河北省藥品監(jiān)督管理局近日印發(fā)《關(guān)于支持醫(yī)藥產(chǎn)業(yè)高質(zhì)量發(fā)展的若干政策措施》,明確將通過“推進行政審批便利化、簡化產(chǎn)品注冊審評審批、鼓勵藥品醫(yī)療器械創(chuàng)新、強化教育培訓和信息服務”4方面26條具體舉措,進一步深化“雙創(chuàng)雙服”,推進醫(yī)藥產(chǎn)業(yè)發(fā)展。其中,在鼓勵藥品醫(yī)療器械創(chuàng)新方面,《措施》提出,鼓勵通過一致性評價的藥品推廣使用。對通過質(zhì)量和療效一致性評價的仿制藥,企業(yè)可在說明書、標簽中予以標注,便于醫(yī)務人員和消費者選擇使用。鼓勵經(jīng)典名方中藥復方制劑注冊生產(chǎn)。對來源于國家公布目錄中的古代經(jīng)典名方且無上市品種的中藥復方制劑,實施簡化審批,支持幫扶企業(yè)按要求向國家申報。同時《措施》明確,支持藥品經(jīng)營連鎖化發(fā)展。鼓勵藥品經(jīng)營企業(yè)吸收社會資本,與行業(yè)外企業(yè)合作,利用行業(yè)外企業(yè)現(xiàn)有營銷網(wǎng)絡設施發(fā)展藥品零售連鎖經(jīng)營。允許藥品零售連鎖企業(yè)開展執(zhí)業(yè)藥師遠程藥事服務,10家門店至少配備3名執(zhí)業(yè)藥師,每增加10家門店增配1名執(zhí)業(yè)藥師。藥品零售企業(yè)從事中藥飲片質(zhì)量管理、驗收。
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.