| Nr. | Title |
| |
| 2813 | ORA Quality Manual |
| 2814 | Guidance for Industry
Errors and Accidents Regarding
Saline Dilution of Samples Used for
Viral Marker Testing |
| 2817 | GUIDELINE FOR
QUALITY ASSURANCE IN
BLOOD ESTABLISHMENTS |
| 2818 | DRAFT POINTS TO CONSIDER IN THE
DESIGN AND IMPLEMENTATION OF FIELD TRIALS FOR
BLOOD GROUPING REAGENTS AND ANTI-HUMAN GLOBULIN |
| 2819 | DRAFT
RECOMMENDED METHODS FOR
BLOOD GROUPING REAGENTS EVALUATION |
| 2820 | DRAFT
RECOMMENDED METHODS FOR
EVALUATING POTENCY, SPECIFICITY, AND REACTIVITY
OF ANTI-HUMAN GLOBULIN |
| 2821 | Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors) |
| 2825 | Guideline for the Uniform Labeling of Blood and Blood Components |
| 2828 | Guidance for Industry
Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
DRAFT GUIDANCE |
| 2829 | Guidance for Industry
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) |
| 2830 | Guidance for Industry
Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events |
| 2831 | Guidance for Industry
Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During
Follow-up of Patients in Clinical
Trials Using Retroviral Vectors |
| 2834 | Guidance for Industry
Guidance for Human Somatic Cell
Therapy and Gene Therapy |
| 2835 | Draft Guidance for Industry,
Clinical Laboratories, and FDA
Staff
In Vitro Diagnostic Multivariate
Index Assays
DRAFT GUIDANCE |
| 2839 | Medicinal Gases: Pharmaceutical documentation (CPMP/QWP/1719/00 Rev 1) |
| 2840 | Q9 Quality Risk Management |
| 2841 | FEDERAL REGISTER Medical Devices; Hematology and
Pathology Devices; Reclassification of
Automated Blood Cell Separator
Device Operating by Filtration
Principle from Class III to Class II |
| 2842 | Guidance for Industry and FDA Staff
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use |
| 2844 | Adopted Guideline (Radiopharmaceuticals) |
| 2845 | Draft Guideline (Radiopharmaceuticals) |
| 2846 | FEDERAL REGISTER Medical Devices; Immunology and
Microbiology Devices; Classification of
the West Nile Virus IgM Capture Elisa
Assay |
| 2847 | Concept paper |
| 2848 | Human cell-based medicinal products |
| 2849 | Concept Paper for the revision of Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products |
| 2850 | Gene Therapy Product Quality Aspects in the Production of Vectors and Genetically Modified Somatic Cells |
| 2851 | The replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products |
| 2852 | Concept Paper: Revision of the Note for guidance on Plasma-Derived Medicinal Products |
| 2853 | Draft : Revision of CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products |
| 2855 | Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture |
| 2857 | Guidance for FDA
Reviewers
Premarket Notification
Submissions for Transfer Sets
(Excluding Sterile Connecting
Devices) |
| 2858 | Guidance for FDA
Reviewers
Premarket Notification
Submissions for Empty Containers for the Collection and Processing of Blood and
Blood Components |
| 2859 | Guidance for Industry
Revised Recommendations Regarding
Invalidation of Test Results of Licensed
and 510(k) Cleared Bloodborne
Pathogen Assays Used to Test Donors |
| 2862 | COMPLIANCE POLICY GUIDE Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02) |
| 2864 | COMPLIANCE POLICY GUIDES - Foreword |
| 2867 | Guidance for Industry
Source Animal, Product, Preclinical,
and Clinical Issues Concerning the Use
of Xenotransplantation Products in
Humans |
| 2869 | Guidance for Industry
Precautionary Measures to Reduce
the Possible Risk of Transmission of
Zoonoses by Blood and Blood
Products from Xenotransplantation
Product Recipients and Their
Intimate Contacts
DRAFT GUIDANCE |
| 2870 | PHS GUIDELINE ON
INFECTIOUS DISEASE ISSUES IN XENOTRANSPLANTATION |
| 2873 | Guidance For Industry
Public Health Issues Posed by the
Use of Nonhuman Primate
Xenografts in Humans |
| 2874 | Points to Consider in the Characterization of Cell Lines Used
to Produce Biologicals |
| 2875 | COMPLIANCE PROGRAM GUIDANCE MANUAL
Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
7341.002 |
| 2876 | Compliance Program
Chapter 41 - Therapeutic Products
Inspection of Tissue Establishments
7341.002A |
| 2877 | Compliance Program Guidance Manual
Chapter 42 - Blood and Blood Products
Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001 |
| 2878 | Compliance Program Guidance Manual
Chapter 42 – Blood and Blood Products
Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors - 7342.002 |
| 2879 | COMPLIANCE PROGRAM GUIDANCE MANUAL
Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
7342.007 Addendum |
| 2880 | Compliance Program
Chapter 42 - Blood and Blood Products
Inspection of Licensed Viral Marker Test Kits
7342.008 |
| 2881 | Compliance Program Guidance Manual
Chapter – 45 Biological Drug Products
Inspection of Biological Drug Products (CBER)
7345.848 |
| 2882 | Guidance for Industry
Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines |
| 2883 | Guidance for Industry
Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines |
| 2884 | Guidance for Industry
Characterization and Qualification of Cell Substrates and Other Guidance for Industry Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications
DRAFT GUIDANCE |
| 2886 | Guidance for Industry
Considerations for Developmental
Toxicity Studies for Preventive and
Therapeutic Vaccines for Infectious
Disease Indications |
| 2888 | FEDERAL REGISTER Biological Products; Bacterial
Vaccines and Toxoids; Implementation
of Efficacy Review |
| 2889 | FEDERAL REGISTER Biological Products; Bacterial
Vaccines and Toxoids; Implementation
of Efficacy Review; Anthrax Vaccine
Adsorbed; Final Order |
| 2890 | COMPLIANCE POLICY GUIDES - Introduction |
| 2891 | COMPLIANCE POLICY GUIDE Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention (CPG 7150.13) |
| 2892 | Guidance for Industry
FDA Review of Vaccine Labeling
Requirements for Warnings, Use
Instructions, and Precautionary
Information |
| 2893 | COMPLIANCE POLICY GUIDE Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices (CPG 7150.16) Page 5 |
| 2894 | Guidance for Industry
Postmarketing Safety Reporting
for Human Drug and Biological
Products Including Vaccines
DRAFT GUIDANCE |
| 2896 | Guidance for Industry
Considerations for Developmental
Toxicity Studies for Preventive and
Therapeutic Vaccines for Infectious
Disease Indications |
| 2897 | Guidance for Industry
Content and Format of Chemistry,
Manufacturing and Controls
Information and Establishment
Description Information for a Vaccine
or Related Product |
| 2898 | Guidance for Industry
How to Complete the Vaccine
Adverse Event Reporting System
Form (VAERS-1) |
| 2901 | PIC/S RECOMMENDATION ON RISK-BASED INSPECTION PLANNING (PI 037-1) |
| 2902 | FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling |
| 2903 | FEDERAL REGISTER Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation |
| 2904 | Q10 Pharmaceutical Quality System |
| 2905 | Guidance for Industry
Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container |
| 2906 | FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container |
| 2907 | Guidance for Industry
Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors
Who Were Tested For Communicable Diseases Using Pooled Specimens or Diagnostic Tests |
| 2908 | Guidance for Industry
Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
DRAFT GUIDANCE |
| 2909 | Guidance for Industry and FDA Staff:
Minimal Manipulation of Structural Tissue
Jurisdictional Update |
| 2910 | Guidance for Industry
Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements |
| 2911 | FEDERAL REGISTER Eligibility Determination for Donors of
Human Cells, Tissues, and Cellular and
Tissue-Based Products; Correction |
| 2912 | FEDERAL REGISTER Eligibility Determination for Donors of
Human Cells, Tissues, and Cellular and
Tissue-Based Products; Final Rule and
Notice |
| 2913 | Guidance for Industry
MedWatch Form FDA 3500A:
Mandatory Reporting of Adverse
Reactions Related to Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps) |
| 2914 | FEDERAL REGISTER Current Good Tissue Practice for Human
Cell, Tissue, and Cellular and Tissue-
Based Product Establishments; Inspection
and Enforcement; Final Rule |
| 2915 | Guidance for Industry
Recommendations for Obtaining a
Labeling Claim for Communicable
Disease Donor Screening Tests Using
Cadaveric Blood Specimens from
Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products
(HCT/Ps) |
| 2916 | FEDERAL REGISTER Human Cells, Tissues, and Cellular and
Tissue-Based Products; Establishment
Registration and Listing; Correction |
| 2917 | COMPLIANCE POLICY GUIDE Sec. 140.500 Metric Declarations of Quantity of Contents on Product Labels (CPG 7150.17) |
| 2918 | COMPLIANCE POLICY GUIDE Sec. 300.100 Inspection of Manufacturers of Device Components (CPG 7124.15) |
| 2919 | FEDERAL REGISTER Human Cells, Tissues, and Cellular and
Tissue-Based Products; Establishment
Registration and Listing; Final rule |
| 2921 | FEDERAL REGISTER Combination Products Containing Live
Cellular Components; Public Hearing |
| 2922 | Guidance for Industry
Validation of Procedures for
Processing of Human Tissues
Intended for Transplantation |
| 2923 | Human Cells or Tissues Intended for Transplant Into a Human Recipient That Have Ex-vivo Contact With Live Nonhuman Animal Cells, Tissues, or Organs Letter |
| 2924 | COMPLIANCE POLICY GUIDE Sec. 400.100 Drugs, Human - Failure to Register (CPG 7132.07) |
| 2925 | Guidance for Industry Availability of Licensed Donor
Screening Tests Labeled for Use with Cadaveric Blood Specimens |
| 2926 | Guidance for Industry Screening and Testing of Donors of
Human Tissue Intended for Transplantation |
| 2927 | COMPLIANCE POLICY GUIDE Sec. 400.200 Consistent Application of CGMP Determinations (CPG 7132.12) |
| 2928 | COMPLIANCE POLICY GUIDE Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15) |
| 2929 | COMPLIANCE POLICY GUIDE Sec. 400.900 Class I Recalls of Prescription Drugs (CPG 7132.01) |
| 2930 | Guidance for Industry
CGMP for Phase 1 Investigational Drugs |
| 2931 | Guidance for Industry
Pharmacogenomic Data
Submissions |
| 2933 | Guidance for Industry
Developing Medical Imaging Drug and
Biological Products
Part 1: Conducting Safety Assessments |
| 2934 | Guidance for Industry
Developing Medical Imaging Drug and
Biological Products
Part 2: Clinical Indications |
| 2935 | Guidance for Industry
Developing Medical Imaging Drug and
Biological Products
Part 3: Design, Analysis, and
Interpretation of Clinical Studies |
| 2936 | Guidance for Industry
Information Program on
Clinical Trials for Serious or
Life-Threatening Diseases and
Conditions
DRAFT GUIDANCE |
| 2938 | Guidance for Reviewers
Instructions and Template for
Chemistry, Manufacturing, and
Control (CMC) Reviewers of Human
Somatic Cell Therapy Investigational New Drug Applications (INDs) |
| 2939 | Guidance for Industry
Exposure-Response Relationships — Study
Design, Data Analysis, and Regulatory
Applications |
| 2941 | Guidance for Industry
Providing Regulatory Submissions to
CBER in Electronic Format —
Investigational New Drug Applications
(INDs) |
| 2942 | Guidance for Clinical
Trial Sponsors
On the Establishment and Operation
of Clinical Trial Data Monitoring
Committees |
| 2943 | Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information |
| 2944 | Guidance for Industry
Acceptance of Foreign
Clinical Studies |
| 2945 | Guidance for Industry
Submitting and Reviewing Complete
Responses to Clinical Holds |
| 2946 | Guidance for Industry
Q & A
Content and Format of INDs for Phase 1 Studies
of Drugs, Including
Well-Characterized, Therapeutic,
Biotechnology-Derived Products |
| 2947 | Guidance for Industry
Content and Format of
Investigational New Drug
Applications (INDs) for Phase 1
Studies of Drugs, Including
Well-Characterized, Therapeutic,
Biotechnology-derived Products |
| 2949 | Guidance for Industry
Submission of Abbreviated Reports and
Synopses in Support of
Marketing Applications |
| 2951 | Guidance for Industry
Providing Clinical Evidence of
Effectiveness for Human Drugs and
Biological Products |
| 2952 | INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
M4: COMMON TECHNICAL DOCUMENT
MODULES IIA, IIB NONCLINICAL
MODULE III, QUALITY
MODULES IV, NONCLINICAL
MODULE V, EFFICACY |
| 2953 | International Conference on
Harmonisation; Guidance on the
Duration of Chronic Toxicity Testing in
Animals (Rodent and Nonrodent
Toxicity Testing); Availability |
| 2954 | International Conference on
Harmonisation; Guidance on Statistical
Principles for Clinical Trials;
Availability |
| 2955 | International Conference on
Harmonisation; Guidance on Ethnic
Factors in the Acceptability of Foreign
Clinical Data; Availability |
| 2966 | Eudralex Volume 8 - Maximum residue limits - Veterinary Medicinal Products |
| 2970 | Q10 PHARMACEUTICAL QUALITY
SYSTEM |
| 3081 | Volume 9a - Pharmacovigilance for Medicinal Products for Human Use - With the application of the new pharmacovigilance legislation as from July 2012 Volume 9A is replaced by the good pharmacovigilance practice guidelines(GVP) released by the European Medicines Agency. However, until the availability of the respective GVP modules Volume 9A remains the reference. |
| 3082 | Volume 9b - Pharmacovigilance for Medicinal Products for Veterinary Use |
| 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 eSubmission Standards - v2.1 (May 2011) |
| 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
(CPMP/ICH/365/96) |
| 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. 3) (2011/C 73/01) |
| 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 |
