Industry News - Hillgene Biopharma Co., Ltd.

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...

28 2019.11

NMPA (formerly CFDA) Solicits Public Comments on “Good Manufacturing Practice (GMP) – Appendix for Cellular Therapy Drugs” (Draft for Comments)

Chapter 1 ScopeArticle 1 [Scope] The cell therapy products described in this appendix refer to living cell products of human origin, including products produced by cell lines, as well as immune cells,...

27 2019.08

Full text of the new “Drug Administration Law of the People's Republic of China”

City license. The transferee shall have the quality management, risk prevention and control, and liability compensation capabilities to ensure the safety, effectiveness, and quality controllability of...

10 2019.06

Proclamation of the “General Instructions on Human Gene Therapy Products (Draft)”

General Introduction to Gene Therapy Products for Human Use (Draft for Public Notice)OverviewGene therapy products are usually composed of vectors or delivery systems containing engineered gene constr...

29 2019.03

The General Office of the National Health Commission issued the Letter of Opinion on “Administrative Measures for the Clinical Research and Translational Use of Somatic Cell Therapy (Interim)

Chapter 1 General ProvisionsArticle 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China and the Regulations on the Administration of Me...

07 2018.09

Announcement of “Regulations on Manufacturing Quality Management for Chimeric Antigen Receptor T Cell (CAR-T cell)-based Drug Products”

In recent years, immunotherapy has experienced a series of rapid developments. New immunotherapy technologies represented by specific adoptive immune cell therapy and immune checkpoint antibody therap...