The State protects the resources of wild herbal drugs and encourages domestic cultivation of herbal drugs.
CHAPTER
Ι.
THE CONTROL OF DRUG
MANUFACTURING ENTERPRISES
Article 4 The establishment of a drug manufacturing enterprise must be approved by the competent authorities in charge of the production and management of drugs of the relevant province, autonomous region or municipality, and sanctioned by its health administrative agency. A "drug manufacturer certificate" will be issued by the health ad-
ministrative agency. Without the certificate, no "business li-
cense" will be granted by the local industrial and commercial
management agency.
A date of expiration should be fixed for each "drug manufacturer certificate", and an application for the re- newal of a certificate should be submitted before it expires. Relevant regulations of the certification procedure will be stipulated by the Ministry of Public Health.
Article 5 A drug manufacturing enterprise should be established on the following basis:
1) It should be staffed with an adequate number of phar- macists or technical personnel with a title equivalent to or higher than associate engineer, and skilled workers adaptable
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to the scale of drug production.
Enterprises for the preparing and slicing of herbal drugs should be staffed with pharmaceutical professionals familiar with the property of drugs and registered with the health bureau above the county level, if pharmacists or technical personnel with a title equivalent to or higher than associate engineer are not available.
2) It should have adequate premises and equipment adaptable to the scale of drug production, as well as a suitable hy- gienic environment.
3) It should have a department or a group of qualified analysts equipped with necessary instruments to examine
the quality of drugs.
Article 6 Drug must be manufactured pursuant to the provisions prescribed in the technological manual, and the data of production should be recorded completely and accu rately.
Herbal drugs must be prepared and sliced in compliance with the specifications of the "Pharmacopoeia of the People's Republic of China" or the processing norms stipulated by the health bureau of province, autonomous region or municipality. Article 7 Raw materials and excipients used in drug production and the containers and packaging materials in direct contact with drugs should be of a grade suitable for phar- maceutical purposes.
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