On May 24, China Center for Drug Evaluation (CDE) released the draft Notice of Generic Drug Study Without Reference Listed Drugs (RLDs) (hereafter referred to as the Notice). The draft states the precondition for developing copycats of drugs which are not listed in China’s RLD Catalog—the drugs have to be widely used, with no alternatives, and with benefits trumping risks.
In the Notice, CDE raises the following requirements for applicants:
1. Clinical Value Orientation
Before developing a generic version of an RLD-free-drug, the applicant should sufficiently evaluate the drug’s value to make sure it is a mainstream, widely-used, and irreplaceable therapy whose clinical benefit outweighs risks, proved by well-designed clinical trials with enough clinical data.
2. Quality Improvement with Stringent Standards
The applicant should conduct the study of generic drugs based on effective technical requirements, and comprehensively assess the quality of the marketed drug of the same type (with the same generic name). The to-be-developed generic version should be equivalent to or better than the marketed drug which already has sufficient research results, excellent marketing authorization basis, and a fairly big share in the targeted market of the specific therapeutic area.
3. CMC Study, Clinical Value Assessment, and Clinical Study
The applicants should conduct the chemistry, manufacturing, and control (CMC) study, expected clinical value assessment, and clinical study. Firstly, the applicant should submit the communication application (category III) to CDE with the research documents. If the documents comply with CDE’s requirements, the applicant can hand in the clinical trial application. Only after CDE evaluates the application, which will be completed within 60 workdays after receiving the application, and releases the clinical trial notice can the applicant conduct clinical trials.
4. ANDA
After completing clinical study, the applicant should submit the abbreviated new drug application (ANDA) to CDE. This process for RLD-free-drugs is the same for generic drugs with RLDs.
5. Notes:
Clinical trial exemption:
Glucose Injection, Sodium Chloride Injection, Vitamin B2, Vitamin B6, Calcium Carbonate and Vitamin D3 Chewable Tablets, and other basic infusions and nutritional drugs are exempted from clinical trials.
Dossier Requirements for CMC Study on Drugs with No RLDs:
The application dossier should include the information on multiple marketed products from different brands and with different marketing authorization holders (MAHs). The products are of the same drug with the same generic name.
The information should include but is not limited to:
1. Basic information:
- generic name (Chinese);
- English name;
- dosage form;
- brand name;
- strength;
- MAH’s name and address;
- manufacturer’s name and address;
- Countries and dates of the product being marketed.
2. Legitimate source evidence
- purchase invoices;
- proof for receiving the drug without financial costs;
3. Medication package inserts (original copy and its Chinese translation)
4. Photo of the drug, etc.
Regional information in the dossier’s module 2 should include a summary of the abovementioned information. In module 3, regional information should contain the detailed and complete documents of the information specified above.
Ask BaiPharm if you’d like to know more about generic drug registration (ANDA) in China.
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