China's State Food and Drug Administration: Exploring the Integration of GMP Certification and Production License into a Single Certificate

The State Food and Drug Administration (SFDA) recently released its 2016 drug inspection report, marking a significant shift in drug supervision and management. Ding Jianhua, Director of the Drug and Chemical Supervision Department of the SFDA, pointed out that the focus of future drug supervision will further shift towards inspection and oversight. "We are considering exploring the integration of Good Manufacturing Practice (GMP) certification and drug production licenses in the future, and strengthening in-process and post-process supervision."

In a recent media interview, Ding Jianhua stated that GMP certification has now been delegated to provincial-level food and drug regulatory departments. The SFDA ceased accepting GMP certification applications from January 1, 2016, meaning GMP certification will no longer be a "protective shield" for companies.

Ding Jianhua said that GMP certification is a fundamental and necessary requirement that drug manufacturers must follow during the production process. Drug production should inherently be conducted according to regulations, and this standard regulates a continuous and dynamic process. He emphasized that ensuring "continuous compliance" is the primary responsibility of enterprises, and the Drug and Chemical Supervision Department will increase inspections of enterprises and products to promote "continuous compliance."

“GMP certification for pharmaceuticals is essentially issuing a five-year valid certificate of conformity to pharmaceutical companies. Even if a company doesn't produce according to regulations, it can use the government's certification as a guarantee to evade its own responsibility,” said Ding Jianhua. He added that the future elimination of pre-approval supervision does not mean a lowering of drug quality standards; pharmaceutical companies will face more stringent inspections, especially unannounced surprise inspections.

According to the Drug Administration Law, establishing a pharmaceutical manufacturing enterprise requires approval from the drug regulatory department of the provincial, autonomous region, or municipality government where the enterprise is located, which will issue a “Drug Production License.” Without a “Drug Production License,” drug production is prohibited. Pharmaceutical manufacturing enterprises must organize production in accordance with the “Good Manufacturing Practice for Pharmaceuticals” formulated by the State Council's drug regulatory department based on the Drug Administration Law.

Currently, my country's GMP certification for pharmaceuticals, implemented in March 2011, is based on international standards. Enterprises and production lines that fail to meet the requirements are prohibited from production, making it known in the industry as the “strictest certification in history.” As part of the quality management system, Good Manufacturing Practice (GMP) for pharmaceuticals is a fundamental requirement for pharmaceutical production and quality management. It aims to minimize the risks of contamination, cross-contamination, confusion, and errors during the pharmaceutical production process, and to ensure the continuous and stable production of pharmaceuticals that meet their intended use and registration requirements.