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| It's about survival! Pharmaceutical companies should carry out process change research as soon as possible |
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| Author：中国铭铉 企划部 Release Time：2017-9-20 10:19:39 Number Browse：1029 |
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On September 11, September 11, the CFDA issued a circular on the guidelines for the study of the technical changes in the production process of traditional Chinese medicine (hereinafter referred to as "official draft"). Before the release of the official Chinese medicine, the CFDA issued the guidelines on the technical guidelines for the study of the chemical production process change of listed chemicals on August 29. On September 7, CDE began online solicitation of the guidelines on the guiding principles of post-marketing change in biological products.
Thus, the technical guiding principle of the technological change of three types of drugs is expected to be released in 2017. With the release of the guiding principles of process change, CFDA has a theoretical basis. The flying inspection of process check is related to the survival of the enterprise, so the production enterprises should carry out the process change study as soon as possible.
The process change test has begun
On August 9, 2016 CFDA open for carry out the work of pharmaceutical production process to check on the announcement (draft) ", originally scheduled for September 10, 2016 amendments solicitation, pharmaceutical production enterprise in October 1, 2016 to complete the check list and introspects to local food and drug supervision department at the provincial level. Provincial-level food and drug regulatory authorities shall summarize the situation of self-inspection by enterprises, fill in the summary table of the situation and report to the general administration of food and drug administration before November 1, 2016.
According to the draft, the pharmaceutical producing enterprises shall be completed before June 30, 2017 in the product of production technology research and validation, is inconsistent with the actual production technology and production processes approved submit supplementary application and so on related work, no other products should be completed before December 31, 2017 the work; On June 30, 2017, the production will not be completed on time.
Moreover, from November 1, 2016, CFDA will organize experts to carry out flying tests on the production process of drug manufacturers. As shown in table 1, CFDA has already begun inspecting the process in December 2016.
In December 2016, 9-11, accept inspection of sichuan plateau pearl pharmaceutical co., LTD as an example, the CFDA announcement this enterprise compound radix isatidis granule production batch bag change from 50000 to 50000 bags, extraction equipment changes before use 1 extraction tank, currently use 4 extraction tank production, not to change control, and not to change the batch for risk assessment and process validation. Thus, process change has been one of the contents of CFDA's flying inspection program.
Nine different details of the Chinese medicine "official draft"
In March 2017, the CDE website issued a notice concerning the guidelines for the technical guidance of the study on the production process change of listed Chinese medicine production. (hereinafter referred to as "draft for comment". The comparison between the "solicitation draft" and the newly released "official draft" is found in the comparison between the "solicitation draft" and the "official draft" which has just been released. The findings are made in the following nine details.
1. The applicant has carried out research on the proposed change of the production process of the listed Chinese medicine, and the "supplemental application" to the pharmaceutical supervisory and administrative departments is deleted.
Acknowledge process change to better quality. "Formal" request ", no matter what kind of change should not drug safety and efficacy of negative effect ", "draft" is "do not allow the security, effectiveness significantly change".
Three Chinese traditional medicine production process change the quality of research methods, for example, in addition to the "draft" mentioned in the fingerprint (feature maps) and dissolution test, "a formal draft" increase biological activity test. Chinese traditional medicine production process change research and declare the information requirements of Ⅰ class changes "quality contrast research", "official draft" also increased biological activity test.
More than 4 research validation samples from "the pilot scale" to "to represent the actual production situation," Chinese traditional medicine production process change research and declare the information requirements of Ⅰ class changes to the requirement of the pilot production data from "pilot study data provide 3 batches of stable" to "provide 3 batch to represent actual production situation of the pilot study data".
This is in line with the current trend of registration of new chemicals, for example, which requires the production process to be produced in the largest quantities at present.
Classification of five herbs to handle change before Ⅰ class changes to remove the "excluding heat-sensitive, volatile constituents of medicinal herbs or increase the second-stage instant high temperature sterilization processing steps".
Classification of the extraction and purification of six changes Ⅰ class changes "let stand, filtration of liquids" instead of centrifugal; The "fixate content of the liquid in the liquid" was changed to "liquid drug solution", and the filter was changed to centrifuge (or centrifuge changed to liquid solution and filtration). "The contents of the solid and indicator elements in the liquid are unchanged", and the "official draft" is required to change the content of the index.
Molding process change classification Ⅰ class changes, to increase average filtering process of liquids, or change of solution of ordinary filter material, aperture and the filter material number of filtration process, such as "formal draft" also new request "related detection and solids, index content unchanged".
7 molding process change classification Ⅲ class changes, "a formal draft" will "to the drug had significant effect on the physical and chemical properties, such as methods of molding process of change" instead of "have obvious effects on drug absorption by using methods of molding process of change", and more focused on pharmacokinetics related content.
8 molding process change classification Ⅲ class changes, the "formal" delete "slow release/controlled release preparations slow-release material type or amount of change".
Chinese traditional medicine production process change research and declare the information requirements of Ⅲ class changes, delete "slow release/controlled release preparation materials as part of the Ⅲ change change should provide pharmacokinetic research materials" and "external preparation materials as part of the Ⅲ change change, drug non-clinical safety for" two content.
9 Chinese medicine production process change research and declare the information requirements of Ⅱ class changes, clinical trials or bioequivalence study comparing data formal draft out "some clinical trials in the number of cases of not less than 100 for clinical trials, used in a number of diseases, every major disease cases of not less than 60 to" clinical trials of restrictions.
Which enterprises make process change record?
As of September 13, 2016, there are 74 supplementary applications for process change related to process change. 74 basically are the production process change that does not change the product quality to submit the application for filing.
On the record, 73 belong to chongqing food and drug administration, and 1 belongs to the food and drug administration of shaanxi province. Chongqing technology changes the supplement for the record number of rank first, because of chongqing in March, 2016 issued "the food and drug administration in chongqing on strengthening production technology and prescription drug cleanup supplementary notice (chongqing food drug safety production [2016] no. 14). Pharmaceutical production enterprise application for no change in the quality difference after chongqing pharmaceutical technology review certification center to declare information examination and approval, the changes will not affect the internal quality of products, can be put on record.
The production enterprise must also be the top three companies in chongqing. Fuan pharmaceutical co., which has the largest number of bugle calls, has 37. Second, tiansan pharmaceutical, 32, chongqing saiwei pharmaceutical co., LTD.
In terms of drug classification, 72 chemical processes, biological products and 1 Chinese medicine. The products of chemical change are mainly used for injection of antibiotics and raw materials. The biological products change process is the casinol live bacteria capsule, the traditional Chinese medicine is the dehumidifying analgesic capsule.
Summary < < <
From chongqing data can be speculated that each enterprise on the declaration process changes, mainly "does not change the production process of product quality for the record the supplement", some of the more mature technology injection is expected to more easily approved for the record.
Since the 2016 clinical examination and verification, a large number of declarations have been withdrawn, and individual enterprises have been a little bit of a threat to the application of the process verification, for fear that they will be accounted for after the autumn. After all, the clinical self-check verification is a setback for the enterprise for the new product development. The conformance evaluation can be regarded as the restriction of the products in the procurement channel of medical institutions; Process check is the battle of survival for enterprises, once the flight inspection cannot pass, the original products may be discontinued do process change research, GMP certificate and cancelled the risk of enterprise does not value?
With the release of the guiding principle of process change, it provides a theoretical basis for CFDA flying inspection. The production enterprises should carry out the study of process change as soon as possible.
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