Regulatory Updates

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...

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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...

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Mexico’s CFDI Export Reporting Update and New Deadline

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...

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2017 Global Harmonized System Update

Recent updates to the U.S. Harmonized Tariff Schedule (HTS) result in new HTS classifications for pharmaceutical products.  The 2017 updates to the HTS, which went into effect on January 1, 2017, revamped several chapters and headings of the HS by deleting, adding or...

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