Indian Drug Exporters Face Formidable New Rules In EU
This article was originally published in PharmAsia News
Executive Summary
Indian drug makers may find it difficult to export their wares to the European Union after Nov. 30. EU law says all drugs and chemical products, foreign and domestic, must be registered by that date with the European Chemicals Agency. The registration rules are extensive and detailed and must be followed or products cannot be allowed in the EU. Pharmaceuticals are estimated to comprise more than 35 percent of the Indian chemicals exported to the EU, yet few companies appear aware of the costly new requirement. (Click here for more
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.