Medical network on April 7 - just released by the quality of generic drugs and curative effect of consistency evaluation guidance of category of varieties no. 49 (2017) "is to say, its purpose is to promote domestic enterprises to evaluate consistency as soon as possible, also means that generic pattern will be good in product quality first. 

 

"The 289 varieties" competition has begun 

 

Released on November 29, 2016, the CFDA "open for generic drugs quality consistency and efficacy evaluation variety classification guidance opinion" (hereinafter referred to as "draft"), after four months in April 5, 2017, has finally released the generic quality consistency and efficacy evaluation varieties classification guidance "of the announcement no. 49 (2017)" (hereinafter referred to as "at the end of the notice"). 

 

Relative to the "draft" in 2018 by the end of complete consistency evaluation of the classification of the varieties of "289" do, "at the end of the notice" is for all chemical medicine classification of generic drugs. This indicates that the quality of generic drugs and curative effect of consistency evaluation guidance of category of varieties have universality. Also suggested that "the 289 varieties" although not a national focus on current products, but from the national level, administration of enterprises are encouraged to start generics consistency evaluation of all products. 

 

Thus, in order to occupy the competitive advantage, interested in taking market potential of larger "variety" 289 manufacturers, don't wait any longer. In fact, there have been a lot of companies are quietly to carry out consistency evaluation. Salty reach data V3.2 found that BE records starts, in the clinical trial data open to start the clinical trial registration number article 58. BE clinical start just BE put on record, as part of the product can start clinical and BE clinical institutions to undertake project number have a certain correlation, given the current BE willing to undertake projects clinical agencies have full state, is expected to more than present actual BE put on record the number of open data. 

 

From table 1 can BE seen, BE put on record after the start of clinical's most competitive product is temporarily for Greg lowe and he dara not pills. Clinical trials is already available in the "289 catalog" BE launched 11 products, accounts for only 3.8% of the total number of varieties. The 11 varieties are lamivudine tablets, acarbose tablets, clopidogrel bisulfate tablet and cefuroxime ester tablets, ibuprofen sustained release capsule, maleic acid enalaprilat slice, benzene sulfonic acid amlodipine, Glenn urea pills, azithromycin capsule, amoxicillin capsules and captopril tablets. 

 

Table 1 has BE the start of the clinical record products 

 

 

 

(source: salty reach data V3.2) 

 

"Liberated" or "tight"? 

 

"At the end of the notice" to the original enterprise production listed within the territory of China can become the reference preparation described as consistency evaluation, "the original enterprise within the territory of China listed varieties, production by the state food and drug supervision and administration of management audit to determine after the release, can choose to reference preparation". 

 

To check the court on March 31, 2017, the public enterprise reference preparations for the record of information can be seen, there have been many branded drug companies to declare property into a reference preparations. Such as bayer to acarbose tablets information reference preparation plant origin for Beijing, acetaminophen pseudo MaMeiFen Ⅱ, ammonia hemp benzene beauty in qidong. Sanofi will have Glenn beauty urea piece of real estate in Beijing declaration for reference. Johnson & Johnson is to mix the Shanghai real estate, ibuprofen suspension declare for the reference preparation. 

 

In addition, in October 2016, after the enterprise reference preparation has declined after declaration quantity reaches the small peak. Total number of declaration for 4860, including "289 varieties" related to declare a number 289. 289 varieties in 235 has been declared, accounting for 81% of the number of varieties. 

 

Image 1 May to 16 years in March, 2017 declaration for reference preparations 

 

 

 

(source: salty reach data V3.1) 

 

Online many interpreted as: this means that the CFDA eliminated the original enterprise within the territory of China listed varieties from the consistent production process, "after the audit can be used as a reference, but not must pass since the become reference", for the property, the original medicine is a kind of "liberation". 

 

On March 18, 2017, however, administration issued by the general reference preparation oral solid preparations to choose and determine the guiding principles of three technologies such as notes, "if the original enterprise can prove that its property drugs are consistent with the original drug, real estate, drugs can also be used as reference preparation". This means that the certificate is required, since the process refer to guidelines. 

 

As for domestic generics and imported generic drugs, "at the end of the notice" is listed first in accordance with the principle of in line with the original drug quality and curative effect of reporting and review is expected to go green channel for consistency. With the "draft" lies in the difference between the green channel of the difference of process description, the product can go green channel key always lies in the drug history is recorded in the register to declare whether in accordance with the "consistent principle" to declare the relevant evidence. 

 

"At the end of the notice" to "draft" in the "domestic unique, dietary supplements, auxiliary treatment of varieties such as" referred to as "domestic special varieties. "Draft" was scheduled for such product requirements for "species list, issued by the food and drug supervision administration and evaluation institutions such as the common research methods will be in the same industry association, the committee of experts after argument, shall be separately published". It's more the set list of rules. 

 

"At the end of the notice", "by the enterprises to choose to carry out clinical trials to prove its effectiveness, safety and refer to the generic chemical medicine oral solid preparation quality and curative effect evaluation declaration data consistency requirements (try out)", the filing of the subsequent audit is passed as through consistency evaluation; enterprise did not choose to carry out clinical trials, the state food and drug supervision and administration bureau announced its lack of effectiveness data, is not recommended ". Again, it embodies the principle of consistency evaluation main body for the enterprise. Now the key point lies in what kind of products in order to be "endemic"? This definition does not reflect in the file. In the absence of defined, the enterprise is not "trap" to do the validation test. 

 

When the CFDA managing change: strict and effective 

 

"At the end of the notice" has been clear about the reference preparations, consistency, the outcome of evaluation audit institutions is the administration of state food and drug supervision and administration. 

 

On April 5, the state food and drug supervision and administration bureau issued a "about adjusting part of the decision of the administrative examination and approval procedures for examination and approval matters in the" drug and policy interpretation. Drug clinical trial (including domestic and imported), drug examination and approval decision supplementary application for examination and approval decision (including domestic and imported) and imported drugs registration approval decision before is managed by the state food and drug administration of drug administrative examination and approval decision, on May 1, after adjustment for total bureau of national food and drug supervision and administration of drug approval center in the name of the state food and drug supervision and management of administration. This means that in addition to technical evaluation work, most of the rest of the drug approval approval authority will be concentrated in the center of the state administration of food and drug supervision and administration of drug approval. 

 

Adjusted the drug clinical trial (including domestic and imported), drug examination and approval decision supplementary application for examination and approval decision (including domestic and imported), registration of imported drugs and time limit for examination and approval of will, in accordance with the "measures for the administration of drug registration regulation time limit of administrative examination and approval of the executive, is expected to the corresponding examination and approval work is expected to accelerate. 

 

From the process of adjustment and the CFDA recently released by the announcement, the CFDA still to try to speed up the review of the examination and approval, process optimization does not represent the CFDA for relaxation for examination and approval of the review, and should more as a means to an end, the CFDA willing to set out from their shorten time to speed up the efficiency of the enterprises to declare for examination and approval of the review. 

 

Summary < < < 

 

Generic quality consistency and efficacy evaluation variety classification, mean consistency evaluation of another important documents of the ground. CFDA either promote real estate since the card, to speed up the reference preparation list, the ultimate goal is consistency evaluation work as soon as possible in order to promote domestic enterprises. 

 

For the past, based on the principles of consistent declaration enterprises and products, adhere to the justice will always get feedback, and this is the when the rules are not clear still insist on product quality first enterprise should have deserved respect.