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(guò)“推進(jìn)行政審批便利化、簡(jiǎn)化產(chǎn)品注冊(cè)審評(píng)審批、鼓勵(lì)藥品醫(yī)療器械創(chuàng)新、強(qiáng)化教育培訓(xùn)和信息服務(wù)”4方面26條具體舉措,進(jìn)一步深化“雙創(chuàng)雙服”,推進(jìn)醫(yī)藥產(chǎn)業(yè)發(fā)展。其中,在鼓勵(lì)藥品醫(yī)療器械創(chuàng)新方面,《措施》提出,鼓勵(lì)通過(guò)一致性評(píng)價(jià)的藥品推廣使用。對(duì)通過(guò)質(zhì)量和療效一致性評(píng)價(jià)的仿制藥,企業(yè)可在說(shuō)明書(shū)、標(biāo)簽中予以標(biāo)注,便于醫(yī)務(wù)人員和消費(fèi)者選擇使用。鼓勵(lì)經(jīng)典名方中藥復(fù)方制劑注冊(cè)生產(chǎn)。對(duì)來(lái)源于國(guó)家公布目錄中的古代經(jīng)典名方且無(wú)上市品種的中藥復(fù)方制劑,實(shí)施簡(jiǎn)化審批,支持幫扶企業(yè)按要求向國(guó)家申報(bào)。同時(shí)《措施》明確,支持藥品經(jīng)營(yíng)連鎖化發(fā)展。鼓勵(lì)藥品經(jīng)營(yíng)企業(yè)吸收社會(huì)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(yíng)銷(xiāo)網(wǎng)絡(luò)設(shè)施發(fā)展藥品零售連鎖經(jīng)營(yíng)。允許藥品零售連鎖企業(yè)開(kāi)展執(zhí)業(yè)藥師遠(yuǎn)程藥事服務(wù),10家門(mén)店至少配備3名執(zhí)業(yè)藥師,每增加10家門(mén)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(yàn)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.