人民視覺
中藥審批邊緣化
The China Medicines Review Edge.
審評通過率低、投資大、周期長、風險高，讓很多企業對中藥新藥研發望而卻步
Low pass rates, high investment rates, long cycles, high risks, and many businesses have turned their back on new Chinese medicines.
屠呦呦獲諾獎對中醫藥行業無疑是利好，但中藥審批正在被邊緣化。
The award is certainly good for the Chinese medicine industry, but the Chinese medicine trial is being borderlined.
國家食藥監管總局網站的數據顯示，目前全國獲批的藥品生產批文為16.9萬件，而中藥隻佔其中的35.7%。近3年的藥品審評年度報告顯示，2012—2013年，獲批的中藥數量分別為27個和37個，隻佔當年新藥總數的約6%。而2014年獲批的501個新藥批文中，中藥隻有11個，僅佔2.19%。
According to data from the website of the National Directorate of Drug Surveillance, 169,000 pharmaceutical products are currently approved throughout the country, of which 35.7 per cent are manufactured by Chinese medicine, and the annual drug review report for nearly three years shows that between 2012 and 2013, the total number of approved drugs in China was 27 and 37, or only about 6 per cent of the total number of new drugs for the year. In 2014, of the 501 new medicines, only 11, or only 2.19 per cent, were approved.
由地黃、山藥、山茱萸、茯苓、澤瀉、丹皮六味藥組方而成的六味地黃丸，是宋代兒科專家錢乙創制的，如今成為滋陰補腎、養生保健的千年良藥。六味地黃丸是國內不少企業的“當家花旦”。如果按當下的審批流程，六味地黃丸基本沒有上市的可能。
The six-coloured yellow pill, made from the ground yellow, the mountain medicine, the molluscs, the saber, the saber, the saber, the saber, and the saline, was created by the Song Dynasty Physics Specialist, and is now a thousand-year-old medicine to feed kidneys and health care. The six-coloured yellow pill is a “baby” of many businesses in the country. If the current process of approval is followed, the six-coloured yellow pill is virtually impossible to market.
六味地黃丸作為補腎滋陰的基本藥物，其對應的証是腎陰虛。除了腎病以外，神經系統、心血管系統等疾病都會出現類似的症狀，服用六味地黃丸都有效。中藥治病對應的是一種態(即証候)，而藥品注冊辦法要求對應的首先是病，如果聲稱治療多種疾病，每個病種均要觀察足夠的病例數，如此則需要成千上萬的病例觀察，幾十年可能也做不完。
In addition to kidney disease, diseases such as the nervous system, cardiovascular system, etc., are subject to similar symptoms, and the use of the six-coloured yellow pill is effective. The medicament response to the disease is one (i.e., a sign) and the medicament manual requires that the first response is a disease, and if it is claimed that there are many diseases, there are enough cases per disease to be observed, which would require thousands of cases to be observed and possibly done for decades.
中國中醫科學院廣安門醫院中藥研發中心主任黃世敬指出，針對疾病的單靶點，是化藥的強項，而中藥方對應的是一個面或網絡，用單一疾病靶點永遠說不清一個面或整體。當然中藥方也有對應單一疾病的成功案例，但是絕大多數是對應於証候的。如果注冊新藥隻針對病，將証置於次要地位或根本不管其証，就把絕大多數中藥方排除掉了。他建議，政策應有寬度和探索空間，為中藥創新鬆綁，中藥新藥的注冊評審需要體現中醫辨証的特點。
The Director of the Drug Research and Development Centre at the General Anmen Hospital, Chinese Medical Science School, Huang Shizheng, pointed out that single-targeting for disease is the strength of a chemical drug, while Chinese medicine is directed at one face or network, with one face or whole being never understood. Of course, Chinese medicine also has success in dealing with a single disease, but most of them are. If new drugs are listed for disease, they are given secondary status or not at all, most of them are eliminated.
中藥要開發為成藥，須經藥效評價，建立動物模型，讓小白鼠“點頭”。一位研究者用小老鼠做七情致病模型，用鋏子夾老鼠尾巴讓其在空中晃蕩，老鼠驚恐傷腎了。動物學家回答卻是，老鼠以為你和它玩呢。在藥效學指標上，動物模型按西醫理論構建，與中醫的証不相適應，最后抹殺了中藥的實際療效。
The Chinese medicine has to be developed as a drug, and the animal model has to be evaluated for its effects, so that the mouse can “nobly” its head. A researcher uses a mouse to make a seven-mitigation model, with a rat's tail in the air, and the mouse scares the kidneys. The animal scientist answers, however, that the mouse thinks you're playing with it. On the pharmacological marker, the animal model is constructed on a Western medical basis and does not match the evidence of Chinese medicine, and eventually wipes out the therapeutic effects of the drug.
北京同仁堂研究院院長解素花說，中醫新藥療效評價存在著趨同傾向，即中藥新藥均按統一的指導原則、一個標准來進行評價，缺乏個性化特點的觀察和總結，不能很好體現中醫的整體觀念和靈活用藥用方辨証論治的理念。
According to the director of the Beijing Academy, there is a convergence of views on the efficacy of the new Chinese medicine, which is based on one-size-fits-all guidelines, one standard, a lack of individualized observations and general findings, and a poor perception of the medical landscape and the concept of prophylactic medicine.
中藥西管，過於西化的評價標准不符合中藥的特點，也阻礙了中醫藥的發展。我國中藥新藥研發審評通過率低、投資大、周期長、風險高，很多企業和科研機構對中藥新藥研發望而卻步，使得中藥新藥在評審過程中所佔比重逐年下降。
China’s China Medicines Development Review is low, high investment, long-cycle, high risk, and many businesses and scientific institutions are looking at new Chinese medicines, reducing the share of new Chinese medicines in the review process from year to year.
廣藥集團有關負責人指出，中藥是祖先給我們留下的寶貴遺產，是數千年積累下來的智慧結晶，要珍惜、保護、開發中醫藥這一寶庫，並將其轉化為我國中醫藥產業發展的優勢，而不能像現在這樣“捧著金碗討飯吃”。
According to the Director, Chinese medicine is a precious legacy of our ancestors. It is a product of wisdom that has accumulated for thousands of years, cherishing, protecting, developing and developing medicine, and turning it into an advantage in the development of medicine in our country, rather than “bringing a bowl of gold for food” as it is now.
“新藥審評審批制度的改革必須大膽推進。”國家食藥監管總局副局長孫咸澤強調，為了鼓勵創制新藥，要在制度上創新、審評上優先、程序上簡化、技術上溝通，真正形成有利於激發創新活力的審評審批制度。
“The reform of the new drug review system must be carried forward boldly.” The Deputy Director General of the National Drug Control Authority, Samazawa, has stressed that in order to encourage the creation of new drugs, it is necessary to create institutional innovations, give priority to the review process, streamline procedures, and communicate technologically in order to create a genuine system of review and approval that is conducive to the creation of new dynamics.
古方肥了外人田
Gu Fong has fattened the outsider's fields.
經典名方在評審政策上不能千篇一律，應分類管理，使其古為今用，否則很難轉化為我國中醫藥產業發展的優勢
The classics are not uniform in their review policies, they should be sorted so that they can be used for the time being, or it will be difficult to translate into an advantage in the development of the pharmaceutical industry in our country.
北京的林先生國慶期間去了趟日本。好多朋友親戚托他代購 “獨龍散”，用來治療兒童感冒。這個由地龍、荊芥穗、甘草、角刺組成的中藥方，來自宋代的《小兒衛生總微論文》。讓他不解的是，中國老祖宗的方子，為啥國內不能生產，還得去日本買？
Mr. Lin went to Japan during Beijing’s national celebration. Many friends and relatives asked him to buy “single dragons” to treat children’s colds. This Chinese medicine, made up of Dragons, mustards, licorices, horns, is a “total child’s health theory” from Song Dynasty.
小青龍湯、葛根湯、小柴胡湯、大柴胡湯……很多古方中成藥在國外生產銷售，在我國卻要當成新藥進行嚴格審批。韓國保健衛生部規定，11種古典醫書裡的處方，無須做臨床等各種試驗，藥廠直接生產。日本厚生省批准使用我國《傷寒雜病論》的210個古方生產漢方藥，在國際市場佔有率達80%以上。因為其寬鬆的政策環境，中國的寶貝成了外國人的搖錢樹，古方肥了外人田。
The Ministry of Health and Hygiene of Korea has ruled that 11 classical medical books have been prescribed without having to be used for various tests, such as bedfalls, to produce medicine. The Ministry of Health and Welfare of Japan has approved the use of 210 antiquated Chinese-origin drugs in our country's Cold War Disorders, which account for more than 80% of international market use. Because of its liberal policy environment, China's baby has become a foreign country's money-rich tree, and has developed a foreign land.
有人擔心，古人和今人不一樣，適合古人用的藥，今人還能放心吃嗎？中國中醫科學院廣安門醫院副院長仝小林認為，盡管環境有改變、營養有改善，疾病譜也有改變，但是疾病的發病規律大致是一樣的，80%的古方在臨床上應用普遍。
Some fear that the ancients are not the same as today’s ones, and that they will be able to take them. The Vice-President of the Chinese Medical Academy’s Guanganmen Hospital, Kobayashi, believes that despite changes in the environment, improved nutrition, and changes in disease profiles, the pathology of the disease is largely the same, with 80% of the ancient prescriptions being common in bed.
“湯者，蕩也。丸者，緩也。”丸散膏丹不同的劑型，在臨床上有不同的應用。湯藥主要是用於危重急症﹔而丸劑主要用於慢性病的調理。仝小林認為，中藥更換劑型也要審批，傳統中藥豐富的劑型變成單一的湯藥，也妨礙了中藥在臨床的應用。
"Tom, tom, tom, tom, tom, tom, tomb, tomb, tomb, tomb, tomb, tomb, tomb, tomb, tompo, tomb, tomp, toll, toll, toll, toll, tolling, toll, tolling, toll, tolling, tolling, tolling, tolling, tolling, tolling.
按古方生產成藥需按照中藥注冊分類6.1類中藥復方制劑申報注冊。《中藥注冊管理補充規定》指出，來源於古代經典名方的中藥復方制劑，是指目前仍廣泛應用、療效確切、具有明顯特色與優勢的清代及清代以前醫籍所記載的方劑。該類中藥復方制劑的具體目錄由國家食藥監管總局協助有關部門制定並發布。符合相關條件的該類中藥復方制劑，可僅提供非臨床安全性研究資料，並直接申報生產。
According to the regulations governing the management of the Chinese drug register, the Chinese drug compound, which is derived from ancient classics, is a generic, therapeuticly relevant, clearly identifiable and advantageous generic and pre-descent medicine-recorded formulation. The catalogue of the drug-recording agent in this category is developed and distributed with the assistance of the relevant ministry.
仝小林建議，對於老祖宗傳下來的經典名方，在評審政策上不能千篇一律，應分類管理：無毒的中藥直接授予生產許可﹔含毒中藥的藥方，如烏頭桂枝湯，進行安全性評價，獲批后再生產﹔創新藥直接走新藥的審批流程。
Kobayashi suggested that there should be no uniformity in the review policy for the classics of the ancestors: non-toxic Chinese medicine was given a direct permit to produce; the drug containing the poison, such as cinnamon soup, was evaluated for safety and was subsequently recreated; and the new drug was created through a process of approval of the new drug.
中藥經典名方是中藥新藥研發的重要源泉和最佳素材。2015年國務院《關於改革藥品醫療器械審評審批制度的意見》提出，將簡化來源於古代經典名方的復方制劑的審批，此外，國家正在加緊制定中藥經典名方名單，逐步建立中醫藥傳統知識專門保護制度。
The Chinese classic is an important source and the best material for the development of new Chinese medicines. In 2015, the State Department's Opinion on the Reform of the System for the Review and Evaluation of Pharmaceutical Medical Devices proposed that it should be simplified from the approval of an antiquated generic product. In addition, the country is working on a list of classic Chinese medicines and is gradually developing a system of specialized protection for Chinese medicine.
廣藥集團有關負責人指出，專利制度是保護中藥古方有力的武器，現有的專利法規不利於中藥企業申請專利權，很多中藥難以達到專利新穎性、創造性和實用性的要求，導致無法申請專利。要完善專利保護制度，充分考慮中藥的特殊性，為經典名方加蓋“防盜水印”。
According to the general drug group, the patent system is a powerful weapon to protect Chinese medicine, there are patent laws that are not conducive to China’s pharmaceutical companies applying for patent rights, and many Chinese drugs are difficult to meet the requirements of patent innovation, creativity and practicality, making it impossible to apply for patent money. The system of proprietary protection should be perfected, taking fully into account the special nature of Chinese medicine, and a “watermark against theft” should be added to the classic name.
院內制劑很尷尬
The in-hospitals are embarrassing.
審批門檻大幅度提高，而售價又受多因素制約，導致科研人員不願研發、生產者不願生產
There has been a significant increase in the price of the examination, which has been subject to multifactorial regulations, which has led scientists to be reluctant to develop and produce.
紅紗條在皮膚潰瘍界可是個“明星”。北京中醫醫院赴汶川抗震救災帶上了“紅紗條”，使許多傷口潰爛感染的傷員避免了截肢厄運。北京中醫院中醫外科主任董建勛介紹，紅紗條全名是朱紅膏紗條，把能活血生肌的朱紅膏涂抹在紗條上，激發氣血運行，刺激創面肉芽組織生長，激活生長緩慢或不生長的創面。
Red veils are "stars" in the skin-skinned area. The Beijing Medical Hospital brought a "Red Ribbon" to Wenchuan to save the lives of many of the wounded who suffered from a broken infection. In Beijing, the Chief Medical Surgery Officer of the Central Hospital introduced the Red Ribbon, full name of which is the Chu red saint, rubs on the sacrament that is capable of living blood muscles, stimulates the circulation of blood, stimulates the growth of mammoth tissues, and activates the creation of slow or slow growth.
類似紅紗條，按照傳統方法炮制的丸、散、膏、丹，僅限於醫療機構內部使用，被稱為中藥院內制劑。但是，由於種種原因，現在很多都已停產。
Like the red bars, pills, scattered, ointment, and Dan produced according to traditional methods are restricted to the inside of a medical facility and are called Chinese medicine. But, for a variety of reasons, many are now out of production.
治療抑郁症的院內制劑——開心解郁丸，卻讓黃世敬難開心。他從2006年開始一直在做研發，要等到明年才能拿到制劑臨床批件。到臨床結束獲配制批件至少還需要3—4年。10多年做一個制劑時間還不算長，有的制劑20年過去了還沒做出來。院內制劑開發既不算課題，晉職獎勵又不能體現，只是出於學科建設和臨床需求，科研人員費力不討好，年輕人都不願參加。
It took at least three to four years to get the package at the end of the bed. It took more than 10 years to make a single dose, some of which had not been produced for 20 years. The in-house development was neither a subject nor a reward, but simply a need for science and bed preparation, and scientists did not spend enough time and young people did not want to attend.
從注冊審批的角度來說，院內制劑審批的定位不清，用審批新藥的方式來審評。由於強調安全性，要求其中沒有毒性藥材及配伍禁忌，不能有藥典以外的藥材，注射液干脆不能做，此舉勢必將臨床原創束縛在極其狹小的范圍。常規毒理、藥理藥效等一個都不能少，在拿到臨床批件前，至少要花50萬—100萬元。
From the point of view of the register, there is a lack of clarity in the selection of in-house medications, which are judged in the form of new medications. As a result of the emphasis on safety, there is a requirement that there are no toxic drugs and accessories, no drugs outside the protocol, and no injection fluids, the situation is simply impossible.
黃世敬說，院內制劑與新藥研發的主要區別是觀察樣本量，院內制劑隻能在醫院單中心做，樣本量較少(不少於60例)。新藥病例要求在多中心完成(大約400例)。但正因為是單中心，病例收集受限，加上投入嚴重不足，不如新藥可以多找幾家醫院聯合做。院內制劑的研發難度並不亞於新藥研發，注冊評審亦類似於新藥。醫院制劑的臨床做下來，需要經費大約150萬—300萬元。
Hwang said that the main difference between intra-hospital preparations and new drug development is observation of samples, which can be done only in single-hospital centres, with fewer samples (many more than 60 cases). New drug cases require completion in multiple centres (about 400 cases).
廣安門醫院一位名老中醫治療腫瘤的方子，在臨床上療效特別好，但開發成新藥或制劑基本沒可能，比如處方中含有藥典未收載的藥物——梨藤根。根據藥品注冊管理辦法，首先要對梨藤根建立藥材標准，需對其來源、有效成分、質量控制及藥效、藥理和毒理等進行研究。面對如此浩大的工程，開發新藥的事隻能擱淺。
An old Chinese doctor at Guanganmen Hospital treats tumors and treats them in bed, but it is almost impossible to develop new drugs or formulations, such as prescriptions containing medicines that have not been taken into account in the prescriptions, i.e., pine root. According to the administration of the drug register, the first thing to be done is to set up a drug standard for pine root, which requires research on its origin, active composition, quality control, and efficacy, pharmacology, and toxology.
玉紅膏在臨床上是一種特別好的創傷藥，定價才幾元，成本卻接近20元。這種藥納入醫保統一定價，生產一盒賠一盒，藥膏生產時斷時續，難以滿足臨床的需要，以至於網上已經炒到每盒70—80元。治療痔瘡的院內制劑參柏袋泡劑雖獲制劑批件3年了，卻一直不能生產，也是因為定價問題，虧本難賺吆喝。
The jade cream is a very good cure for trauma in the bed at a price of only a few dollars, but at a cost of nearly $20. This medicine is included in the health insurance policy at a price of one box at a price, and it is difficult to satisfy the need for a bed at a time when the ointment is produced, so that it has been fired online at $70-80 per box. For three years, the in-hospital scaffolding agent for the treatment of the scaffolding has been unable to produce it, and because of the price, it is difficult to make a living.
院內制劑審批門檻大幅度提高，而售價又受多因素制約，導致科研人員不願研發、生產者不願生產。政策掣肘，讓院內制劑難見天日。
There has been a significant increase in the price of in-house drugs, which is subject to a multi-factor policy that discourages researchers from developing and producing products.
黃世敬認為，院內制劑作為中藥新藥創新源頭，不能用新藥的標准來要求，兩者要拉開檔次，否則院內制劑就沒法開發了，創新的苗頭容易被扼殺。
Hwang believes that, as a new source of Chinese medicine, the in-house drug cannot be required by the criteria of the new drug, that it has to be kept open, that it cannot be developed, and that the new seedlings can easily be strangled.
中醫藥國情調研組執行組長陳其廣研究員建議，院內制劑應由審批制改為備案制，由同級中醫藥行政部門備案，由醫療機構自主管理，保証質量。
The Executive Director of the China Medicines National Institute recommended that the intra-hospital preparations should be reviewed and changed to ready-made, and that they should be prepared by the same level of medical and pharmaceutical administration, independently managed by the medical authorities, to ensure quality assurance.
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