Yin Li, director of the State Food and Drug Administration of China, said in an interview with Xinhua News Agency on the 3rd that after the issue of excessive chromium capsules appeared, it was necessary to take active measures to “catch fireâ€, but it was more important to improve relevant systems and regulations from the source. "Fire protection". The "Regulations on Strengthening the Supervision and Administration of Pharmaceutical Excipients" recently launched is one of the "fire prevention" measures.
Yin Li said that according to the "Drug Administration Law," pharmaceutical excipients refer to the excipients and additives used in the production of pharmaceuticals and prescriptions. In layman's terms, pharmaceutical excipients are the generic term for other ingredients in a medicine other than active ingredients.
He said that China's management of pharmaceutical excipients has also undergone a process of gradual strengthening and gradual standardization. Although the regulatory authorities made some efforts, there are still some problems in the management of pharmaceutical excipients. The recent capsule incident also revealed problems in the production and use of pharmaceutical excipients in China.
In order to further strengthen the management of pharmaceutical excipients and plug the loopholes in the production and use management of pharmaceutical excipients, the State Food and Drug Administration drafted the “Regulations on Strengthening Supervision and Administration of Pharmaceutical Excipientsâ€.
Yin Li introduced that the new regulations mainly include the following measures: First, the implementation of regulatory responsibilities, with emphasis on the supervision of the entire process of drug production. The second is to improve access thresholds. At the same time, in order to facilitate the regulatory authorities to fully understand the situation of excipients, the State Bureau will establish a database of pharmaceutical excipients.
Yin Li said that the introduction of the regulations will impose stricter regulatory requirements on the practice of the pharmaceutical excipient industry. Implementation on February 1 next year will further clean up the industry.
The regulations increase the standards and thresholds of pharmaceutical excipients. The current version of the 2010 edition of the Chinese Pharmacopoeia contains 132 standards for excipient products. Although it has doubled the 2005 edition of the pharmacopoeia, it still cannot completely cover the products on the market today. The National Bureau is organizing the Pharmacopoeia Committee to further develop the revision of the standards for pharmaceutical excipients. It is hoped that the 2015 edition of the Pharmacopoeia will be doubled again to reach the standard of 300 excipients.
He said that the improvement of the quality standards for entry barriers and excipients for pharmaceutical excipient manufacturing enterprises will inevitably lead to the withdrawal of some unqualified and non-standard pharmaceutical excipient production enterprises from the market, the market environment will be purified, and the degree of industrial concentration will be further improved. This will help advantage companies stand out.
On the other hand, as a person responsible for the quality of pharmaceuticals, pharmaceutical preparation enterprises will pay more attention to the quality of the upstream suppliers, and will consciously go on importing well, which will help improve the quality of medicines.
Yin Li said that according to the "Drug Administration Law," pharmaceutical excipients refer to the excipients and additives used in the production of pharmaceuticals and prescriptions. In layman's terms, pharmaceutical excipients are the generic term for other ingredients in a medicine other than active ingredients.
He said that China's management of pharmaceutical excipients has also undergone a process of gradual strengthening and gradual standardization. Although the regulatory authorities made some efforts, there are still some problems in the management of pharmaceutical excipients. The recent capsule incident also revealed problems in the production and use of pharmaceutical excipients in China.
In order to further strengthen the management of pharmaceutical excipients and plug the loopholes in the production and use management of pharmaceutical excipients, the State Food and Drug Administration drafted the “Regulations on Strengthening Supervision and Administration of Pharmaceutical Excipientsâ€.
Yin Li introduced that the new regulations mainly include the following measures: First, the implementation of regulatory responsibilities, with emphasis on the supervision of the entire process of drug production. The second is to improve access thresholds. At the same time, in order to facilitate the regulatory authorities to fully understand the situation of excipients, the State Bureau will establish a database of pharmaceutical excipients.
Yin Li said that the introduction of the regulations will impose stricter regulatory requirements on the practice of the pharmaceutical excipient industry. Implementation on February 1 next year will further clean up the industry.
The regulations increase the standards and thresholds of pharmaceutical excipients. The current version of the 2010 edition of the Chinese Pharmacopoeia contains 132 standards for excipient products. Although it has doubled the 2005 edition of the pharmacopoeia, it still cannot completely cover the products on the market today. The National Bureau is organizing the Pharmacopoeia Committee to further develop the revision of the standards for pharmaceutical excipients. It is hoped that the 2015 edition of the Pharmacopoeia will be doubled again to reach the standard of 300 excipients.
He said that the improvement of the quality standards for entry barriers and excipients for pharmaceutical excipient manufacturing enterprises will inevitably lead to the withdrawal of some unqualified and non-standard pharmaceutical excipient production enterprises from the market, the market environment will be purified, and the degree of industrial concentration will be further improved. This will help advantage companies stand out.
On the other hand, as a person responsible for the quality of pharmaceuticals, pharmaceutical preparation enterprises will pay more attention to the quality of the upstream suppliers, and will consciously go on importing well, which will help improve the quality of medicines.
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