Adoption of the ICH Q4 Pharmacopoeial Test Method Workshop was held in Beijing

2018-11-17

In order to push forward the transformation and implementation of ICH Q4B-related technical guidelines in China, promote the coordination of domestic drug regulatory concepts, methods and standards with international levels, strengthen international  technical exchange of pharmacopoeia standards, and continuously improve the Chinese Pharmacopoeia related test methods, the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Pharmacopoeial Testing Method (Q4) Workshop was co-jointly held by Chinese Pharmacopoeia Commission (ChP)and the Chinese Pharmacopoeia Commission and China Center for Food and Drug International Exchange (CPCCCFDIE)in Beijing during October 30-31, 2018. More than 20 experts from Chinese Pharmacopoeia Commission, United States Pharmacopoeia Commission and ICH Expert Working Group (EWG) have conducted extensive technical exchanges and discussions on the organizations, workflow, harmonized management procedures for pharmacopoeial standards for ICH Q4 and PDG, standard harmonized case analysis, assessment of difference between ICH Q4B-related guidelines and Chinese Pharmacopoeia, implementation strategies, test methods suitability study and future development frontiers of relevant test methods.
A closed-door meeting was held among the relevant experts from Chinese Pharmacopoeia Commission, experts from ICH Q4 Expert Working Group (EWG) and representatives from relevant pharmaceutical enterprises at home and abroad, discussing how to establish close contact with the ICH Q4 Expert Working Group, participate in the coordination of the PDG, strengthen communication with the domestic and foreign industry, and improve the formation mechanism of the Chinese Pharmacopoeia standards during the technical exchange meeting. Meanwhile, the relevant experts from Chinese Pharmacopoeia Commission have interpreted the implementation of current Chinese Pharmacopoeia.
This Workshop has played an active role in overall understanding ICH Q4 standards coordination and working procedures by drug regulatory authorities and manufacturers in China, carrying out assessment of differences between ICH Q4B and Chinese Pharmacopoeia related test methods in a deep-going way, enhancing the understanding of ICH Q4B related method formulation, and further promoting the coordination and implementation of Chinese Pharmacopoeia and ICH Q4B methods.
This Workshop was strongly supported by the China Association of Enterprise with Foreign Investment R&D-Based Pharmaceutical Association Committee (RDPAC).

1. ICH and Q4B Pharmacopeias Harmonization.pdf

2. PDG and Global Pharmacopeial Collaboration.pdf

3. Implementation and Opportunities.pdf

4. Above and Beyond ICH Q4B:Global Pharmacopoeia Harmonization-Industry Perspective.pdf

5. Evaluation of Differences Between Chinese Pharmacopoeia and ICH Q4B Standard and Consideration of Harmonization Strategies.pdf

6. Introduction on the Sterility Test and Microbial Limits Test in ChP.pdf

7. Issues with the Sterility Test Application.pdf

8. Evaluation on Testing Results of Sterility Testing.pdf

9. Microbial Limits Test Applicability Study and Consideration Points on the Pathogenic Bacteria Testing, Testing Methods Validation Study.pdf

10. Considerations on the Microbial Enumeration Test.pdf

11. Microbial Limit Test of Chinese Pharmacopeia.pdf

12. Harmonisation of standards for Bacterial Endotoxins Test.pdf

13. Issues in the Bacterial Endotoxin Test.pdf

14. In Vitro Dissolution Test - An Overview Between ICH and Ch.P. Requirement.pdf

15. Dissolution Methods Development for Immediate Release Oral Solid Formulation.pdf

16. Key Considerations for Developing Test Method of Dissolution.pdf

17. Introduction of Test for Particulate Contamination.pdf