Regulatory Affairs: CTD & ICH

Regulatory affairs (RA): CTD and ICH referenceامور رگولاتوری (RA): مرجع CTD و ICH

The Common Technical Document (ICH M4) module structure, the ICH guidelines most used in quality work, and the ICH Q1A(R2) stability storage conditions.

Common Technical Document (CTD) structureساختار سند فنی مشترک (CTD)

Module 1: Regional administrative informationماژول 1: اطلاعات اداری منطقه‌ای

Application forms, labelling and regional documents; not part of the common CTD

Module 2: Summariesماژول 2: خلاصه‌ها

2.3 Quality overall summary
2.4 Nonclinical overview
2.5 Clinical overview
2.6 Nonclinical summaries
2.7 Clinical summary

Module 3: Quality, drug substance (3.2.S)ماژول 3: کیفیت، ماده مؤثره (3.2.S)

S.1 General information
S.2 Manufacture
S.3 Characterisation
S.4 Control of drug substance
S.5 Reference standards
S.6 Container closure system
S.7 Stability

Module 3: Quality, drug product (3.2.P)ماژول 3: کیفیت، فرآورده دارویی (3.2.P)

P.1 Description and composition
P.2 Pharmaceutical development
P.3 Manufacture
P.4 Control of excipients
P.5 Control of drug product
P.6 Reference standards
P.7 Container closure system
P.8 Stability

Module 4: Nonclinical study reportsماژول 4: گزارش‌های مطالعات غیربالینی

Pharmacology, pharmacokinetics and toxicology reports

Module 5: Clinical study reportsماژول 5: گزارش‌های مطالعات بالینی

Biopharmaceutic, pharmacokinetic, efficacy and safety study reports

ICH guidelinesراهنماهای ICH

Code	Subject
Q1A(R2)	Stability testing of new drug substances and products
Q1B	Photostability testing
Q2(R2)	Validation of analytical procedures
Q3A(R2)	Impurities in new drug substances
Q3B(R2)	Impurities in new drug products
Q3C	Residual solvents
Q3D	Elemental impurities
Q6A	Specifications for chemical substances and products
Q7	Good manufacturing practice for active ingredients
Q8(R2)	Pharmaceutical development
Q9(R1)	Quality risk management
Q10	Pharmaceutical quality system
Q11	Development and manufacture of drug substances
Q12	Product lifecycle management
Q13	Continuous manufacturing
Q14	Analytical procedure development
M4	The Common Technical Document
M7	Mutagenic impurities
M9	Biopharmaceutics Classification System-based biowaivers
M10	Bioanalytical method validation

Stability study conditions (ICH Q1A, general case)شرایط مطالعه پایداری (ICH Q1A، حالت کلی)

Study	Storage condition	Minimum data at submission
Long-term	25 °C ± 2 °C / 60% RH ± 5% \| 30 °C ± 2 °C / 65% RH ± 5%	12 months
Intermediate	30 °C ± 2 °C / 65% RH ± 5%	6 months
Accelerated	40 °C ± 2 °C / 75% RH ± 5%	6 months

Common Technical Document (CTD) structureساختار سند فنی مشترک (CTD)

Module 1: Regional administrative informationماژول 1: اطلاعات اداری منطقه‌ای

Application forms, labelling and regional documents; not part of the common CTD

Module 2: Summariesماژول 2: خلاصه‌ها

2.3 Quality overall summary
2.4 Nonclinical overview
2.5 Clinical overview
2.6 Nonclinical summaries
2.7 Clinical summary

Module 3: Quality, drug substance (3.2.S)ماژول 3: کیفیت، ماده مؤثره (3.2.S)

S.1 General information
S.2 Manufacture
S.3 Characterisation
S.4 Control of drug substance
S.5 Reference standards
S.6 Container closure system
S.7 Stability

Module 3: Quality, drug product (3.2.P)ماژول 3: کیفیت، فرآورده دارویی (3.2.P)

P.1 Description and composition
P.2 Pharmaceutical development
P.3 Manufacture
P.4 Control of excipients
P.5 Control of drug product
P.6 Reference standards
P.7 Container closure system
P.8 Stability

Module 4: Nonclinical study reportsماژول 4: گزارش‌های مطالعات غیربالینی

Pharmacology, pharmacokinetics and toxicology reports

Module 5: Clinical study reportsماژول 5: گزارش‌های مطالعات بالینی

Biopharmaceutic, pharmacokinetic, efficacy and safety study reports

ICH guidelinesراهنماهای ICH

Code	Subject
Q1A(R2)	Stability testing of new drug substances and products
Q1B	Photostability testing
Q2(R2)	Validation of analytical procedures
Q3A(R2)	Impurities in new drug substances
Q3B(R2)	Impurities in new drug products
Q3C	Residual solvents
Q3D	Elemental impurities
Q6A	Specifications for chemical substances and products
Q7	Good manufacturing practice for active ingredients
Q8(R2)	Pharmaceutical development
Q9(R1)	Quality risk management
Q10	Pharmaceutical quality system
Q11	Development and manufacture of drug substances
Q12	Product lifecycle management
Q13	Continuous manufacturing
Q14	Analytical procedure development
M4	The Common Technical Document
M7	Mutagenic impurities
M9	Biopharmaceutics Classification System-based biowaivers
M10	Bioanalytical method validation

Study

Storage condition

Minimum data at submission

Long-term

25 °C ± 2 °C / 60% RH ± 5% | 30 °C ± 2 °C / 65% RH ± 5%

12 months

Intermediate

30 °C ± 2 °C / 65% RH ± 5%

6 months

Accelerated

40 °C ± 2 °C / 75% RH ± 5%

6 months