ich guidelines list, ich guidelines full form

 

ich guidelines list, ich guidelines full form

What is ICH guidelines?

ICH stands for International
Conference of Harmonization to provide uniform standards for technical requirements, for pharmaceutical and for human use. It is developed by regulatory and firm industry authorities. The purpose of ICH guidelines is to ensure safety effectiveness and high quality medicines are developed and registered efficiently.

What is the Origin of ICH guidelines?
ICH was pioneered by Europe in 1980 & there are discussion between Europe, Japan and US on possibilities for harmonization. The name ICH was given at the meeting in April 1990. Topic for harmonization would be divided into safety, quality and efficacy.

What are types of ICH guidelines?
The ICH guidelines categorized into four types.
1)quality guidelines
2)safety guidelines
3)efficacy guidelines
4)multi-disciplinary guidelines.
Number one is quality guidelines. The quality
guidelines are divided into following types. Q1A to Q1F for stability,
Q2 for analytical validation,
Q3A to Q3D for impurities,
Q4 to Q4B for pharmacopias,
Q5A to Q5E for quality of biotechnical products,
Q6A to Q6B for specific sense,
Q7 for good manufacturing practices GMP,
Q8 for pharmaceutical development,
Q9 for quality management,
Q10 for pharmaceutical quality system,
Q11 for development and manufacture of drug substance,
Q12 for life cycle management,
Q13 for continuous of drug substance and drug products
Q14 for analytical procedure
development.

Next is safety guidelines.
Safety guidelines divided into following types.
S1A to S1C for carcinogenicity studies,
S2 for genotoxicity studies,
S3A to S3B for toxicokinetics & pharmacokinetics,
S4 for toxicity testing,
S5 for reproductive toxicology,
S6 for biotechnological products,
S7A to S7B for pharmacology studies
S8 for immunotoxicity study,
S9 for non-clinical evaluation for
anti-cancer pharmaceuticals,
S10 for photosafety evaluation
S11 is for non-clinical
pediatric safety.

Next is efficacy guidelines.
Efficacy guidelines divided into following types.
E1 for clinical safety for drug in long-term
treatment,
E2A to E2F for pharmacovigilance,
E3 for clinical study reports,
E4 for doses response studies,
E5 for ethnic factors,
E6 for good clinical practice,
E7 for clinical trial in geriatric population,
E8 for general consideration for clinical trial,
E9 for statistical principle for clinical trials, E10 for choice of control group in clinical trial,
E11 to E11A for clinical trial in pediatric population,
E2L for clinical evaluation by therapeutic category,
E14 for clinical evaluation of QT,
E15 for definition of pharmacogenetics,
E17 for multi-regional clinical trials
E18 is for genomic sampling.

multi-disciplinary guidelines.
It is divided into following types.
M1 for mid-DRA terminology,
M2 for electronic standards,
M3 for non-clinical safety studies,
M4 for common technical documents,
M5 for data elements and standards for drug dictionary,
M6 for gene therapy,
M7 for mutagenic impurities,
M8 for electronic common technical documents,
M9 for biopharmaceuticals, classification system based BioA virus,
M10 for bioanalytical method validation.