Regulatory Updates
The Latest
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 Dec...
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15/01/2020
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 »
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17/01/2019
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 »
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09/07/2018
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 »
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04/04/2018
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 »
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26/03/2018
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 »
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13/02/2018
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 »
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11/01/2018
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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14/12/2017
Shipments of patient kits and biological specimens are facing Ministry of Health clearance delays caused by technical problems with the ANVISA GRU/GVS web portal. Importers and exporters in Brazil are required to process their ANVISA sanitary surveillance inspection fees (GRU/GVS) through an ANVISA web portal so that they or their agent (e.g., Marken) can pay… Read more »
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21/07/2017
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 health, ANMAT, for shipments of biologic specimens. According to ANMAT notification No. 0004[i], companies involved in… Read more »
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24/02/2017
The Mexican Treasury Department (SAT)’s most recent technical update on CFDI reporting has caused confusion among exporters of non-commercial samples. According to SAT’s notice[i], new functionality will go into effect on March 1, 2017 that will allow for CFDI reporting of both commercial and non-commercial export shipments. This announcement comes as a surprise to Mexican… Read more »
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