[week leader] talk about hot news of the week (July 11, 2016 to July 15, 2016)

The exclusive report CDE and its electronic publication change dosage form document summary change dosage form is to improve the bioavailability of drugs to change the original dosage form of drugs (for example: from tablets to dispersible tablets, etc.) There are two main purposes to apply for the change of dosage form: one is to evade the patent of the dosage form process of the original research drug and strive to be approved and listed as soon as possible; the other is to exempt PK from the pain of bidding In order to encourage the creation of new drugs, strictly review and approve, improve the quality of drugs, and promote industrial upgrading On March 9, 2016, the State Food and Drug Administration issued a notice on the work plan for the reform of chemical drug registration and classification The announcement strictly limits the product declaration of blindly changing the dosage form in order to change the dosage form in the past, and requires that the new dosage form has obvious clinical advantages than before And change from the original 5 categories to the current 2 categories of new drugs, and apply according to the procedures of new drugs in the measures for the administration of drug registration Although, with the reform of registration and classification of chemical drugs, some changes have been made in the aspect of changing dosage forms of drugs, through the interpretation of relevant policies, regulations and guidance documents before, we can understand the change process, which has a certain reference value for later research The following is the author's input of "modifier" key words through the drug intelligence data, policies and Regulations Database (http://db.yaozh.com/policies), and the information about the modifier in CDE and its electronic publications for your reference The 46th issue of tongshuyi has come to a successful end In order to find a way out for the drugs under research, the industry's leading figures are piling up new drug policies Where is the best way to go for the drugs under research? With a series of puzzles about the future of the varieties under research, on July 9, the Forum on where to go with the varieties under research, sponsored by freehand and co organized by yaozhi.com, was officially held in Beijing Dozens of industry leaders and hundreds of people from the pharmaceutical industry gathered together, after two days of in-depth discussion and exchange, to find the best answer for the way of the drugs under research The US FDA approved Duff (0.1%) as an over-the-counter drug for acne (acne) In July 8, 2016, the US Food and Drug Administration approved OTC (Duff) (0.1%) (Adapalene Gel) for acne vulgaris 12 years of age and above, once a day for external use Daphne (0.1%) is the first over-the-counter drug for external use of retinoids to treat acne In the 1980s, Daphne was used as the first new active ingredient to treat acne Daphne (0.1%) was initially approved in 1996 as a prescription drug for acne treatment in patients over 12 years of age On July 11, 2016, xiidra, a new drug for dry eye disease, was approved by the US FDA The US Food and Drug Administration approved xiidra (lifegradast eye drops) for the treatment of dry eye disease Xiidra is a new kind of drug, which is called lymphocyte functional antigen-1 (LFA-1) antagonist Edward Cox, MD, director of the antimicrobial products office of the FDA's Center for drug evaluation and research, said, "the efficacy of standard eye drops is to clear vision and protect eye health Approval of xiidra will provide a new treatment plan for dry eye patients." What to do with the dispersible tablets under the new policy of drug registration? Key quality attributes of dispersible tablets: 1 Raw materials: insoluble (Note: microsoluble is not insoluble) 2 Clinical advantages: patient compliance, special population (such as drug use for children) 3 Dispersion uniformity research: consider setting quality standards as appropriate 4 Odor or bitterness must be corrected to improve patient compliance 5 Dissolution: as a insoluble drug, it is necessary to investigate the dissolution in various media and compare it with the original drug 6 Disintegration: < 3min zidovudine capsule - consistency evaluation of drug quality the consistency evaluation of generic drugs has entered the practical stage, and the Chinese orange peel book (folk Edition) has officially come out The author takes zidovudine capsule as an example to talk about what information the Chinese orange peel book covers Omeprazole enteric coated capsule - China orange peel book (folk Edition) is a Chinese orange peel book (folk Edition) jointly produced by yaozhi.com and tongyouyi forum What information does it cover? The author takes omeprazole enteric coated capsule as an example to talk about this orange peel book MOTU | quality consistency evaluation policy for generic drugs time axis drug declaration large household Luoxin pharmaceutical recently Luoxin pharmaceutical was founded in 1988 and listed in Hong Kong H share in 2005 It has more than 30 production lines, including powder injection, freeze-dried powder injection, water injection, solid preparation, chemical API, cephalosporin API, oral cephalosporin series products At present, the chairman of the board of directors is Liu Baoqi First quarter performance in 2016: net profit of RMB 118 million, an increase of 8.66% year on year; during the period, turnover of RMB 932 million, an increase of 20.11% year on year, a week of policy pharmaceutical enterprises, without the implementation of the two vote system, they will be kicked out of the market! In 2016, the most ruthless implementation of the provincial policy of two vote system came Yesterday (July 14), Hebei Province issued the guiding opinions on further deepening the comprehensive reform of public hospitals (hereinafter referred to as the opinions) Annual report of adverse drug reaction monitoring In order to comprehensively reflect the monitoring of adverse drug reactions in China in 2015, promote clinical rational use of drugs, and ensure the safety of public use of drugs, according to the measures for the management of adverse drug reactions report and monitoring, the State Food and Drug Administration organized the national adverse drug reactions monitoring center to compile the annual report of national adverse drug reactions monitoring (2015) The General Administration will carry out the generic drug consistency evaluation training in 7 provinces to strengthen the understanding of the personnel of drug manufacturing enterprises on the relevant policies, procedures and technical guidelines of the generic drug quality and efficacy consistency evaluation (hereinafter referred to as the generic drug consistency evaluation) and promote the smooth implementation of the generic drug consistency evaluation In the near future, the General Administration will organize some provinces and bureaus to carry out a series of training From the middle of July 2016 to the first ten days of August, training was conducted in groups in 7 provinces, namely, Zhejiang, Jiangsu, Shandong, Guangdong, Sichuan, Hebei and Heilongjiang Report the statistical table of consistency evaluation varieties before July 22 In order to thoroughly implement the spirit of the opinions of the general office of the State Council on the evaluation of the quality and efficacy of generic drugs (GBF [2016] No 8) and the announcement of the State Food and Drug Administration on the implementation of the opinions of the general office of the State Council on the evaluation of the quality and efficacy of generic drugs (2016 No 106) and other documents, and effectively promote the province's generic drugs The work of consistency evaluation of quality and efficacy (hereinafter referred to as consistency evaluation) is hereby notified as follows: 1 Fully understand the significance of consistency evaluation; 2 Improve the working mechanism; 3 Clarify the division of responsibilities; 3 Actively publicize policies; 4 Actively report and strive for various supports; 100 ° news How many do you know about the 18 uses of mifepristone? Mifepristone is a drug commonly used in obstetrics and gynecology for abortion It is called "the holy drug of abortion" Therefore, the state is very strict in management Without the prescription of a specialist, ordinary people can't get it However, in addition to abortion, it has many other magical uses, such as anti-cancer, tumor shrinking, anti depression Can also treat AIDS It's not as good as aspirin and metformin, the "magic medicine" that was stir fried a few days ago CFDA's on-site verification will attack transnational pharmaceutical enterprises again or will be shot "No one can be spared by CFDA's 100% verification of data and the way of" killing "regardless of the nature of the problem Even foreign enterprises will have problems." It is reported that since the 722 storm in 2015, nearly 80% of 1622 varieties have chosen to voluntarily withdraw and accept the fate of "disapproval" The remaining 300 or so drugs have been baptized again by the on-site verification of clinical trial data CFDA on site verification Announcement No 4 was released What will be the results of this round of verification for multinational pharmaceutical enterprises? 32 clinical trial data will be verified on site According to the requirements of the procedures for the verification of drug clinical trial data of the State Food and Drug Administration (Interim) (sfjyhg [2016] No 34), it is planned to carry out on-site verification of 32 drug clinical trial data self-examination verification varieties (see the appendix for details), such as Yanhuang burn ointment (acceptance No.: cxzs0501500), which is now publicized The publicity period is 10 working days, from July 8, 2016 to July 21, 2016 This kind of medicine has been out of use since 2016, affecting 750 million people! It is reported that since 2016, China will no longer apply for exemption from the use of medicinal freon, and will start to phase out the use of pharmaceutical inhalers with Freon ingredients From this year, China will completely stop using freon in the field of medicine, but the substance is widely used in atomized drugs It is reported that China signed relevant international agreements in 1991, promising to gradually reduce the production and use of ozone depleting substances such as Freon In order to meet the clinical medication needs of patients with asthma and chronic obstructive pulmonary disease in China, China has started the application for exemption of Freon for medical inhalation aerosol since 2009, with the exemption period from 2010 to 2015 Since 2016, China will no longer apply for exemption from the use of medical freon, and begin to phase out the use of pharmaceutical inhalers with Freon ingredients Domestic innovative drugs? According to more than 2600 yuan of price reduction for a heavyweight product of Novartis, on July 5, the terminal price of the heavyweight product of global pharmaceutical giant Novartis in China, leizhumab (nuozide), has been officially reduced from 9800 yuan / dose to 7200 yuan / dose, with a price reduction of 2600 yuan / dose, or 26% Does taking medicine work when you are ill? It's likely that you're taking the wrong "posture"! Only by taking the right medicine can we get rid of the disease! But in fact, many "bad habits" of taking medicine will also reduce the efficacy, or even increase the side effects So how to take the medicine correctly? Today, take you out of medication mistakes! In June 2016, the list of approved drug varieties was approved In June 2016, a total of 5 drug listing applications were approved, all of which were domestic chemicals Edaravone, middle / long chain fat emulsion injection (C8-24Ve), ambroxol hydrochloride and sodium chloride injection, oxygen were used respectively Original statement: This article is the original manuscript of yaozhi.com, welcome to reprint, reprint please indicate the source and author, thank you!