Group Standard: "Specification for the Supply and Management of Drugs Used in Clinical Trials of Biological Products" Released (Part 5) - Appendix and References
Date:
2025-08-08
Source:
Huaren Pharmaceutical Clinvantage participated in the formulation and drafting of the "Specifications for the Supply and Management of Biological Products Used in Clinical Trials," jointly released by the China Vaccine Industry Association and the China Standardization Association. This is a normative standard document in China for the supply and management of biological products used in clinical trials.
References
[1]National Pharmacopoeia Committee, Pharmacopoeia of the People's Republic of China: 2020 Edition, Part III
[2]National Medical Products Administration, "Pharmaceutical Administration Law of the People's Republic of China" (2019) No. 31
[3]National Medical Products Administration, National Health Commission, "Good Clinical Practice for Drugs" (2020) No. 57
[4]State Administration for Market Regulation, "Regulations on Drug Registration Management" (2020) No. 27
[5]National Medical Products Administration, "Good Manufacturing Practice for Drugs (2010 Revision)" Appendix for Investigational Medicinal Products (2022) No. 43
[6]State Food and Drug Administration, "Good Management Practice for Drug Operation" (2016) No. 28
[7]National Medical Products Administration Center for Drug Evaluation, "Key Points and Determination Principles for Drug Registration Review (Drug Clinical Trials) (Trial)" (2021) No. 30
[8]National Medical Products Administration, National Health Commission, "Regulations on the Management of Drug Clinical Trial Institutions" (2019) No. 101
[9]National Medical Products Administration, "Regulations on the Production and Circulation Management of Vaccines" 2022 No. 55
[10]National Medical Products Administration Center for Drug Evaluation, "Guiding Principles for Random Allocation of Drug Clinical Trials (Trial)" (2022) No. 5
[11]National Medical Products Administration Center for Drug Evaluation, "Guiding Principles for Blinding in Drug Clinical Trials (Trial)" (2022) No. 49
[12]National Medical Products Administration, "Announcement on Matters Concerning the One-time Import of Research Control Drugs Needed in the Research Process" (2016) No. 120
[13]National Medical Products Administration, "Announcement on Matters Concerning the One-time Import of Reference Drugs for Clinical Trial Biological Products" (2018) No. 94
[14]National Medical Products Administration Center for Drug Evaluation, "Guiding Principles for the Management of Drug Clinical Trials During the COVID-19 Pandemic (Trial)" (2020) No. 13
[15]"Maintaining Blindness in the Implementation of Drug Clinical Trials - Guangdong Consensus (2021 Edition)" (Guangdong Pharmaceutical Society, October 13, 2021)
[16]EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 13 Investigational Medicinal Products
[17]EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release
[18]Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections
[19]REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
[20]FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs
[21]FDA INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information
[22]FDA guideline on the preparation of investigational new drug products (human and animal) March 1991 (reprinted November 1992)
[23]FDA Code of Federal Regulations (CFR) PART 210 current good manufacturing practice in manufacturing, processing, packing, or holding of drugs: general
[24]FDA Code of Federal Regulations (CFR) PART 211 current good manufacturing practice for finished pharmaceuticals
[25]WHO Good manufacturing practices for investigational products
[26]ICH harmonized guideline good clinical practice (GCP) E6(R3)
Related News
The "Specifications for the Supply and Management of Drugs Used in Clinical Trials of Biological Products," jointly issued by the China Vaccine Industry Association and the China Standardization Association, was developed and drafted with the participation of Huaren Pharmaceutical Clinvantage. It is a normative standard document in China for the supply and management of drugs used in clinical trials of biological products.
The "Specifications for the Supply and Management of Drugs Used in Clinical Trials of Biological Products," jointly issued by the China Vaccine Industry Association and the China Standardization Association, was developed and drafted with the participation of Huaren Pharmaceutical Clinvantage. It is a normative standard document in China for the supply and management of drugs used in clinical trials of biological products.
The "Specifications for the Supply and Management of Drugs Used in Clinical Trials of Biological Products," jointly issued by the China Vaccine Industry Association and the China Standardization Association, was developed and drafted with the participation of Huaren Pharmaceutical Clinvantage. It is a normative standard document in China for the supply and management of drugs used in clinical trials of biological products.
The "Specifications for the Supply and Management of Drugs Used in Clinical Trials of Biological Products," jointly issued by the China Vaccine Industry Association and the China Standardization Association, was developed and drafted with the participation of Huaren Pharmaceutical Clinvantage. It is a normative standard document in China for the supply and management of drugs used in clinical trials of biological products.
The "Specifications for the Supply and Management of Drugs Used in Clinical Trials of Biological Products," jointly issued by the China Vaccine Industry Association and the China Standardization Association, was developed and drafted with the participation of Huaren Pharmaceutical Clinvantage. It is a normative standard document in China for the supply and management of drugs used in clinical trials of biological products.