Business Club on March 1st According to Voice of China’s “Yangguang News†report, the “Guidelines for the Quality Control of Pharmaceutical Production (Revised in 2010)â€, which has undergone five years of revision and two public consultations, started today (March 1). Formally implemented. The State Food and Drug Administration requires that existing drug companies meet the new regulatory standards within five years, or they will stop production.
The new edition of the “Policy for the Production of Pharmaceutical Manufacturing Quality†was opened with a total of 14 chapters and 313 articles. Compared with the 1998 edition, the number of articles has increased considerably. Starting from today, newly-built pharmaceutical production companies and pharmaceutical production companies newly build, or renovate and expand the workshops, all must meet the requirements of the "Plant Production Quality Control Regulations." The production of aseptic products such as blood products and vaccine injections of existing drug manufacturers should meet the requirements of the "Quality Control Practice for Pharmaceutical Production" before December 31, 2013. The production of other types of drugs should be completed in 2015.12 By the 31st of the month, the "Manufacturing Quality Control Standard for Pharmaceuticals" has been met. Any company or workshop that does not meet the requirements will not be allowed to continue producing drugs after the above-mentioned deadline. To this end, Sun Xianze, Director of the Safety and Supervision Department of the State Food and Drug Administration briefly introduced us to the main contents of the increase.
Sun Xianze: The new version of drug GMP has raised the requirements for key personnel qualifications in terms of academic qualifications, technical titles, work experience, etc., increased the requirements for enterprises to establish a quality management system, increased the standards of some production conditions, and built up quality risk management. A series of new systems have prompted manufacturers to discover in time the unsafe factors that affect the quality of drugs and take the initiative to prevent the occurrence of quality accidents.
Wu Changhai, general manager of Guangzhou Pharmaceuticals, the largest manufacturer of Chinese patent medicines in China, said that the new pharmaceutical production quality management specification will indeed bring about an increase in cost pressures. He said that the improvement of standards has become more and more demanding for enterprises. However, this is not only a requirement of national policies, but also a requirement that companies must meet in the face of market competition. He said that the pressures on all aspects of costs, equipment costs, and personnel costs have increased, but he also mentioned that before the new regulations were introduced, they had already carried out the production site, the environment, and equipment reconstruction and technological transformation. With the preparation in advance, the newly released standards will not only affect large companies such as Guangzhou Pharmaceutical.
According to Wang Bo, deputy director of the Chinese Pharmaceutical Enterprises Management Association, he said that all companies will have an impact, but different companies have different coping capabilities. This time raising pharmaceutical standards is not only for people who can enjoy higher quality medicines. It is also to improve the structure of the pharmaceutical industry in China. Wang Bo said that in order to raise standards, some enterprises that have a large gap with this standard will not have core competitiveness in the future competition and will naturally retreat from their difficulties and fade out of the pharmaceutical manufacturing industry.
This is a high-risk, high-return, high-investment industry. At present, there are 4,800 such enterprises in China, and the general scale is relatively small. This will lead to a lot of non-benign competition, and some small pharmaceutical companies will gradually fade out. The stage of history. To achieve the new version of the standard, it is expected that each company will invest 5-10 million yuan, eating almost one to two years of net profit. At present, domestic pharmaceutical companies have operating income of less than 50 million yuan and accounting for more than 70%. The annual net profit of most small and medium-sized enterprises is about 1,000 to 20 million. The profits of these companies are only worth 10 million yuan. cost of. The State Food and Drug Administration predicts that 500 companies will be eliminated because of the approval of this regulation. However, there are currently 900 pharmaceutical companies that are already at a loss, so the actual number of companies that have been eliminated may exceed 1,000.
The new edition of the “Policy for the Production of Pharmaceutical Manufacturing Quality†was opened with a total of 14 chapters and 313 articles. Compared with the 1998 edition, the number of articles has increased considerably. Starting from today, newly-built pharmaceutical production companies and pharmaceutical production companies newly build, or renovate and expand the workshops, all must meet the requirements of the "Plant Production Quality Control Regulations." The production of aseptic products such as blood products and vaccine injections of existing drug manufacturers should meet the requirements of the "Quality Control Practice for Pharmaceutical Production" before December 31, 2013. The production of other types of drugs should be completed in 2015.12 By the 31st of the month, the "Manufacturing Quality Control Standard for Pharmaceuticals" has been met. Any company or workshop that does not meet the requirements will not be allowed to continue producing drugs after the above-mentioned deadline. To this end, Sun Xianze, Director of the Safety and Supervision Department of the State Food and Drug Administration briefly introduced us to the main contents of the increase.
Sun Xianze: The new version of drug GMP has raised the requirements for key personnel qualifications in terms of academic qualifications, technical titles, work experience, etc., increased the requirements for enterprises to establish a quality management system, increased the standards of some production conditions, and built up quality risk management. A series of new systems have prompted manufacturers to discover in time the unsafe factors that affect the quality of drugs and take the initiative to prevent the occurrence of quality accidents.
Wu Changhai, general manager of Guangzhou Pharmaceuticals, the largest manufacturer of Chinese patent medicines in China, said that the new pharmaceutical production quality management specification will indeed bring about an increase in cost pressures. He said that the improvement of standards has become more and more demanding for enterprises. However, this is not only a requirement of national policies, but also a requirement that companies must meet in the face of market competition. He said that the pressures on all aspects of costs, equipment costs, and personnel costs have increased, but he also mentioned that before the new regulations were introduced, they had already carried out the production site, the environment, and equipment reconstruction and technological transformation. With the preparation in advance, the newly released standards will not only affect large companies such as Guangzhou Pharmaceutical.
According to Wang Bo, deputy director of the Chinese Pharmaceutical Enterprises Management Association, he said that all companies will have an impact, but different companies have different coping capabilities. This time raising pharmaceutical standards is not only for people who can enjoy higher quality medicines. It is also to improve the structure of the pharmaceutical industry in China. Wang Bo said that in order to raise standards, some enterprises that have a large gap with this standard will not have core competitiveness in the future competition and will naturally retreat from their difficulties and fade out of the pharmaceutical manufacturing industry.
This is a high-risk, high-return, high-investment industry. At present, there are 4,800 such enterprises in China, and the general scale is relatively small. This will lead to a lot of non-benign competition, and some small pharmaceutical companies will gradually fade out. The stage of history. To achieve the new version of the standard, it is expected that each company will invest 5-10 million yuan, eating almost one to two years of net profit. At present, domestic pharmaceutical companies have operating income of less than 50 million yuan and accounting for more than 70%. The annual net profit of most small and medium-sized enterprises is about 1,000 to 20 million. The profits of these companies are only worth 10 million yuan. cost of. The State Food and Drug Administration predicts that 500 companies will be eliminated because of the approval of this regulation. However, there are currently 900 pharmaceutical companies that are already at a loss, so the actual number of companies that have been eliminated may exceed 1,000.
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