| Nr. | Title |
| |
| 3084 | Application Form: Module 1.2 Application form - updated version - May 2008 |
| 3085 | Module 1.2 Application form (May 2008) |
| 3086 | Module 1.2 Homeopathic application form (December 2005) |
| 3087 | User guide for the application form (March 2005) |
| 3088 | Notice to Applicants, Volume 2B - Questions and Answers (February 2008) |
| 3090 | Notice to Applicants, Volume 2B - Electronic Common Technical Document (eCTD) |
| 3095 | Guidance on paper submission with eCTD version 1.0 (February 2006) |
| 3097 | Change Control Process for European eCTD Standards - v1.1 (December 2006) |
| 3099 | Guideline on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures (Revision 4, February 2008) |
| 3100 | Guideline on the “2nd step”, when the Competent Authority has to take into account the effect of the PMF/VAMF certification on the concerned medicinal product(s). |
| 3101 | Annex |
| 3116 | Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products |
| 3117 | GUIDELINE ON PRODUCTION AND QUALITY OF MONOCLONAL ANTIBODIES AND RELATED SUBSTANCES |
| 3118 | GUIDELINE ON POTENCY TESTING OF CELL BASED IMMUNOTHERAPY
MEDICINAL PRODUCTS FOR THE TREATMENT OF CANCER |
| 3119 | GUIDELINE ON THE QUALITY OF BIOLOGICAL ACTIVE SUBSTANCES PRODUCED BY STABLE TRANSGENE EXPRESSION IN HIGHER PLANTS |
| 3120 | GUIDELINE ON DEVELOPMENT AND MANUFACTURE OF
LENTIVIRAL VECTORS |
| 3121 | NOTE FOR GUIDANCE ON PRODUCTION AND QUALITY CONTROL OF ANIMAL IMMUNOGLOBULINS AND IMMUNOSERA FOR HUMAN USE |
| 3123 | NOTE FOR GUIDANCE ON THE QUALITY, PRECLINICAL AND CLINICAL ASPECTS OF GENE TRANSFER MEDICINAL PRODUCTS |
| 3124 | NOTE FOR GUIDANCE ON
QUALITY OF BIOTECHNOLOGICAL PRODUCTS: DERIVATION AND
CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF
BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS |
| 3125 | CPMP POSITION STATEMENT ON DNA AND HOST CELL PROTEINS (HCP) IMPURITIES, ROUTINE TESTING VERSUS VALIDATION STUDIES |
| 3128 | PRODUCTION AND QUALITY CONTROL OF
MEDICINAL PRODUCTS DERIVED BY
RECOMBINANT DNA TECHNOLOGY |
| 3131 | USE OF TRANSGENIC ANIMALS IN THE
MANUFACTURE OF BIOLOGICAL MEDICINAL
PRODUCTS FOR HUMAN USE |
| 3132 | PRODUCTION AND QUALITY CONTROL OF
CYTOKINE PRODUCTS DERIVED BY
BIOTECHNOLOGICAL PROCESSES |
| 3133 | NOTE FOR GUIDANCE ON
SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR
BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS |
| 3134 | TESTS ON SAMPLES OF BIOLOGICAL ORIGIN |
| 3135 | GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING
BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES |
| 3136 | GUIDELINE ON
SIMILAR BIOLOGICAL MEDICINAL PRODUCTS |
| 3137 | NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS
SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS |
| 3139 | NOTE FOR GUIDANCE ON PLASMA-DERIVED MEDICINAL PRODUCTS |
| 3140 | GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER
FILE (PMF) Revision 1 |
| 3141 | ANNEXES TO
GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1 |
| 3142 | GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF
ANTIBODY TO HUMAN IMMUNODEFICIENCY VIRUS (ANTI-HIV) IN PLASMA POOLS |
| 3143 | GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) IN PLASMA POOLS |
| 3145 | GUIDELINE ON THE REQUIREMENTS FOR PLASMA MASTER FILE (PMF) CERTIFICATION |
| 3146 | GUIDELINE ON ASSESSING THE RISK FOR VIRUS TRANSMISSION
– NEW CHAPTER 6 OF THE NOTE FOR GUIDANCE ON PLASMADERIVED
MEDICINAL PRODUCTS |
| 3147 | GUIDELINE ON THE INVESTIGATION OF MANUFACTURING
PROCESSES FOR PLASMA-DERIVED MEDICINAL PRODUCTS
WITH REGARD TO VCJD RISK |
| 3149 | CPMP POSITION STATEMENT ON WEST NILE VIRUS AND PLASMA-DERIVED MEDICINAL PRODUCTS |
| 3150 | CPMP POSITION STATEMENT NON-REMUNERATED AND REMUNERATED DONORS: SAFETY AND SUPPLY OF PLASMA-DERIVED MEDICINAL PRODUCTS |
| 3151 | PLASMA-DERIVED MEDICINAL PRODUCTS: POSITION PAPER ON
ALT TESTING |
| 3152 | GUIDELINE ON DOSSIER STRUCTURE AND CONTENT OF MARKETING
AUTHORISATION APPLICATIONS FOR INFLUENZA VACCINES DERIVED FROM
STRAINS WITH A PANDEMIC POTENTIAL FOR USE OUTSIDE OF THE CORE
DOSSIER CONTEXT |
| 3153 | GUIDELINE ON ADJUVANTS IN VACCINES FOR HUMAN USE |
| 3154 | EXPLANATORY NOTE ON IMMUNOMODULATORS FOR THE GUIDELINE ON
ADJUVANTS IN VACCINES FOR HUMAN USE |
| 3155 | GUIDELINE ON DOSSIER STRUCTURE AND CONTENT FOR PANDEMIC INFLUENZA VACCINE MARKETING AUTHORISATION APPLICATION |
| 3156 | GUIDELINE ON SUBMISSION OF MARKETING AUTHORISATION APPLICATIONS FOR PANDEMIC INFLUENZA VACCINES THROUGH THE CENTRALISED PROCEDURE |
| 3157 | GUIDELINE ON REQUIREMENTS FOR VACCINE ANTIGEN MASTER
FILE (VAMF) CERTIFICATION |
| 3158 | CPMP POSITION STATEMENT ON THE QUALITY OF WATER USED IN THE PRODUCTION OF VACCINES FOR PARENTERAL USE |
| 3159 | GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A
VACCINE ANTIGEN MASTER FILE (VAMF) |
| 3160 | CELL CULTURE INACTIVATED INFLUENZA VACCINES ANNEX TO NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES (CPMP/BWP/214/96) |
| 3161 | POINTS TO CONSIDER ON THE DEVELOPMENT OF LIVE ATTENUATED INFLUENZA VACCINES |
| 3162 | NOTE FOR GUIDANCE ON THE DEVELOPMENT OF VACCINA VIRUS BASED VACCINES AGAINST SMALLPOX |
| 3163 | POINTS TO CONSIDER ON THE REDUCTION, ELIMINATION OR SUBSTITUTION OF THIOMERSAL IN VACCINES |
| 3164 | Public Statement on the Evaluation of Bovine Spongiform Encephalopathies (BSE)-risk via the use of materials of bovine origin in or during the manufacture of vaccines |
| 3165 | NOTE FOR GUIDANCE ON PHARMACEUTICAL AND BIOLOGICAL ASPECTS OF COMBINED VACCINES |
| 3166 | NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES |
| 3167 | QUALITY OF BIOTECHNOLOGICAL PRODUCTS:
STABILITY TESTING OF BIOTECHNOLOGICAL/
BIOLOGICAL PRODUCTS |
| 3168 | Guidance on a new therapeutic indication for a well established substance (November 2007) |
| 3169 | DEVELOPMENT PHARMACEUTICS FOR BIOTECHNOLOGICAL AND BIOLOGICAL PRODUCTS (CPMP/BWP/328/99) ANNEX TO NOTE FOR GUIDANCE ON DEVELOPMENT PHARMACEUTICS (CPMP/QWP/155/96) |
| 3170 | GUIDELINE ON POTENCY LABELLING FOR INSULIN ANALOGUE CONTAINING PRODUCTS WITH PARTICULAR REFERENCE TO THE USE OF “INTERNATIONAL UNITS” OR “UNITS” |
| 3171 | Guidance on elements required to support the significant benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11 years) marketing protection period (November 2007) |
| 3172 | CORE SPC FOR PANDEMIC INFLUENZA VACCINES |
| 3173 | GUIDELINE ON PHARMACEUTICAL ASPECTS OF THE PRODUCT INFORMATION FOR HUMAN VACCINES |
| 3174 | NOTE FOR GUIDANCE ON THE WARNING ON TRANSMISSIBLE AGENTS IN SUMMARY OF PRODUCT CHARACTERISTICS (SPCs) AND PACKAGE LEAFLETS FOR PLASMA-DERIVED MEDICINAL PRODUCTS |
| 3175 | GUIDANCE ON THE DESCRIPTION OF COMPOSITION OF PEGYLATED (CONJGATED) PROTEINS IN THE SPC |
| 3176 | GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS |
| 3177 | NOTE FOR GUIDANCE ON THE USE OF BOVINE SERUM IN THE MANUFACTURE OF HUMAN BIOLOGICAL MEDICINAL PRODUCTS |
| 3178 | POSITION PAPER ON VIRAL SAFETY OF ORAL POLIOVIRUS VACCINE (OPV) |
| 3179 | NOTE FOR GUIDANCE ON
Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin |
| 3180 | NOTE FOR GUIDANCE ON VIRUS VALIDATION STUDIES: THE DESIGN, CONTRIBUTION AND INTERPRETATION OF STUDIES VALIDATING THE INACTIVATION AND REMOVAL OF VIRUSES |
| 3181 | FIRST CASES OF BSE IN USA AND CANADA: RISK ASSESSMENT OF RUMINANT MATERIALS ORIGINATING FROM USA AND CANADA |
| 3182 | NOTE FOR GUIDANCE ON GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS AMENDMENTS TO SECTIONS 6.2 AND 6.3 |
| 3183 | NOTE FOR GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS (EMEA/410/01 REV. 2 - OCTOBER 2003) ADOPTED BY THE COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) AND BY THE COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) |
| 3184 | POSITION PAPER ON RE-ESTABLISHMENT OF WORKING SEEDS AND WORKING CELL BANKS USING TSE COMPLIANT MATERIALS |
| 3185 | PUBLIC REPORT RISK AND REGULATORY ASSESSMENT OF LACTOSE AND OTHER PRODUCTS PREPARED USING CALF RENNET |
| 3186 | JOINT CPMP/CVMP NOTE FOR GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS - EXPLANATORY NOTE FOR MEDICINAL PRODUCTS FOR HUMAN USE IN THE SCOPE OF THE GUIDELINE |
| 3187 | QUESTIONS AND ANSWERS ON BOVINE SPONGIFORM ENCEPHALOPATHIES (BSE) AND VACCINES |
| 3188 | PUBLIC STATEMENT ON THE EVLAUATION OF SPONGIFORM ENCEPHALOPATHIES (BSE)-RISK VIA THE USE OF MATERIALS OF BOVINE ORIGIN IN OR DURING THE MANUFACTURE OF VACCINES |
| 3189 | GELATIN FOR USE IN PHARMACEUTICALS: EXPLANATORY NOTE (13 DECEMBER 2000) ON THE MANUFACTURE OF GELATIN IN RELATIONSHIP TO THE CPMP NOTE FOR GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPAHTY AGENTS VIA MEDICINAL PRODUCTS (CPMP/BWP/1230/98 REV 1) |
| 3190 | COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION STATEMENT ON POLYSORBATE 80 |
| 3191 | COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION PAPER ON PRODUCTION OF TALLOW DERIVATIVES FOR USE IN PHARMACEUTICALS |
| 3192 | GUIDELINE ON THE INVESTIGATION OF MANUFACTURING
PROCESSES FOR PLASMA-DERIVED MEDICINAL PRODUCTS
WITH REGARD TO VCJD RISK |
| 3193 | CHMP POSITION STATEMENT ON CREUTZFELDT-JACOB DISEASE and PLASMA-DERIVED AND URINE-DERIVED MEDICINAL PRODUCTS |
| 3194 | GUIDELINE ON ENVIRONMENTAL RISK ASSESSMENTS FOR MEDICINAL
PRODUCTS CONSISTING OF, OR CONTAINING, GENETICALLY MODIFIED
ORGANISMS (GMOs) |
| 3195 | GMP Inspection report - Community format |
| 3196 | Guidance for Industry
Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay |
| 3197 | Guidance for Industry
“Lookback” for
Hepatitis C Virus (HCV):
Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients
Based on Donor Test Results
Indicating Infection with HCV |
| 3198 | Guidance for Industry
Blood Establishment Computer System Validation in the User’s Facility
DRAFT GUIDANCE |
| 3199 | Guidance for Industry
Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes |
| 3200 | Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle |
| 3201 | Guidance for Industry and FDA Review Staff
Collection of Platelets by Automated Methods |
| 3203 | Guidance for Industry
Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay |
| 3204 | FEDERAL REGISTER 21 CFR Part 866
[Docket No. 2007N–0294]
Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay |
| 3205 | Guidance for Industry and FDA Staff
Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions |
| 3206 | Guidance for Industry, FDA,
and Foreign Governments:
FY 2009 Medical Device User Fee
Small Business Qualification
and Certification |
| 3207 | Draft Guidance for Industry and FDA Staff
In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions |
| 3208 | Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle |
| 3209 | FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle; Final Rule |
| 3211 | Guidance for Industry
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) |
| 3212 | Guidance for Industry
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Small Entity Compliance Guide |
| 3213 | Guidance for Industry
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials |
| 3214 | FEDERAL REGISTER: Revision of the Requirements for Live Vaccine Processing; Direct Final Rule |
| 3215 | Guidance for Industry
Considerations for Plasmid DNA Vaccines for Infectious Disease Indications |
| 3235 | NOTICE TO APPLICANTS Volume 6A
VETERINARY MEDICINAL PRODUCTS General Information |
| 3236 | NOTICE TO APPLICANTS Volume 6C GUIDELINE ON THE PACKAGING INFORMATION OF VETERINARY MEDICINAL PRODUCTS AUTHORISED BY THE COMMUNITY |
| 3237 | Ethical considerations for clinical trials on medicinal products conducted with the paediatric population |
| 3238 | Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP |
| 3240 | Marketed Unapproved Drugs |
| 3241 | PET Drug Products - CGMP |
| 3242 | Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products |
| 3246 | EC/312/2008 Commission Regulation (EC) No 312/2008 of 3 April 2008 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate |
| 3247 | Annex 20: Quality Risk Management |
| 3284 | GUIDANCE FOR EXCHANGE OF GCP INSPECTION REPORTS ACCORDING TO
DIRECTIVE 2001/20/EC ARTICLE 15 (2) |
| 3285 | GUIDANCE FOR THE COMMUNICATION ON GOOD CLINICAL PRACTICE INSPECTIONS AND FINDINGS |
| 3286 | GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS |
| 3287 | Annex I TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Investigator site |
| 3288 | Annex II TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Clinical Laboratories |
| 3289 | Annex III TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Computer Systems |
| 3290 | Annex IV TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Sponsor and CRO |
| 3291 | GUIDANCE FOR THE PREPARATION OF GOOD CLINICAL PRACTICE INSPECTIONS |
| 3292 | GUIDANCE FOR THE PREPARATION OF GOOD CLINICAL PRACTICE INSPECTION REPORTS |
| 3293 | Guideline 2008/C168/02 on the data fields from the European clinical trials database (EudraCT) that may be included in the European database on Medicinal Products |
| 3295 | Q4B Evaluation and
Recommendation of
Pharmacopoeial Texts for Use
in the ICH Regions |
| 3296 | Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the
ICH Regions
Annex 1
Residue on Ignition/Sulphated Ash
General Chapter |
| 3298 | Indexing Structured Product Labeling |
| 3299 | Current Good Manufacturing Practice for Phase 1 Investigational Drugs |
| 3300 | Submission of Documentation in applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes |
| 3301 | Q4B Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the ICH Regions
Annex 4A: Microbiological Examination of
Non-Sterile Products: Microbial Enumeration Tests
General Chapter |
| 3302 | Q4B Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the ICH Regions
Annex 4B: Microbiological Examination of
Non-Sterile Products: Tests for Specified
Micro-organisms General Chapter |
| 3303 | Q4B Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the ICH Regions
Annex 4C: Microbiological Examination of
Non-Sterile Products: Acceptance Criteria for
Pharmaceutical Preparations and Substances for
Pharmaceutical Use General Chapter |
| 3304 | Q4B Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the ICH Regions
Annex 5: Disintegration Test General Chapter |
| 3305 | 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products. (Official Journal L 168, 30/6/2009, p. 33 - 34). |
| 3308 | Annex 1: Clinical Trial Application Form |
| 3309 | Concept Paper on the Development of a Guideline on Setting Specifications for Related Impurities in Antibiotics |
| 3310 | Q4B Annex 5 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter Q4B Annex 5 |
| 3325 | COMPLIANCE POLICY GUIDE Sec. 410.100 Finished Dosage Form Drug Products in Bulk Containers - Applications of Current Good Manufacturing Practice Regulations (CPG 7132a.06) |
| 3326 | Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices |
| 3327 | Principles of In Vitro Diagnostic (IVD) Medical Devices Classification |
| 3328 | SummalY Technical Documentation for Demonstrating Confonnity to
the Essential Principles of Safety and Performance ofMedical Devices
(STED) |
| 3331 | Annex 1 - Contract between Auditor and the API Compliance Institute |
| 3332 | Annex 2 - Agreement on Audit Execution |
| 3333 | Annex 3 - Secrecy Agreement |
| 3335 | Standardised Letters related to Shared 3rd Party Audits: Letter 1 - Letter to the Manufacturing Authorisation Holder |
| 3336 | Standardised Letters related to Shared 3rd Party Audits: Letter 2 - Letter to the API Manufacturer |
| 3337 | Standardised Letters related to Shared 3rd Party Audits: Letter 3 - Letter from the API Manufacturer to the customer |
| 3338 | Annex 5 - Feedback Form |
| 3339 | APIC - Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers - integrating GMP (ICH Q7a) into ISO (9001:2000), September 2005 |
| 3350 | Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products |
| 3353 | Process Validation: General Principles and Practices |
| 3355 | 2008/C 243/09 Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies
(Official Journal C 243/1, 2008) |
| 3356 | Annex V GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Phase I Units |
| 3357 | Annex VII TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL
PRACTICE INSPECTIONS: Bioanalytical part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials |
| 3358 | RECOMMENDATION ON INSPECTION PROCEDURES FOR THE VERIFICATION OF GOOD CLINICAL PRACTICE COMPLIANCE |
| 3359 | PROCEDURE FOR STANDARDISATION OF GCP INSPECTION ENTRIES IN EUDRACT |
| 3360 | RECOMMENDATIONS ON THE QUALIFICATIONS OF INSPECTORS VERIFYING COMPLIANCE IN CLINICAL TRIALS WITH THE PROVISIONS OF GOOD CLINICAL PRACTICE |
| 3361 | Guidelines on good clinical practice (ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95) |
| 3375 | Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information |
| 3376 | Residual Solvents in Drug Products Marketed in the United States |
| 3377 | Q8(R2) Pharmaceutical Development Revision 2 |
| 3382 | Annex 11: Computerised Systems |
| 3384 | Annex 4: Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products |
| 3386 | Chapter 4: Documentation Draft |
| 3399 | Q4B Annex 2: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter |
| 3400 | Q4B Annex 3: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter |
| 3401 | Q4B Annex 4A: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter |
| 3402 | Q4B Annex 4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter |
| 3403 | Q4B Annex 4C: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter |
| 3404 | Q4B Annex 6: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter |
| 3405 | Q4B Annex 7: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter |
| 3406 | Q4B Annex 8: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter |
| 3407 | Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - General |
| 3408 | Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Equipment |
| 3409 | Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Control of Components and Drug Product Containers and Closures |
| 3410 | Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Packaging and Labeling Control |
| 3411 | Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Laboratory Controls |
| 3412 | Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Records and Reports |
| 3413 | Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Production and Process Control |
| 3426 | Guideline on Active Substance Master File Procedure (CPMP/QWP/ 227/02 Rev. 2) |
| 3427 | Guideline on Summary of Requirements for Active Substances in the Quality Part of the Dossier (CHMP/QWP/297/97 Rev. 1) |
| 3428 | Guideline on Active Substance Master File Procedure (CPMP/QWP/227/02 Rev. 1) |
| 3429 | Guideline on the Chemistry of New Active Substances (CPMP/QWP/130/96 Rev. 1) |
| 3430 | Investigation of Chiral Active Substances (3CC29A) |
| 3431 | Chemistry of Active Substances (3AQ5A) |
| 3433 | Process Validation (CPMP/QWP/848/96) |
| 3434 | Annex II to Note for Guidance on Process Validation: - Non-Standard Processes (CPMP/QWP/2054/03) |
| 3435 | Note for Guidance on Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products (CPMP/QWP/159/01) |
| 3436 | Note for Guidance on Manufacture of the Finished Dosage Form (CPMP/QWP/486/95) |
| 3437 | Annex to Note for Guidance on Manufacture of the finished dosage Form: Start of Shelf-Life of the Finished Dosage Form (CPMP/QWP/072/96) |
| 3438 | The use of Ionizing Radiation in the Manufacture of Medicinal Products 3AQ4A |
| 3440 | Guideline on the Limits of genotoxic impurities (CPMP/SWP/5199/02 EMEA/CHMP/QWP/251344/2006) |
| 3441 | Guideline on Control of Impurities of Pharmacopoeial Substances (CPMP/QWP/ 1529/04) |
| 3442 | Note for Guidance on Impurities in new Drug Products (ICH Q3B(R2))(CPMP/ICH/2738/99) |
| 3443 | Note for Guidance on Impurities Testing: Impurities in New Drug Substances (ICH Q3A (R2)) (CPMP/ICH/2737/99) |
| 3444 | Note for Guidance on Impurities: Residual Solvents (ICH Q3C(R4)) (CPMP/ICH/283/95) |
| 3445 | Annexes to: CPMP/ICH/283/95 Impurities: Guideline for Residual Solvents & CVMP/VICH/502/99 Guideline on Impurities: Residual Solvents; ANNEX I: SPECIFICATIONS FOR CLASS 1 AND CLASS 2 RESIDUAL SOLVENTS IN ACTIVE SUBSTANCES; ANNEX II: RESIDUES OF SOLVENTS USED IN THE MANUFACTURE OF FINISHED PRODUCTS |
| 3447 | Setting Specifications for Related Impurities in Antibiotics CHMP/CVMP/QWP/136351/08 |
| 3448 | ICH Topic Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions |
| 3449 | ICH Topic Q4B Annex 1
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter |
| 3450 | ICH Topic Q4B Annex 2
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter |
| 3451 | ICH Topic Q4B Annex 3
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter |
| 3452 | ICH Topic Q4B Annex 4 A
Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter |
| 3453 | ICH Topic Q4B Annex 4 B
Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter |
