Recently, the State Food and Drug Administration issued the "Relevant Regulations for Strengthening the Supervision and Administration of Pharmaceutical Excipients (Draft for Solicitation of Comments)" (hereinafter referred to as the "Draft for Comment"), and publicly solicited opinions from the public. It is planned to be officially implemented on October 1 this year. It is reported that the State Food and Drug Administration will adopt a combination of punches to achieve the management of further strict production and use of medicinal excipients, including “to further implement the responsibility of pharmaceutical production companies and the responsibility of regulatory authoritiesâ€, “implement GMP, carry out classified management and associate with pharmaceutical preparations. Review to improve the access threshold for medicinal excipients, and “strengthen the crackdown to deter violations of laws and regulationsâ€.
The cost of entry barriers and violations will increase "After the implementation of the new regulations, at least 50% of pharmaceutical excipients in China will need to be supervised. More than 200 varieties are included in the new national pharmacopoeia. According to the plan, the 2015 edition of the Pharmacopoeia for pharmaceutical excipients The collection will at least double compared to the present," said Shi Yongjun, head of the International Pharmaceutical Accessories Network. According to statistics from a non-official website, only 30% to 40% of pharmaceutical excipients are currently included in drug administration. According to the “Draft for Comments,†thousands of pharmaceutical excipients in China will be managed with reference to APIs. This will have a painful period for the accessories industry in the short term.
“Pharmaceutical excipients production enterprises will be required to organize production in accordance with the requirements of the “Quality Control Specification for Pharmaceutical Excipients Productionâ€. At the same time, the practice of classifying and managing supplementary materials according to the risk level will also raise the bar for high-risk excipients companies. The increase in the above two thresholds will take away some of the companies that originally produced pharmaceutical excipients with food grade and chemical grade standards, said Shi Yongjun. In addition, new regulations concerning the evaluation of new medicinal excipients and pharmaceutical preparations, as well as a series of practices that emphasize drug manufacturers' inspection and audit responsibilities for new excipients, will drive most non-quality-oriented excipient companies out of the market.
In accordance with the theory of cost transfer, the supervision of pharmaceutical excipients will inevitably lead to the downstream pharmaceutical industry. According to industry companies, after the issue of chromium exceeds standards, the relevant departments also hope to wash out the non-standard enterprises in the pharmaceutical industry. For these non-standard enterprises, the closing of the closed doors has become a more general view of regulators.
According to the new regulations, pharmaceutical preparation companies, who are responsible for drug quality, must strictly control the use of excipients for the production of drugs and conduct audits of suppliers. Purchased pharmaceutical excipients must be tested in accordance with the standard before being used for pharmaceutical production. “Intensifying the supervision of upstream excipients will definitely have an impact on the downstream pharmaceutical companies. In the event that costs continue to increase, tendering 'only low prices is to take' will encounter more challenges.†A Shanghai pharmaceutical Senior industry experts recommend that the government should consider the increased cost of the company while strengthening supervision, and give differential pricing to companies that strictly follow the new regulations for production.
Fixed-point production or due to depleting food At the same time, according to Zhang Shide, vice president of the China Pharmaceutical Packaging Association, the relevant person of the Ministry of Health of the Ministry of Health hopes to discuss the hollow capsules needed for the solid preparations of Jiyue capsules, which will be produced by certain designated enterprises, so that the capsule quality Or easier to control.
It is understood that in foreign countries, the quality of gelatin is the responsibility of the enterprises that produce gelatin. When foreign pharmaceutical preparation companies select gelatin raw materials, they must audit the source of raw materials, production techniques, and quality inspections of gelatin production companies, and purchase them when they meet the requirements of the pharmaceutical products produced by the company. The EU's gelatin standard specifies a chromium limit of 10 ppm (safety level limit), and the United States does not even set a limit for chromium in the gelatin quality standard. Countries such as Europe and the United States are adopting a combination of high self-discipline and strict supervision in this regard.
In China, the sales volume of capsule solid preparations entering the base medicine list is about 50 billion tablets each year. According to the traditional view, the quality of something produced by a fixed-point company may be better than that of a variety of manufacturers on the market. According to Zhang Shide, the enhancement of industry self-discipline and the improvement of product safety all provide a realistic basis for the fixed-point production of capsules.
However, there are people in the industry who have different opinions. Shi Lichen, a partner of the Beijing University’s vertical and horizontal medicine division, stated that fixed-point production means that there is power to rent space, which is not very meaningful. This deprives the base drug manufacturer of the right to purchase on its own, and may also add a new cost burden to the manufacturer. He believes that fixed-point production is like abolishing food and strengthening supervision is the right way.
The cost of entry barriers and violations will increase "After the implementation of the new regulations, at least 50% of pharmaceutical excipients in China will need to be supervised. More than 200 varieties are included in the new national pharmacopoeia. According to the plan, the 2015 edition of the Pharmacopoeia for pharmaceutical excipients The collection will at least double compared to the present," said Shi Yongjun, head of the International Pharmaceutical Accessories Network. According to statistics from a non-official website, only 30% to 40% of pharmaceutical excipients are currently included in drug administration. According to the “Draft for Comments,†thousands of pharmaceutical excipients in China will be managed with reference to APIs. This will have a painful period for the accessories industry in the short term.
“Pharmaceutical excipients production enterprises will be required to organize production in accordance with the requirements of the “Quality Control Specification for Pharmaceutical Excipients Productionâ€. At the same time, the practice of classifying and managing supplementary materials according to the risk level will also raise the bar for high-risk excipients companies. The increase in the above two thresholds will take away some of the companies that originally produced pharmaceutical excipients with food grade and chemical grade standards, said Shi Yongjun. In addition, new regulations concerning the evaluation of new medicinal excipients and pharmaceutical preparations, as well as a series of practices that emphasize drug manufacturers' inspection and audit responsibilities for new excipients, will drive most non-quality-oriented excipient companies out of the market.
In accordance with the theory of cost transfer, the supervision of pharmaceutical excipients will inevitably lead to the downstream pharmaceutical industry. According to industry companies, after the issue of chromium exceeds standards, the relevant departments also hope to wash out the non-standard enterprises in the pharmaceutical industry. For these non-standard enterprises, the closing of the closed doors has become a more general view of regulators.
According to the new regulations, pharmaceutical preparation companies, who are responsible for drug quality, must strictly control the use of excipients for the production of drugs and conduct audits of suppliers. Purchased pharmaceutical excipients must be tested in accordance with the standard before being used for pharmaceutical production. “Intensifying the supervision of upstream excipients will definitely have an impact on the downstream pharmaceutical companies. In the event that costs continue to increase, tendering 'only low prices is to take' will encounter more challenges.†A Shanghai pharmaceutical Senior industry experts recommend that the government should consider the increased cost of the company while strengthening supervision, and give differential pricing to companies that strictly follow the new regulations for production.
Fixed-point production or due to depleting food At the same time, according to Zhang Shide, vice president of the China Pharmaceutical Packaging Association, the relevant person of the Ministry of Health of the Ministry of Health hopes to discuss the hollow capsules needed for the solid preparations of Jiyue capsules, which will be produced by certain designated enterprises, so that the capsule quality Or easier to control.
It is understood that in foreign countries, the quality of gelatin is the responsibility of the enterprises that produce gelatin. When foreign pharmaceutical preparation companies select gelatin raw materials, they must audit the source of raw materials, production techniques, and quality inspections of gelatin production companies, and purchase them when they meet the requirements of the pharmaceutical products produced by the company. The EU's gelatin standard specifies a chromium limit of 10 ppm (safety level limit), and the United States does not even set a limit for chromium in the gelatin quality standard. Countries such as Europe and the United States are adopting a combination of high self-discipline and strict supervision in this regard.
In China, the sales volume of capsule solid preparations entering the base medicine list is about 50 billion tablets each year. According to the traditional view, the quality of something produced by a fixed-point company may be better than that of a variety of manufacturers on the market. According to Zhang Shide, the enhancement of industry self-discipline and the improvement of product safety all provide a realistic basis for the fixed-point production of capsules.
However, there are people in the industry who have different opinions. Shi Lichen, a partner of the Beijing University’s vertical and horizontal medicine division, stated that fixed-point production means that there is power to rent space, which is not very meaningful. This deprives the base drug manufacturer of the right to purchase on its own, and may also add a new cost burden to the manufacturer. He believes that fixed-point production is like abolishing food and strengthening supervision is the right way.
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