Dive Brief:
- China's Food and Drug Administration (CFDA) was found to have inspected less than half of the number of domestic pharmaceutical manufacturing sites as compared with 2014 according to an annual report from CFDA's Center for Food and Drug Inspection, reports Regulatory Focus.
- Despite the decline in site inspections, the percentage of sites experiencing rectification inspections and issuance of warning letters increased by 13%.
- The report's findings follow recent decisions by the U.S. FDA to closely watch the Chinese drug market for noncompliant domestic pharmaceutical manufacturers.
Dive Insight:
Earlier this year the number of Chinese pharmaceutical companies on the U.S. FDA's import alert list for manufacturing violations rose to 44 firms. The CFDA has said that it would crack down on corruption and quality control issues, though the recent annual report from the regulator's Center for Food and Drug Inspection shows a significant decline in manufacturing site inspections, Regulatory Focus reports.
For 2015, the CFDA conducted 221 inspections for proper manufacturing certification, for which only 4% failed and 68 of the enterprises received warning letters. These statistics show a decline from those of 2014, when the CFDA conduction 482 inspections and issued 146 warning letters, according to the annual report.
The regulator says it has been finding critical deficiencies in data integrity and that most violations were related to control and assurance, documentation management, and equipment, qualification, and verification.
China is the world's second-largest drug market. The Chinese State Council announced in February that the country would undertake consolidation of the pharmaceutical market in order to improve product traceability systems and enhance overall supervision of manufacturing sites.
