Global Regulatory

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Global Regulatory

ACRO engages regulators around the world on behalf of its members. Whether the issue is new guidance from the FDA, a reworking of the Clinical Trials Directive in Europe, or emerging regulation of CROs in India and China, ACRO works to support fair and consistent regulations that promote clinical research while protecting the safety of research participants.   

Some of the specific issues we are following now include:Revision of the Clinical Trials Directive (Directive 2001/20/EC):

Formal Comments to the European Commission concerning the “Draft Revision 3 of Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial." (Link to PDF)

Formal comments to the European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health (Link to PDF)

ACRO Comments on EU Clinical Trials Directive (Link to PDF )