China Intensifies Supervision on Production and Quality of Essential Drugs

China’s State Food and Drug Administration (SFDA) issued new plans for ensuring the quality of essential drugs on November 25, 2009. All provincial food and drug administrations will need to focus on strengthening essential drug production and quality control supervision work. They will also need to prioritize on the essential drug list and ensure the implementation of the essential drug system.

Regulators will increase the responsibilities of the main QA person at drug manufacturing facilities and also encourage improvements of quality assurance systems. The provincial bureaus will organize inspections based on the pharmaceutical production processes and ensure GMP compliance.

Other plans include strengthening the daily monitoring of essential drug production, increasing oversight of drugs sales, and severely cracking down on illegal operations. There will also be increased monitoring of adverse drug reactions, improvements in issuing drug safety warnings, and implementing emergency responses.

To implements these plans, the SFDA will organize inspection teams to conduct audits of facilities during production and quality control.

Essential drugs will eventually be fully electronically supervised through a barcode system.