Table 1.
Regulations and guidelines related to vaccine stability.
| Issue Date | Name of Regulation | Issuing Agency /Country |
Reference |
|---|---|---|---|
| 1989 | Stability of vaccines (WHO/EPI/GEN/89.08) | WHO | [4] |
| 1995 | Stability testing of biotechnological/biological products—Scientific guideline (ICH Q5C) | ICH | [6] |
| 1998 | Thermostability of vaccines (WHO/GPV/98.07) | WHO | [5] |
| 2003 | Evaluation for Stability Data Q1E | ICH | [16] |
| 2003 | Stability Testing of New Drug Substances and Products Q1A(R2) | ICH | [17] |
| 2011 | Guidelines on Stability Evaluation of Vaccines | WHO | [8] |
| 2012 | Controlled Temperature Chain (CTC) Guidelines | WHO | [18] |
| 2013 | Extended Controlled Temperature Conditions (ECTC) Guidelines | WHO | [19] |
| 2015 | Technical Guidelines for Stability Studies of Biological Products | CDE/China | [9] |
| 2018 | Liposomal Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetic and Bioavailability; and Labeling Documentation | FDA/USA | [14] |
| 2020 | 2020 Chinese Pharmacopoeia Section 4 Regulation 9402 Guidelines for stability testing of biological products |
Chinese Pharmacopoeia Commission /China |
[10] |
| 2021 | Evaluation of the quality, safety, and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations | WHO | [13] |
| 2022 | Technical Guidelines for the Pharmacological Study and Evaluation of In Vivo Gene Therapy Products (draft edition) | CDE/China | [15] |