Australia: Updated Clinical Trial Handbook

On March 15, Australia’s Therapeutic Goods Administration (TGA) published a revised version of their Clinical Trial Handbook[i]. The updated handbook provides guidance on the legal framework for conducting clinical trials of unapproved therapeutic products in...

Argentina: Procedural Changes to the 9-point Form Submission

As of February 1, 2018, Argentina’s Ministry of Health (ANMAT) is only accepting the 9-point inspection information required for the export of biologic specimens via the TAD electronic system. Paper versions of the 9-point inspection previously used by the agency will...

Marken Addresses Volgograd Airport Acceptance of Dangerous Goods

Please note that the Volgograd Airport in Russia has halted the acceptance of Dangerous Goods materials effective immediately.  While this development will affect couriers who rely on this airport for transport of their DG shipments as a waypoint through Russia,...

Argentina’s New Rules for Import and Export of Biologic Specimens

Until recently, companies in Argentina were required only to list the relevant clinical study protocol number when importing or exporting biologic specimens. Now, as of July 1, 2017, importers and exporters must obtain specific approval from Argentina’s ministry of...