Regulatory Updates

The Latest

AVOID CLINICAL TRIAL DISRUPTION IN SOUTH AFRICA

MARKEN UTILIZES GLOBAL NETWORK TO REACH PATIENTS THROUGHOUT THE WORLD During this critical time, while countries like South Africa are extremely limited with transport options, Marken utilizes our global network to safely transport biological sample shipments out of the ...

  • AVOID CLINICAL TRIAL DISRUPTION IN SOUTH AFRICA

    MARKEN UTILIZES GLOBAL NETWORK TO REACH PATIENTS THROUGHOUT THE WORLD During this critical time, while countries like South Africa are extremely limited with transport options, Marken utilizes our global network to safely transport biological sample shipments out of the country and ship clinical drug products to sites and patients. Our fully operational status ensures we… Read more »

  • US Importation of PPE

    AUTHOR: Reynaldo Roman | Director, Regulatory Compliance In an effort to facilitate the import and supply of PPE into the US, both Customs (CBP) and the FDA have provided guidance on the types of PPE that may be imported. To combat PPE shortages, the FDA has invoked its Emergency Use Authorization (EUA) authority to lift… Read more »

  • Coronavirus COVID-19 and Dangerous Goods handling / Transportation F.A.Q.

    AUTHOR: Nora Pasinetti Sauter In the light of the rapidly evolving situation of COVID 19 epidemic and recent reports from the WHO (World Health Organization), US CDC (Center for Diseases Control & Prevention), ECDC (European Center for Diseases Prevention & Control), Marken has developed the following FAQ.   What is the Dangerous Goods Classification for… Read more »

  • China: CFDA New Drug Import License Procedure

    AUTHOR: Reynaldo Roman China Food and Drug Administration’s new import licensing procedure requires importers to apply for their CFDA import license online. In an ongoing effort to modernize trade, China Food and Drug Administration (CFDA) announced that as of December 27, 2019, importers must apply for their drug import licenses via the China International Trade… Read more »

  • U.S. Federal Government Shutdown

    In the wake of the U.S. federal government shutdown, life science companies question how it may affect their critical shipments of clinical supplies and biological lab samples. Currently, Marken is not experiencing any significant delays in processing import or export entries at U.S. ports. Besides customs, our primary concern relates to the services provided by… Read more »

  • Australia: Imports of Placebos and Clinical Trial Kits Now Duty Free

    As of July 1, 2018, imports into Australia of clinical trial kits containing placebos or a combination of medicines and placebos are duty-free. A recent update to the Australian Customs Tariff introduced new “Free” rate of duty provisions for clinical trial kits and placebos under Schedule 4, item 56. The kits and placebos covered under the new… Read more »

  • US: Proposed Tariff Rate to Impact Clinical Supplies Imported from China

    The Office of the U.S. Trade Representative (USTR) published a list of products that are subject to the proposed tariff increase on goods imported from China[i]. The targeted tariff will impose an additional 25% tariff rate on approximately 1,300 products from China. Included in the list of products affected by the 25% tariff increase are… Read more »

  • 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 Australia. While the handbook does not describe all of the requirements for conducting clinical trials, it is a valuable resource… Read more »

  • 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 no longer be accepted. The 9-point inspection information is used to capture export shipment… Read more »

  • 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, Marken is NOT affected as our teams already have alternative means in place to route… Read more »

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