Brazil issues reminder on import licensing:
This article was originally published in Clinica
Executive Summary
The Brazilian health surveillance agency, Anvisa, has issued a reminder that all imported healthcare products for use in research and clinical trials must receive an import licence before they leave the country of origin. The regulations, set out in Article 62 of Resolution RDC-01 of January 6 2003, seek to ensure that the handling and storage of such products is subject to the quality control criteria of the manufacturer.
You may also be interested in...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.