| General Chapter No. |
Guideline |
| 9001 |
Guidelines for the Stability Testing of Drug Substances and Preparations |
| 9011 |
Guidelines for In Vivo Bioavailability and Bioequivalence Studies on Drug Preparations |
| 9012 |
Guidelines for Validation of Quantitative Analytical Methods for Biological Samples |
| 9013 |
Guidelines for Sustained, Controlled and Delayed Release Preparations |
| 9014 |
Guidelines for Microparticle Preparations |
| 9015 |
Guidelines for Studies and Quality Control of Drug Polymorphism |
| 9099 |
Guidelines for Analytical Method Verification |
| 9100 |
Guidelines for Analytical Method Transfer |
| 9101 |
Guidelines for Analytical Method Validation |
| 9102 |
Guidelines for the Analysis of Impurities in Drugs |
| 9103 |
Guidelines for Hygroscopicity Trials for Pharmaceuticals |
| 9104 |
Guideline for Near-infrared (NIR) Spectrophotometry |
| 9105 |
Guidelines for Bioactive Assays of Traditional Chinese Medicines |
| 9106 |
Guidelines for Pharmaceutical Evaluation Based on Microarrays |
| 9107 |
Guidelines for DNA Barcoding for the Molecular Identification of Traditional Chinese Medicine Ingredients |
| 9108 |
Technical Guidelines for DNA Sequencing |
| 9109 |
Guidelines for the Establishment of Standard Nucleic Acid Sequences |
| 9201 |
Guidelines for the Validation of Alternative Microbial Detection Methods for Pharmaceuticals |
| 9202 |
Guidelines for Microbial Limit Tests for Non-sterile Products |
| 9203 |
Guidelines for Quality Management of Microbiology Laboratory for Pharmaceutical Products |
| 9204 |
Guidelines for Microbial Identification |
| 9205 |
Guidelines for Microbiological Monitoring and Control of Clean Laboratories for Pharmaceutical Products |
| 9206 |
Guidelines for Validation of Isolator Systems for Use and Application in Sterility Testing |
| 9207 |
Guidelines for Biological Indicators for Sterilization |
| 9208 |
Guidelines for Resistance Performance Tests for Biological Indicators |
| 9251 |
Guidelines for the Application of Bacterial Endotoxin Tests |
| 9301 |
Guidelines for the Application of Safety Tests for Injections |
| 9302 |
Guidelines for Establishing Limits for Harmful Residues of Traditional Chinese Medicines |
| 9303 |
Guidelines for Determination of Pigments |
| 9304 |
Guidelines for Determination of Aluminium (Al), Chromium (Cr), Iron (Fe) and Barium (Ba) in Traditional Chinese Medicines |
| 9305 |
Guidelines for Determination of Mycotoxins in Traditional Chinese Medicines |
| 9306 |
Guidelines for Genotoxic Impurity Control |
| 9401 |
Guidelines for Validation of Bioactivity/Potency Testing Methods for Biological Products |
| 9402 |
Guidelines for Stability Testing of Biological Products |
| 9501 |
Guidelines for Quality Control of Positron Emission Tomographic Radiopharmaceutical Preparations |
| 9502 |
Guidelines for Quality Control of Technetium [99mTc] Radiopharmaceuticals |
| 9601 |
Guidelines for Research and Evaluation on Functionality-related Characteristics of Pharmaceutical Excipients |
| 9602 |
Guidelines for Pharmaceutical Excipients of Animal Origin |
| 9603 |
Guidelines for Quality Control of Premixed and Co-processed Pharmaceutical Excipients |
| 9621 |
Guidelines for General Requirements for Drug Packaging Materials and Containers |
| 9622 |
Guidelines for Pharmaceutical Glass Materials and Containers |
| 9901 |
National Guidelines for Preparation of Pharmaceutical Standard Substances |
Market | Chemical | Food | Cosmetic | BaiPharm | Agrochemical
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