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Address: 20 Maguire Road, Suite 103, Lexington, MA 02421(America)
Tel: +1(626)986-9880
Address: Allia Future Business Centre Kings Hedges Road Cambridge CB4 2HY, UK
Tel: 0044 7790 816 954
Email: marketing@medicilon.com
Address: No.585 Chuanda Road, Pudong New Area, Shanghai (Headquarters)
Postcode: 201299
Tel: +86 (21) 5859-1500 (main line)
Fax: +86 (21) 5859-6369
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Business Inquiry
Global:
Email:marketing@medicilon.com
+1(626)986-9880(U.S.)
0044 7790 816 954 (Europe)
China:
Email: marketing@medicilon.com.cn
Tel: +86 (21) 5859-1500
On July 15, 2021, Vastpro and Medicilon signed a strategic cooperation agreement in the Medicilon Chuansha Park to reach a long-term strategic cooperation relationship.
At the signing ceremony, Dr. Chunlin Chen, Founder & CEO of Medicilon, first extended a warm welcome to the visit of Vastpro and his entourage, and expressed his enthusiasm and confidence in the upcoming strategic cooperation between the two parties.
IND, Investigational New Drug, generally refers to a new drug that has not been approved for marketing and is undergoing clinical trials at various stages. In actual applications, IND or CTA (clinical trial application) has become synonymous with pre-marketing human clinical trials.
The IND application may be one or a sequential group of studies, with the purpose of obtaining evidence of product safety and effectiveness. Generally speaking, INDs can be divided into commercial INDs and non-commercial INDs.
Pharmaceutical Research of Innovative Drug IND Application
In 2013, the FDA again issued a guideline “Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND”.
The guideline is designed to help clinical applicants determine whether relevant studies must be Research, such as 21 CFR 312; and specified when an IND application is required and under what circumstances an IND application is not required, and a certain scope of application has been determined.
The United States Exempts the IND's BA/BE Safety Report Requirements
Not all BA/BEs meet the requirements of IND exemption (that is, there is no need to submit an IND application and perform clinical trials in accordance with IND requirements). For example, BA/BE involving cytotoxic drugs does not meet the requirements of IND exemption.
The guidelines followed by the US IND and BA/BE safety reports are 21 CFR 312.32, 312.64(b) and 320.31(d)(3). The requirements and time limits of the two security reports are not consistent. The former focuses on reports of suspicious and unexpected serious adverse events (SUSAR), while the latter focuses on reports of serious adverse events (SAE).