News & Events - Hillgene Biopharma Co., Ltd.

12 2021.07

Live丨Writing a New Chapter for Cellular and Gene Therapies, Paving the Road to an Innovatively Developed and Industrialized Future

Cell and gene therapy technology is undoubtedly one of the most popular biotechnology fields at present, and is also regarded as the next generation of innovative therapies for disease treatment. In t...

12 2021.07

NMPA issued the “Measures for the Administration of Drug Inspection (Interim)”, and abolished the original drug administrative measures for GMP and GSP certification!

Chapter I General ProvisionsArticle 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Vaccine Administration Law of the People&#...

10 2021.02

Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Clinical Trial of Cell-based Immunotherapy Products (Interim)” (No. 14, 2021)

In 2017, the former State Food and Drug Administration issued the "Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial)", which generally elaborated on the techn...

31 2020.12

[IIT] Announcement on Public Comment Soliciting on the “Administrative Measures for Investigator Initiated Clinical Trials by Medical and Health Institutions (Draft for Comments)”

Measures for the Administration of Clinical Research Initiated by Medical and Health Institutions(Draft for Comments)Chapter I General ProvisionsArticle 1 (Purpose) In order to standardize the managem...

14 2020.09

Notification of Public Comment Soliciting on “Technical Guideline for the Pharmaceutical Study and Evaluation of Gene Therapy Products (Draft for Comments)”

Technical Guidelines for Pharmaceutical Research and Evaluation of Gene Therapy Products(Draft for Comments)ForewordIn recent years, with the continuous advancement of gene delivery systems and editin...

06 2020.07

Notification of Public Comment Soliciting on “Technical Guideline for the Pharmaceutical Study and Evaluation of Cell-based Immunotherapy Products (Draft for Comments)”

In 2017, the former State Food and Drug Administration issued the "Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial)", which generally elaborated on the techn...

30 2020.03

Newly Revised “Provisions for Supervision and Administration of Drug Manufacturing”

Chapter I General ProvisionsArticle 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administra...

30 2020.03

Newly Revised “Provisions for Drug Registration”

Chapter I General ProvisionsArticle 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the "Drug Admi...

02 2020.03

The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Reference Template for Quality Agreement on Drug Consignment Production (Draft for Comments)”

1. Definition"Audit": refers to the inspection and evaluation of the production quality management system of the trustee by the holder."Batch": a certain amount of raw materials, p...

02 2020.03

The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Guidelines for Quality Agreement on Drug Consignment Production (Draft for Comments)”

1. Purpose and ScopeThis guideline is formulated to regulate drug entrusted production, ensure drug quality and safety, guide and supervise drug marketing authorization holders (hereinafter referred t...

02 2020.03

The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Inspection Procedures of Drug Product MAHs (Draft for Comments)”

1. PurposeThis procedure is formulated to implement the Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China, fully im...

02 2020.03

The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Key Points for Inspection of Drug Product MAHs (Draft for Comments)”

The key points for drug marketing authorization holder inspection are mainly used to provide guidance to drug regulatory authorities at all levels when conducting supervision and inspection on drug ma...