The newly revised Drug Administration Law has come into effect on December 1, 2019. This amendment is the most major amendment of this law in 18 years. One of the major amendment is the cancellation of GMP and GSP certification. In other words, Chinese GMP certification which was very important to many pharmaceutical enterprises in China has been officially canceled.

 
Why Chinese GMP Certification is Canceled?

All Chinese drug manufacturers required Good Manufacturing Practice (GMP) certification. GMP certification was previously thought to approve the operation after obtaining the certificate, however, many pharmaceutical enterprises begin to relax after obtaining GMP certification by all manner of means, so that the regulator has to use great efforts every year to investigate and revoke GMP certificates of enterprises breaking law. 

Since GMP and GSP certifications themselves are entry licenses, these certifications will likely lead some enterprises to attach great importance to the certifications themselves rather than on quality management.
 
Will the Chinese GMP Certification Cancellation Result in Deregulation of Quality Management in Chinese many pharmaceutical enterprises?

The answer is absolutely no. The cancellation of GMP and GSP certifications will not result in the deregulation of the quality management of the manufacture and trade of drugs; rather, the New Law establishes a higher requirement for enterprises.

 
The New Law extinguishes the current requirement that drug administration authorities shall assess drug manufacture enterprises and drug trading enterprises, and issue assessment certificates. Instead, the New Law requires that drug manufacturing enterprises and drug trading enterprises establish and improve the quality management systems of manufacture and trade of drugs, and ensure that the process of manufacturing and trading of drugs always meets all legal requirements. In other words, a stricter form of supervision is implemented.
 
Drug manufacture enterprises and drug trading enterprises shall continually meet the requirements of the GMP and GSP, and ensure the full process of manufacture and trading of drugs is in full compliance with the laws and regulations. This regulatory change will be a huge challenge for any pharmaceutical enterprises with GMP and/or GSP certification(s) that are no longer able to continuously meet the requirements for certification after obtaining their certification(s).

 
To sum up, although Chinese GMP certification and Chinese GSP certificate is canceled, the supervision of pharmaceutical enterprises is stricter than ever in China and the entry level of Chinese pharmaceutical enterprises are higher.
 
For those pharmaceutical enterprises which have been granted the GMP certificates consecutively, it means that they have been following the Good Manufacturing Practice and such regulation update may not have much impact to them. 

About foreign medial companies in China

As one of the world’s fastest-growing medical markets, China offers great sourcing and manufacturing opportunities for foreign medical companies. However, due diligence and appropriate quality standards are key factors that you must take into account when you consider sourcing or manufacturing in China. Excellent quality systems that comply with the China Food and Drug Administration (CFDA), U.S. FDA, and international standards are often needed in order to sell your China-manufactured medical products in the West. For details, you may need to consult professional.

In OKCHEM, pharmaceutics & biochemicals category is one of our main focused category. Below pharmaceutical manufactures are also big and renowned factories in China.
 
Zhejiang Davi Pharmaceutical Co., Ltd.

Hunan Huari Pharmaceutical Co. Ltd

Anhui BBCA Pharmaceutical Co. Ltd

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