A large number of Indian generic drugs, or will flood into China
Medical Network July 20th The latest national policy has created more convenient conditions for Indian generics to enter China.
On July 10, the State Drug Administration issued the “Technical Guidelines for Accepting Clinical Clinical Trial Data of Drugs”, recognizing the clinical trial data obtained from overseas and domestically synchronized research and development of innovative drugs, and having fully evaluable bioequivalence. Sex data for the development of generic drug development data abroad.
The criteria for the evaluation of overseas clinical trial data approved by the State Food and Drug Administration include the authenticity, completeness, accuracy, traceability, effectiveness and safety of overseas clinical trial data, and the study of ethnic differences.
For critical illness, rare diseases, pediatrics and lack of effective treatment Drug registration Application, after assessing that the clinical trial data of the country is part of the 'partially accepted' situation, the conditional acceptance of clinical trial data may be used. drug Further effectiveness and safety data are collected for evaluation after listing.
This is actually a supplement to another policy two months ago. On May 23, the State Food and Drug Administration and the State Health and Health Commission jointly issued the "Announcement on Optimizing the Approval of Drug Registration Review and Approval", which mentioned that it has been The prevention and treatment of listed drugs is seriously life-threatening and there are no effective treatments for diseases and rare disease drugs. If the applicant for imported drug registration believes that there is no ethnic difference, it can submit the clinical trial data obtained overseas to directly apply for drug listing registration.
For the above-mentioned imported drug clinical trial applications that have been accepted and proposed for the reduction and exemption of clinical trials before the issuance of this announcement, in line with the requirements of the Drug Registration Management Measures and related documents, the import may be directly approved.
The introduction of these two major policies, the industry believes that this is a sign of the liberalization of the import registration category 5.2, especially the Indian generic drugs that have been approved for many years and are expected to be approved.
▍This means that the following categories of drugs may benefit from this policy:
Innovative drugs, Phase III clinical trials include studies of East Asian ethnic groups, especially Chinese subgroups.
Imported generic drugs / domestic collinear production of generic drugs, the original research drugs have done the above-mentioned study of East Asian ethnic groups, especially the Chinese subgroup.
Clinically necessary drugs, such as critical illness, rare diseases, pediatrics, and drugs that lack effective treatments can be appropriately relaxed standard However, after the listing, it is still necessary to collect further validity and safety data for re-evaluation after listing.
This means that products imported from China or Japan that are imported by generic manufacturers are likely to benefit from the policy. The most important effect of introducing such imported generic drugs is the expired original drug, and the import of generic drugs will further promote the expiration. The price reduction of the original drug.
▍Imported generics: India’s most declared
The company has compiled a list of products that have declared 5.2 categories of imports, ie imported generic drugs, since 2016. The countries and regions with the most declared products are India, followed by Switzerland, Taiwan and Greece again.
The most declared products enterprise For Dr. Reddy India, the products include deferasis dispersible tablets, abiraterone acetate tablets, fulvestrant injection, sildenafil citrate orally, rivaroxaban tablets and carbamide The film is followed by Novartis/Sanders, and the declared products include escitalopram oxalate tablets, voriconazole tablets, mometasone furoate nasal spray, salmeterol and dexamethasone powder inhalation and levetiracetam tablets.
Many domestic manufacturers have participated in the introduction of 5.2 imported drugs, such as Jiangsu Xiansheng and Celon Pharma SA, China Resources Jiuxin and Farmerson, Zico and BioQ Pharma Limited, HOLOPACK Verpackungstechnik GmbH, Guangzhou Hanguang and Cooperation of Pharmanel Commercial Pharmaceutical SA.
Table List of products for category 5.2 declarations from 2016 to the present
Declaration type
Drug Name
Company Name
country / region
Reporting year
Apply for clinical
Prefilled continuous administration system of ropivacaine hydrochloride injection
Lidocaine hydrochloride powder needle-free percutaneous injection drug delivery system
Pule Pharmaceutical
Hong Kong
2016
Apply for clinical
Deferasis dispersible tablets
Indian Reddy Dr.
India
2018
Apply for clinical
Nifedipine controlled release tablets
Shengda Chemical
Taiwan
2018
Apply for clinical
Sodium polymyxin E mesylate for injection
Taiwan Toyo
Taiwan
2017
Apply for clinical
Glutamic acid glucamine injection
General Electric
United States
2017
Apply for clinical
Fulvestrant injection
Indian Reddy Dr.
India
2017
Apply for clinical
Sildenafil citrate orally disintegrating tablets
Indian Reddy Dr.
India
2017
Apply for clinical
Rivaroxaban tablets
Indian Reddy Dr.
India
2017
Apply for clinical
Acetate acetate tablets
Indian Reddy Dr.
India
2018
Apply for clinical
Sevelamate tablets
Indian Reddy Dr.
India
2018
Apply for production
Drospirone ethinyl estradiol tablets
Exeltis Magyarország Kft./Laboratorios León Farma, S. A.
Portugal
2018
Apply for production
Cefazolin sodium/sodium chloride injection for injection
Otsuka Pharmaceutical Factory, Inc.
Japan
2016
Apply for production
Levetiracetam tablets
Alabindo
India
2018
Apply for production
Ambroxol hydrochloride solution for inhalation
Korean medicine
Korea
2017
Apply for production
Docetaxel injection
Pfizer / HOSPIRA
America England
2017
Apply for production
Acarbose tablets
Meishi Chemical
Taiwan
2017
Apply for production
Olanzapine orally disintegrating tablets
Indian sun
India
2017
Apply for production
Bicalutamide tablets
Indian sun
India
2018
Apply for production
Clopidogrel hydrogen sulfate tablets
Yosemite Pharmaceutical
Taiwan
2017
Source: Xianda Medicine Sea Swim Tour
Summary
After China's entry into the ICH, it is expected that the approval of imported generic drugs will be accelerated. However, the mutual recognition of overseas clinical data is still being explored. The criteria for the overseas clinical data need to be supplemented are still not established, and the possibility of approval in the short term is large. Relatively low.
In the long run, if imported generic drugs meet the domestic consistency evaluation standards and the price is low, it will inevitably cause impact on domestic generic drug manufacturers.
The competition of generic enterprises will enter the cost competition, and domestic enterprises must start from product projects, raw materials and Excipient Supply, production efficiency, sales coverage and other aspects of comprehensive consideration of countermeasures.
