European industry associations seek international co-ordination on cocrystal regulation

Salts and cocrystals can equally be accepted as drug substances

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called on pharmaceutical regulators to dovetail their guidance and controls regarding cocrystals (crystalline structures made up of two or more components in a definite stoichiometric ratio) in medicines.

The EFPIA has welcomed the development of a European Union (EU) reflection paper on cocrystals, arguing that they can be 'considered in the same way as any other drug substance'. The EFPIA added: 'We agree that salts and cocrystals can equally be accepted as drug substances.'

As a result, the EFPIA said international regulatory co-ordination was important regarding the scientific, regulatory and legal aspects of cocrystal use and manufacture. It called for discussions to be staged between the European Medicines Agency (EMA), its Quality Working Party (QWP), and the US Food & Drug Administration (FDA), or International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) regions. These should 'clarify and/or contextualise any significant differences between the regulatory perspectives,' said the EFPIA.

The European Generic medicines Association (EGA) noted raised concern that differences were already emerging. It said the US FDA guidance and the EMA reflection paper 'were developed concomitantly, however not in concentration, and contain divergent approaches to cocrystals.' It stressed: 'This is certainly not a satisfactory situation and we call on EMA to pursue all possible efforts to seek convergence on key scientific, regulatory and legal aspects using existing collaboration platforms (bilateral and/or international such as ICH).'

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