河北省药品监督管理局近日印发《关于支持医药产业高质量发展的若干政策措施》,明确将通过“推进行政审批便利化、简化产品注册审评审批、鼓励药品医疗器械创新、强化教育培训和信息服务”4方面26条具体举措,进一步深化“双创双服”,推进医药产业发展。其中,在鼓励药品医疗器械创新方面,《措施》提出,鼓励通过一致性评价的药品推广使用。对通过质量和疗效一致性评价的仿制药,企业可在说明书、标签中予以标注,便于医务人员和消费者选择使用。鼓励经典名方中药复方制剂注册生产。对来源于国家公布目录中的古代经典名方且无上市品种的中药复方制剂,实施简化审批,支持帮扶企业按要求向国家申报。同时《措施》明确,支持药品经营连锁化发展。鼓励药品经营企业吸收社会资本,与行业外企业合作,利用行业外企业现有营销网络设施发展药品零售连锁经营。允许药品零售连锁企业开展执业药师远程药事服务,10家门店至少配备3名执业药师,每增加10家门店增配1名执业药师。药品零售企业从事中药饮片质量管理、验收。
Hebei Provincial Drug Administration recently issued "Several Policies and Measures for Supporting the High Quality Development of the Pharmaceutical Industry". It is clear that 26 specific measures will be taken to further promote the facilitation of administrative examination and approval, simplify the examination and approval of product registration, encourage the innovation of pharmaceutical and medical devices, and strengthen education, training and information services. Deepen the "double creation and double service" and promote the development of the pharmaceutical industry. Among them, in encouraging innovations in pharmaceutical medical devices, the "Measures" proposed to encourage the promotion and use of drugs through consistent evaluation. For generic drugs that pass the consistency evaluation of quality and efficacy, enterprises can label them in the instructions and labels, which is convenient for medical staff and consumers to choose and use. Encourage the registration and production of traditional Chinese medicine compound preparations. Simplified examination and approval shall be carried out for the traditional Chinese medicine compound preparations originating from the famous ancient classical prescriptions in the national publication catalogue and without the listed varieties, so as to support enterprises to declare to the state as required. At the same time, the "Measures" clearly support the chain development of drug business. Pharmaceutical enterprises are encouraged to absorb social capital, cooperate with enterprises outside the industry, and use existing marketing network facilities of enterprises outside the industry to develop drug retail chain operation. Drug retail chains are allowed to conduct remote prescription auditing for licensed pharmacists. At least three licensed pharmacists are assigned to 10 stores, and one licensed pharmacist is added to every 10 stores. Pharmaceutical retail enterprises are engaged in quality management and acceptance of Chinese herbal pieces.