Regulatory Updates

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UK Consultation on Proposals for Legislative Changes for Clinical Trials

Author: Anna Cesar – Manager, Regulatory Compliance EMEA The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has ran, from January 17 to March 14, a public consultation on 10 issued proposals regarding the regulation of clinical trials in the ...

  • UK Consultation on Proposals for Legislative Changes for Clinical Trials

    Author: Anna Cesar – Manager, Regulatory Compliance EMEA The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has ran, from January 17 to March 14, a public consultation on 10 issued proposals regarding the regulation of clinical trials in the UK. These proposals aim to revise the current Medicines for Human Use (Clinical Trials)… Read more »

  • CDC Noninfectious Certification Statement

    Recently the Centers for Disease Control (CDC) reminded the trade community that shipments of noninfectious diagnostic specimens must be accompanied by a noninfectious certification statement. Providing CDC with a non-infectious certification statement is not a “new” requirement. Title 42 part 71 The Foreign Quarantine regulations state that noninfectious diagnostic specimens may be imported without an… Read more »

  • FDA Launches New 24/7 Drug Entry Review Pilot

    Author: Anna Cesar – Manager, Regulatory Compliance EMEA From March 13, 2022, through June 13, 2022, the Food and Drug Administration’s Office of Regulatory Affairs’ Office of Enforcement and Import Operations (OEIO) will run a new entry review pilot. The pilot has been developed as a way to improve their operational efficiency on account of… Read more »

  • Canada New Client Portal

    AUTHOR: Anna Cesar | Regulatory Compliance Associate The Canada Border Services Agency (CBSA) is modernizing and streamlining the process of importing commercial goods. The CBSA Assessment Revenue Management (CARM) solution will give importers and brokers 24/7 access to border services through the new CBSA Assessment Revenue Management Client Portal (CCP). Canada’s importers and customs brokers… Read more »

  • The New European Medical Device (MDR) and In-Vitro Regulation (IVDR)

    AUTHOR: Anna Cesar | Associate, Regulatory Compliance The transition period for the new European Medical Device (MDR) and In-Vitro Regulation (IVDR) will end soon – May 26, 2021, and May 26, 2022, respectively. If you are an importer of medical devices or IVDs to the EU, you must be prepared for changes. Importer role under… Read more »

  • India: New Mandatory Pre-Arrival Clearance Procedures

    AUTHOR: Reynaldo Roman | Senior Director, Regulatory Compliance India’s Central Board of Indirect Taxes and Customs announces a new rule requiring all air cargo arriving in India to be Customs cleared no later than the day of arrival and preferably before arrival. As of April 1st, importers must ensure that their shipment documents are complete,… Read more »

  • India: New Mandatory Document Requirements

     merchandise for import into the country. On Jan 14th, 2021, India’s Central Board of Indirect Taxes and Customs published Advisory No: 02/2021 announcing a new rule requiring Customs brokers to submit certain documents to Customs when clearing merchandise for import into the country. The new rule requires mandatory uploading of product-specific documents in the e-Sanchit… Read more »

  • New EU Mandatory Export Authorization for COVID 19 Vaccines

    The European Commission announced last week a new, mandatory export authorization requirement for COVID-19 vaccines covered by an Advance Purchase Agreement (APA) with the EU. The new rule applies to vaccines against SARS-related coronaviruses (SARS-CoV species) falling under CN code 3002 20 10 and cover active substances including master and working cell banks used for… Read more »

  • US: Importing COVID-19 Diagnostic Test Kits

    AUTHOR: Reynaldo Roman | Senior Director, Regulatory Compliance COVID-19 diagnostic test kits and other in vitro diagnostic devices (IVDs) are FDA-regulated products that require FDA and Customs and Border Protection (CBP) clearance when imported into the US. The FDA regulates imported medical devices and IVDs. Generally, imported devices must have FDA marketing approval or must… Read more »

  • US: New Export Filing Requirement for Shipments to China, Russia or Venezuela

    AUTHOR: Reynaldo Roman | Senior Director, Regulatory Compliance As of June 29, 2020, exporters of shipments to China, Russia, or Venezuela must comply with a new, mandatory export filing requirement. Any export shipment from the United States to China, Russia, or Venezuela, involving an item classified under an Export Control Classification Number (ECCN), requires an… Read more »

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