CRO
Introduction:

Investigational New Drug (IND) registration refers to the process by which the drug registration applicants submit an application as per statutory procedures and related requirements, and drug regulatory authorities decided whether or not to approve the application after reviewing the safety, efficacy and quality controllability according to laws and regulations and existing scientific recognition.

Based on Pracgen's extensive experience in gene and cell therapy drugs development and appiication, Pracgen provides IND registration services for cell and gene therapy products.

Procedure:

       Registration consultation and guidance for R & D whole process

       Project management

       Evaluation and preparation of ICH-CTD application dossiers

       Clinical trial protocol and dossiers preparation

       CDE/FDA communication meeting


Advantages:
  • Advantages

    Professional registration service team 

    Rich  experience in macromolecule antibody drugs and gene/cell therapy products

    Powerful ability in clinical resources coordination

    Personalized and flexible means of cooperation

  • Successful Cases

    Type 1 Therapeutical Biologics (Antibody) 1 cases

    Type 2 Therapeutical Biologics (Antibody Biosimilar) 5 cases

    Type 1 Therapeutical Biologics (Autologous CAR T cell product) 2 cases

More Info:

l  Cell and gene therapy regulations

(1)Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial)

https://www.nmpa.gov.cn/ylqx/ylqxggtg/ylqxzhdyz/20171222145101557.html

(2)Interpretation of Issues Related to the Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial)

https://www.nmpa.gov.cn/xxgk/zhcjd/zhcjdyp/20171222145901282.html

(3)    Thoughts on the Application of Non-registered Clinical Trials for Drug Registration Review

http://www.cde.org.cn/dzkw.do?method=largePage&id=314360

(4)   Key points to consider when applying for clinical trial Pharmaceutical studies and application information for cell therapy products http://www.cde.org.cn/news.do?method=largeInfo&id=ffacd65c6758298d 

(5) Some of the current considerations on Non-Clinical Research and Evaluation of CAR-T Products

http://www.cde.org.cn/dzkw.do?method=largePage&id=314391

(6)  Key Consideration for Quality Control Testing Studies and Non-Clinical Studies of CAR-T Cell Therapy Products

http://www.ccpie.org/cn/yjxx/yphzp/webinfo/2018/06/1523832302271229.htm

(7)    Consideration for Clinical Trial Design of Chimeric Antigen Receptor T Lymphocytes for the Treatment of Lymphohematopoietic Malignancies

http://www.cde.org.cn/dzkw.do?method=largePage&id=314760

(8)    Self-discipline Specifications for Quality Management of Immune Cell Preparation  (China Medicinal Biotechnology Association)

http://www.cmba.org.cn/common/index.aspx-nodeid=283&page=ContentPage&contentid=4458.htm

(9) Quality Management Specification for Preparation of Chimeric Antigen Receptor Modified T Cells (CAR-T cells) Formulation .( China Medicinal Biotechnology Association)

http://www.cmba.org.cn/common/index.aspx-nodeid=283&page=ContentPage&contentid=4459.htm

(10)Questions and Answers on Pharmaceutical Studies for Clinical Trials Application of Cell Therapy Product  (Issue I)

http://www.cde.org.cn/news.do?method=largeInfo&id=64b24f46cbea8dae

(11)GMP Appendix - Cell Therapy Products (Exposure Draft)

http://www.cfdi.org.cn/resource/news/11931.html

(12)Technical Guidelines for Clinical Trials of Immune Cell Therapy Products (Trial)

http://www.cde.org.cn/news.do?method=largeInfo&id=9da2b313cd79f360

l  FDA cell and gene therapy regulations

Cellular & Gene Therapy Guidances

https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/cellular-gene-therapy-guidances

 

l  EMA cell and gene therapy regulations

Multidisciplinary: gene therapy

https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/multidisciplinary/multidisciplinary-gene-therapy

 

Guidelines relevant for advanced therapy medicinal products

https://www.ema.europa.eu/en/human-regulatory/research-development/advanced-therapies/guidelines-relevant-advanced-therapy-medicinal-products

 

Support for advanced-therapy developers

https://www.ema.europa.eu/en/human-regulatory/research-development/advanced-therapies/support-advanced-therapy-developers

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