Starting in January, all active pharmaceutical ingredients (APIs) shipped into the EU must meet good manufacturing practice standards, and by July, they'll also need documented certification from their countries of origin.
As FiercePharmaManufacturing reports, the new regulations are designed to prevent substandard APIs from creeping into the European market, especially from India and China, which account for about 80% of bulk APIs in the world.
However, some worry that scaling up regulatory hurdles will slow down the importation process, potentially leading to shortages. Furthermore, as in-Pharma Technologist notes, it's possible that many of the world's largest API CMOs will balk at the new requirements and focus on other markets instead.
For its part, India has said it plans to help companies meet the requirements by designating a government office to issue the certifications, but if that process becomes too onerous, individual manufacturers are likely to do what makes them the most money, and that may not include doing business with the EU.
- here's FiercePharmaManufacturing's report
- get more from in-PharmaTechnologist