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should be accompanied with relevant information such the method of production, the criteria of its quality, and the results of pharmacological and toxicological tests, and a sample of specified size.
A new drug will be approved for clinical use and a license issued by the Ministry of Public Health if the clinical trial or clinical verification has been completed and an appraisal of its efficacy has been made.
Article 22 With the exception of prepared slice of herbal drugs, the production of new drugs can only be carried Out when an approval document with an approval number has been issued by the Ministry of Public Health.
With the exception of prepared slice of herbal drugs, the production of drugs for which a national, provincial, auto- nomous regional or municipal standard has been established can only be carried out when an approval document
with an approval number has been given by the health bureau of province, autonomous region or municipality with the con- currence of the competent authorities in charge of the production and management of drugs at the same level.
Article 23 The quality of drugs must comply with a na- tional, provincial, autonomous regional or municipal standard.
"The Pharmacopoeia of the People's Republic of China" and drug standards promulgated by the Ministry of Public Health are national drug standards:
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The Commission of Pharmacopoeia subordinate to the Ministry of Public Health is responsible for the stipulation and revision of national drug standards.
Article 24 The Ministry of Public Health and the health bureau of province, autonomous region or municipality may establish a Committee of Drug Evaluation for the evaluation of new drugs and the re-evaluation of drugs on sale.
Article 25 The Ministry of Public Health should launch an investigation of drugs approved for production; the approved documentary number of a drug should be revoked if the efficacy is not confirmed, if the adverse reaction is found to be serious, or if the drug is otherwise found to be hazardous to the health of the people.
The production and sale of a drug should not be continued if its approved documentary number has been revoked; those already produced should be destroyed or disposed under the supervision of the local health administrative agency.
Article 26 The importation of a drug is prohibited if the efficacy is not confirmed, if the adverse reaction is found to be serious, or if it is otherwise found to be hazardous to the health of the people.
Article 27 The signing of a contract for the importa- tion of a drug which has not been imported previously should be approved by the Ministry of Public Health. An applica- tion for the importation of the drug should be accompanied
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