EU trade groups set out proposals to streamline requirements and accelerate approvals of clinical trials with GMO meds

27 September 2017

European pharma/biotech groups today issued their views and aims to support European competitiveness in the biomedical sector, and to avoid unnecessary delays for patient access to such innovative medicines whilst ensuring patient and environmental safety.

The Alliance for Regenerative Medicine (ARM), the European Biopharmaceutical Enterprises (EBE), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and EuropaBio announced the release of their joint position paper, titled “Possible Solutions to Improve European Regulatory Procedures for Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms.”

The paper advances a series of proposals to streamline the application and review processes by the relevant authorities and shorten the time before clinical trials of Advanced Therapy Medicinal Products (ATMPs) that consist of or contain GMOs with such products can be initiated.

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