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Focus on Regulation

Tag Archives: consultation paper

EMA launches public consultation on the use of patient disease registries for regulator purposes

Introduction On 5 November 2018, the EMA published a discussion paper concerning the use of patient disease registries for regulator purposes. The discussion paper was published within the context of the EMA’s Patient Registries Initiative (PRI). The consultation period is open to stakeholders until 29 June 2019. It has been published to allow stakeholders to

The Government sets out its proposals for judicial review reform

Following David Cameron’s announcement to the CBI on 19 November, as described on this blog, that the Government would reform the judicial review process, the Ministry of Justice has now published a consultation paper with its proposals for reform (the “Proposals“). Under the existing system, the Government argues, only a small proportion of applications (one