- Chinese health regulators have released draft guidelines aimed at expanding oversight of pharmaceutical production in the country, part of comprehensive efforts to overhaul drug quality in a rapidly expanding market.
- Inspections by the Chinese Food and Drug Administration are slated to begin November 1, after a period for manufacturers to review their production processes, according to a research note from Goldman Sachs' Richard Yeh.
- Under the proposed guidelines, drugs would be considered "counterfeit" if drugmakers fail to conduct studies demonstrating comparable product safety for currently unapproved processes by June 30, 2017, according to Goldman Sachs.
Along with India, China makes many of the active pharmaceutical ingredients used in drugs worldwide. But the growing pharmaceutical industry has been dogged by quality and safety concerns, leading to stepped-up oversight from the U.S. Food and Drug Administration.
The FDA has imposed import bans on products from 54 Chinese drugmakers (and 44 Indian firms) for violations of good manufacturing practices. Warning letters frequently cite problems with quality control and maintaining basic sanitary conditions. Data manipulation is another frequent concern.
In response, Chinese authorities have mounted a wide-ranging effort to raise standards and hold drugmakers accountable. A nationwide scandal over a black-market vaccines ring prompted widespread anger and led to hundreds of arrests late last year.
The draft guidelines released last week outline the path forward for inspections of manufacturing processes. Drugmakers will have until October 1 to inspect their own procedures and report unauthorized processes to the CFDA, according to Goldman's Yeh. Unannounced inspections will follow beginning on November 1 and companies with unreported changes in their production could face penalties.
"The proposed guidelines reaffirm that ongoing reform is targeting the whole pharma value chain," said Yeh in the note. "These new guidelines, once finalized and implemented, represent another step towards an upgrade in drug quality for the Chinese pharma market."
Comments on the guidelines will be accepted through September 10, 2016, according to the CFDA.