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Regulatory Updates Blog

African Swine Fever Outbreak in Belgium to Affect Laboratory Goods Shipped to Australia in Logistics Blog

The confirmation of an African Swine Fever (ASF) outbreak in Belgium — and its potential threat to the European market — caused Australian authorities to make changes on import regulations for pig meat and commodities such as laboratory goods containing or potentially contaminated with pig material (porcine). Read more...

Plastic and Thermo Cool Products Made from Plastic Banned in India in Logistics Blog

The Environment Department of the Government of Maharashtra has issued a ban on plastic products, as of June 23, 2018, under "Notification No.Plastic-2018/C.R. No.24/TC-4." Maharashtra is India's second-largest state with a population of more than 100 million. Read more...

Change for Importing Medical Devices Into Chile — New Documentation Required in Logistics Blog

Effective July 02, 2018, the import of medical devices into Chile will require a new document from the ISP (Instituto Salud Publica-Public Health Institute.) The document, named CDA, can be processed online from the ISP platform, and when approved, will visible to both the importer (CRO/CRA and local laboratories) and the customs office. Read more...

New Regulations Affecting Clinical Trials in Peru in Logistics Blog

On June 30, 2017, Peru's Ministry of Health (MINSA) issued a new regulation that will reinstate clinical studies for the pediatric population and native communities. Read more...

Airline Laptop Ban Likely to Expand to Europe in Logistics Blog

There is an ongoing uncertainty regarding the expansion of the in-flight electronics (laptops, tablets, etc.) ban to Europe. Currently, the U.S. Department of Homeland Security official position is that the expansion is being considered but no decision has been made. Read more...

Argentina to Shorten the Clinical Trials Approval Timelines in Logistics Blog

On April 26th, The Ministry of Health in Argentina (ANMAT) has issued a new regulation that shortens the timelines for the approval of clinical trials from 160 business days to 70 days (60 days for review and 10 days for administration paperwork). Read more...

Mexico City Official Name Requires Modification to Forms in Logistics Blog

Effective February 1, 2017, Mexico’s capital name will officially be Mexico City or Ciudad de Mexico (CDMX). Read more...

Regulatory Update: New CFDI Export Regulations in Mexico in Logistics Blog

Mexico's Tax Authority (SAT) has confirmed that the CFDI (electronic invoice process) will be mandatory for the export of patient samples from Mexico effective March 1, 2017. The following process will be required: Read more...

Highlights of the 2017 Phacilitate Cell & Gene Therapy World Conference in Miami, Florida in Logistics Blog

With more and more gene and cell therapies approaching final stages of the clinical trials, the industry is nearing its historic breakthrough point - to provide people around the world with access to revolutionary treatments that save, extend and improve lives. 

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REGULATORY UPDATE: Clarification on New CFDI Export Regulations in Mexico in Logistics Blog

Mexico’s Tax Authority (SAT) has decided to revisit their stance on whether the export of patient specimens will require the use of the electronic invoice system. They are now considering March 1, 2017 as the implementation date for the electronic invoice process if they decide to move forward with its application to patient samples. Read more...