the content of drug advertisement shall be truthful and lawful, and shall be based on the insert sheet approved by the drug regulatory agency of the state council.
药品广告的内容必须真实、合法,以国务院药品监督管理部门批準的说 明书为準,不得含有虚假的内容。
any newly established drug retailer shall be subject to approval and be granted the above certificate by the local drug regulatory agency at or above the county level.
开办药品零售企业,须经企业所在地县级以上地方药品监督管理部门批準并发给《药品经营许可证》。
the drug control institution affiliated to the drug regulatory agency of the state council is responsible for standardizing the national drug standard substance and reference substance.
国务院药品监督管理部门的药品检验机构负责标定国家药品标準品、对照品。
the drug regulatory agency shall take administrative enforcement to seal or seize the drugs and related materials proved to be potentially harmful to human health and shall.
药品监督管理部门对有证据证明可能危害人体健康的药品及其有关材料 可以采取查封、扣押的行政强制措施。
the drug regulatory agency shall inspect a drug manufacturer as to its compliance with the gmp requirements and issue a certificate to the manufacturer passing the inspection.
药品监督管理部门按照规定对药品生产企业是否符合《药品生产质量管理规范》的要求进行认证;对认证合格的,发给认证证书。
drug manufacturers shall conduct production according to the good manufacturing practice products (gmp) formulated by the drug regulatory agency of the state council based on this law.
药品生产企业必须按照国务院药品监督管理部门依据本法制定的《药品生产质量管理规范》组织生产。
only testing institutions accredited by the drug regulatory agency in conjunction with the quality and technical supervision agency of the state council may conduct medical device test.
经国务院药品监督管理部门会同国务院质量技术监督部门认可的检测机构,方可对医疗器械实施检测。
class i medical devices shall be inspected, approved and issued a registration certificate by the drug regulatory agency of the government of the municipalities with districts.
生产第一类医疗器械,由设区的市级人民政府药品监督管理部门审查批準,并发给产品生产注册证书。
it shall be subject to approval in advance by the local drug regulatory agency of the government of the province, autonomous region or municipality directly under the central government.
并须经所在地省、自治区、直辖市人民政府药品监督管理部门批準后方可配制。