The Chinese State Food and Drug Administration’s (SFDA) new GMP regulations could result in a restructure of the country’s drug industry. In March 2011, the SFDA announced new GMP regulations, which firms must adhere to by December 2015. Chinese drug exports conform to European, US and Japanese regulations, so Chinese firms that export active pharmaceutical ingredients (APIs) are unlikely to be impacted. But drugs sold within China are not subject to the same standards, and thus the more than 1,000 Chinese drug firms that sell products domestically will likely have to merge, fold or make more lucrative drugs due to the costs of complying with the regulations. The SFDA wants to streamline and strengthen the Chinese drug industry, as well as make drugs produced in the country more attractive for export. Firms that consider themselves chemical makers but produce APIs may be able to avoid the new GMP regulations, as the SFDA only assesses registered drug makers.

Source: Chemical & Engineering News