Generics group calls for say on ICH standards Posted 12/09/2014

The generics industry is somewhat annoyed at being excluded from the decision-making process of a global organization, which harmonizes drug quality, safety and efficacy standards.

The International Generic Pharmaceutical Alliance (IGPA), which represents generics associations from across the globe, sent a letter to the International Conference on Harmonization (ICH) on 8 August 2014 seeking equal status for the generics industry.

The problem stems from an ICH meeting held on 31 May – 5 June 2014, where a recommendation to NOT allow the generics industry a position on the ICH Steering Committee was made clear during a presentation.

Under the proposed structure, the ICH Steering Committee would consist only of regulators and originator industry representatives. To date, the generics industry has participated in ICH meetings, but only in an advisory role.

If this proposed structure goes ahead the IGPA notes that ‘the generic industry will remain completely barred from the formal ICH decision-making process even though the vast majority of ICH guidelines become regulatory requirements and guidances that are directly applicable to generic pharmaceutical manufacturers’.

The ICH has not changed its structure in its more than 20 years of existence, however, during that time the generics industry has changed significantly, with the availability and utilization of generics expanding dramatically globally.

The IGPA points out that ‘the generic[s] industry is now largely a global industry, with generic pharmaceuticals accounting for, on average, over 50% of the prescriptions filled globally. In fact, in 2013, generic pharmaceuticals accounted for over 84% of the prescriptions filled in the US’.  This leads it to argue that the generics industry deserves not only an advisory role, but also a fully recognized seat at the decision-making table.

The IGPA, as a representative of the generics industry, ‘firmly believes it should become equal industry partners in future ICH activities’ and is therefore seeking ‘to join ICH as a full Steering Committee member’.

The IGPA letter concludes with the ‘threat’ that if not included the generics industry would be forced to ‘reconsider participation in the ICH’. The letter states that ‘if IGPA is not included as a Steering Committee member, then we will be required to evaluate our continued relationship with and involvement in ICH.’

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Source: IGPA

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