Business News Agency On November 17th, at the 65th API China held for three days, the major forums discussed national basic electronic drug regulatory systems, new editions of the Chinese Pharmacopoeia and sewage disposal policies and standards.
The 65th API China fell behind in Suzhou. "Pharmaceutical Economic News" reporter found at the exhibition site, this API China special set up the pharmaceutical raw materials area, packaging and production equipment joint exhibition area, pharmaceutical electronic regulatory area and the new GMP exhibition area and other four exhibition areas. Among them, the exhibitors of the raw material medicine exhibition area still maintained a scale of more than 1,000, and the display scale of the pharmaceutical auxiliary material area was further expanded.
In addition, the appearance of brand companies frequently appears in the exhibition and major forums. In major forums, new policies such as the national electronic monitoring system for essential medicines, the new edition of the "Chinese Pharmacopoeia", and the "Drainage Standards for Water Pollutants for the Pharmaceutical Industry" were mentioned and discussed most frequently, showing that companies and industries are competing with each other and developing. And policy attention.
Focus One: Overall Solution for Electronic Supervision
The State Food and Drug Administration will, starting March 31, 2011, implement electronic supervision of the varieties listed in the Essential Drug List. Drug manufacturers need to do a lot of work, including drug coding, transformation of production lines, and transformation of finished product warehouses. The reporter learned that how to assign the code and which method is cheaper has become the focus of the company.
In the pharmaceutical equipment area, a pharmaceutical electronics regulatory sub-district was subdivided, and a large number of packaging, printing, labeling, and information management systems companies were concentrated. The organizer drew a warm slogan “Here, let Domino design the system integration for you, let Fangzheng be your coding equipment supplier, and let Kodak provide you with printing equipment.†This area attracts a lot of audience. .
In the case of drug electronic regulatory demonstrations, more than a dozen companies focused on demonstrating electronic surveillance code system solutions in one and a half days. For the informationization of electronic supervision that must be realized in a short period of time, the efficiency, effectiveness, and integration with the existing system are of particular concern to the company. Therefore, the overall solution is highly sought after at the show.
Focus 2: Excipient management under the new standard
The new version of the Pharmacopoeia has been officially implemented for more than a month. Although the relevant discussions have been very thorough, the new edition of the Pharmacopoeia remains one of the hot topics in the pharmaceutical excipients industry.
The revision of the new edition of the Pharmacopoeia added “General Rules for Pharmaceutical Excipientsâ€, emphasizing the role and safety of medicinal excipients, and at the same time improved the standard of capsules, involving gelatin hollow capsules, enteric gelatin hollow capsules, gelatin capsules, not only gelatin The production of raw materials used in hollow capsule production sets a standard, and it also sets safety limits for its quality, and the indicators are relatively strict.
In this regard, the China Pharmaceutical Packaging Association Hollow Capsule Professional Committee specially organizes a forum to discuss the possible impact of the new Pharmacopoeia on the hollow capsule industry. Zhang Shide, chairman of Qingdao Yiqing Capsule Co., Ltd., believes that the introduction of new standards will certainly accelerate the concentration and reshuffle of the industry. In particular, the detection of chromium will block enterprises that use low-quality gelatin to produce capsules, which is beneficial to purification. Industrial environment.
The other major focus of discussion on pharmaceutical excipients has focused on the DMF filing system that has completed consultations. Domestic and imported accessories companies such as Sanhe Pharmaceuticals, Iowa Pharmaceuticals, and JRS have appeared in the “high-end salon for the development of pharmaceutical excipients industry†and discussed with experts “third-party auditing†and whether “the DMF system will be in parallel with the registration system. Period" and other topics. Experts stated that third-party auditing is an internationally accepted form of auditing and that it is not possible to exclude third-party audits in the future. At the same time, Tu Jiasheng, a member of the China Pharmacopoeia Committee and a professor at the China Pharmaceutical University, reminded that the regulatory agency may start implementing the DMF system from newly registered drugs, that is, the new materials used for the registration of pharmaceutical excipients must have a DMF filing number, otherwise it will not be approved from this perspective. In terms of the above, pharmaceutical excipient manufacturers should file their records as soon as possible.
Focus three: the high end of the package material
With the development of the industry and the importance attached by brand enterprises to pharmaceutical packaging materials, more and more pharmaceutical companies have begun to adopt high-quality packaging materials, which has promoted the development of high-end packaging materials. This year, more than 300 companies such as Rosello gelatin, Suzhou capsules, Hubei Huaqiang, and Ningbo Zhengli have gathered in the exhibition area of ​​pharmaceutical packaging materials. The contents of the exhibition included rubber plugs, capsules, glass, plastics, and aluminum foil. The scale is higher than the previous one.
In the glass packaging exhibition area, the person in charge of an exhibitor told reporters that he believes that China is the fastest growing region in Asia, and that the development of high-end control products is also very fast, not only that the company's high-end product market sales are expected to be higher than this year. Doubled last year, and more and more companies have started to introduce high-end varieties, which are inextricably linked to the booming demand for endogenous demand in the Chinese pharmaceutical market.
The 65th API China fell behind in Suzhou. "Pharmaceutical Economic News" reporter found at the exhibition site, this API China special set up the pharmaceutical raw materials area, packaging and production equipment joint exhibition area, pharmaceutical electronic regulatory area and the new GMP exhibition area and other four exhibition areas. Among them, the exhibitors of the raw material medicine exhibition area still maintained a scale of more than 1,000, and the display scale of the pharmaceutical auxiliary material area was further expanded.
In addition, the appearance of brand companies frequently appears in the exhibition and major forums. In major forums, new policies such as the national electronic monitoring system for essential medicines, the new edition of the "Chinese Pharmacopoeia", and the "Drainage Standards for Water Pollutants for the Pharmaceutical Industry" were mentioned and discussed most frequently, showing that companies and industries are competing with each other and developing. And policy attention.
Focus One: Overall Solution for Electronic Supervision
The State Food and Drug Administration will, starting March 31, 2011, implement electronic supervision of the varieties listed in the Essential Drug List. Drug manufacturers need to do a lot of work, including drug coding, transformation of production lines, and transformation of finished product warehouses. The reporter learned that how to assign the code and which method is cheaper has become the focus of the company.
In the pharmaceutical equipment area, a pharmaceutical electronics regulatory sub-district was subdivided, and a large number of packaging, printing, labeling, and information management systems companies were concentrated. The organizer drew a warm slogan “Here, let Domino design the system integration for you, let Fangzheng be your coding equipment supplier, and let Kodak provide you with printing equipment.†This area attracts a lot of audience. .
In the case of drug electronic regulatory demonstrations, more than a dozen companies focused on demonstrating electronic surveillance code system solutions in one and a half days. For the informationization of electronic supervision that must be realized in a short period of time, the efficiency, effectiveness, and integration with the existing system are of particular concern to the company. Therefore, the overall solution is highly sought after at the show.
Focus 2: Excipient management under the new standard
The new version of the Pharmacopoeia has been officially implemented for more than a month. Although the relevant discussions have been very thorough, the new edition of the Pharmacopoeia remains one of the hot topics in the pharmaceutical excipients industry.
The revision of the new edition of the Pharmacopoeia added “General Rules for Pharmaceutical Excipientsâ€, emphasizing the role and safety of medicinal excipients, and at the same time improved the standard of capsules, involving gelatin hollow capsules, enteric gelatin hollow capsules, gelatin capsules, not only gelatin The production of raw materials used in hollow capsule production sets a standard, and it also sets safety limits for its quality, and the indicators are relatively strict.
In this regard, the China Pharmaceutical Packaging Association Hollow Capsule Professional Committee specially organizes a forum to discuss the possible impact of the new Pharmacopoeia on the hollow capsule industry. Zhang Shide, chairman of Qingdao Yiqing Capsule Co., Ltd., believes that the introduction of new standards will certainly accelerate the concentration and reshuffle of the industry. In particular, the detection of chromium will block enterprises that use low-quality gelatin to produce capsules, which is beneficial to purification. Industrial environment.
The other major focus of discussion on pharmaceutical excipients has focused on the DMF filing system that has completed consultations. Domestic and imported accessories companies such as Sanhe Pharmaceuticals, Iowa Pharmaceuticals, and JRS have appeared in the “high-end salon for the development of pharmaceutical excipients industry†and discussed with experts “third-party auditing†and whether “the DMF system will be in parallel with the registration system. Period" and other topics. Experts stated that third-party auditing is an internationally accepted form of auditing and that it is not possible to exclude third-party audits in the future. At the same time, Tu Jiasheng, a member of the China Pharmacopoeia Committee and a professor at the China Pharmaceutical University, reminded that the regulatory agency may start implementing the DMF system from newly registered drugs, that is, the new materials used for the registration of pharmaceutical excipients must have a DMF filing number, otherwise it will not be approved from this perspective. In terms of the above, pharmaceutical excipient manufacturers should file their records as soon as possible.
Focus three: the high end of the package material
With the development of the industry and the importance attached by brand enterprises to pharmaceutical packaging materials, more and more pharmaceutical companies have begun to adopt high-quality packaging materials, which has promoted the development of high-end packaging materials. This year, more than 300 companies such as Rosello gelatin, Suzhou capsules, Hubei Huaqiang, and Ningbo Zhengli have gathered in the exhibition area of ​​pharmaceutical packaging materials. The contents of the exhibition included rubber plugs, capsules, glass, plastics, and aluminum foil. The scale is higher than the previous one.
In the glass packaging exhibition area, the person in charge of an exhibitor told reporters that he believes that China is the fastest growing region in Asia, and that the development of high-end control products is also very fast, not only that the company's high-end product market sales are expected to be higher than this year. Doubled last year, and more and more companies have started to introduce high-end varieties, which are inextricably linked to the booming demand for endogenous demand in the Chinese pharmaceutical market.
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