is acceptance that we could use a reference product outside the EU…that is something that will want to save costs and resources."
The approach would only be possible if the different regulators agreed on a common set of standards for bioequivalence.
He said: “In bioequivalence there is a lot of divergence across different countries. We need to look at what the effects of having different study requirements for what is essentially the same product.”
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