DRUG ADMINISTRATION LAW OF THE
PEOPLE'S REPUBLIC OF CHINA·2019
Chapter IV drug manufacturing
China Pharmaceutical University
Harry Liu
+86-13851619607
2021.11
• http://law.npc.gov.cn/FLFG/
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• http://www.nmpa.gov.cn
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• Article 41 To engage in pharmaceutical production enterprises, it is
required to obtain the Drug Manufacturing Certificate by approval of
the drug regulatory authority of the people's government of the
province, autonomous region or municipality directly under the
Central Government. No one may manufacture drugs without the
certificate.
• The valid term and the scope of manufacturing shall be indicated in
the Drug Manufacturing Certificate. For renewal of the certificate on
expiration, reexamination is required.
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• Article 42 A drug manufacturer to be established shall meet the following
requirements:
• (1) having legally qualified pharmaceutical and necessary technical workers;
• (2) having the premises, facilities, and hygienic environment required for
drug manufacturing;
• (3) having the institutions and personnel capable of quality control and
testing for drugs to be produced and the necessary instruments and
equipment;
• (4) having rules and regulations to ensure the quality of drugs, in line with
the Good Manufacturing Practice for Pharmaceutical Products (GMP)
formulated by the drug regulatory authority under the State Council in
accordance with this Law.
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• Article 43 To engage in pharmaceutical production activities, it is
necessary to abide by the quality management regulations for
pharmaceutical production, establish and improve the quality
management system for pharmaceutical production, and ensure that
the entire process of pharmaceutical production continues to meet
statutory requirements.
• The legal representative and principal responsible person of the
pharmaceutical production enterprise shall be fully responsible for the
pharmaceutical production activities of the enterprise.
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• Article 44 The drug shall be produced in accordance with the national drug
standard and the production process approved by the drug regulatory authority.
Production and inspection records shall be complete and accurate and shall not be
fabricated.
• Drug manufacturers shall perform quality test of the drugs produced; With the
exception of the processing of prepared slices of Chinese crude drugs, a drug shall
be produced in conformity with the National Drug Standard and with the
production processes approved by the drug regulatory department under the State
Council, and the production records shall be complete and accurate. The said
processing procedures shall be submitted to the drug regulatory department under
the State Council for the record; no drugs that do not meet the national drug
standards or that are not produced according to the processing procedures for the
prepared slices of Chinese crude drugs formulated by the drug regulatory
department of the people’s government of the province, autonomous region, or
municipality directly under the Central Government may be released or sold.
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• Article 45 The drug substances and excipients for the manufacture of
pharmaceutical products shall meet the requirements for medicinal use
and the quality management standards in GMP.
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• Article 46 Packaging materials and containers which directly contact
with pharmaceuticals shall meet the requirements for medicinal use
and the standards of protect the health and safety for human beings.
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• Article 47 Drug manufacturers shall perform quality test of the drugs
produced; no drugs that do not meet the national drug standards may
be released.
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• Article 48 Pharmaceutical packaging should be suitable for the quality
of the drug, convenient for storage, transportation and medical use.
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• Article 49 A label shall be printed or stuck on the drug package
together with an insert sheet, as required by regulations.
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• Article 50 Staff members of market authorization holder, drug
manufacturers, drug distributors and medical institutions who are in
direct contact with drugs shall undergo health checkup annually. No
one who suffers from infectious diseases or any other diseases which
may cause contamination to drugs may engage in any work in direct
contact with drugs.
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Thank you!
Q&A
柳鹏程
中国药科大学
13851619607
liupcmail@163.com
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