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
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
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
Will the Chinese GMP Certification
Cancellation Result in Deregulation of Quality Management in Chinese many
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.
pharmaceutics & biochemicals category is one of our main focused category.
Below pharmaceutical manufactures are also big and
renowned factories in China.
Davi Pharmaceutical Co., Ltd.
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