Regulator resource library

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Guideline Clinical Investigation Medicinal Products Treatment Chronic Obstructive Pulmonary Disease Copd

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Investigation Chiral Active Substances

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Guideline Clinical Investigation Anti Anginal Medicinal Products Stable Angina Pectoris

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Clinical Investigation Corticosteroids Intended USE Skin

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Medicinal Products NON Steroidal Anti Inflammatory Compounds Treatment Chronic Disorders

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Replacement Chlorofluorocarbons CFC Metered Dose Inhalation Products

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Radiopharmaceuticals Based Monoclonal Antibodies

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Gene Therapy Product Quality Aspects Production Vectors AND Genetically Modified Somatic Cells

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Production AND Quality Control Cytokine Products Derived Biotechnological Processes

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Guideline Comparability Biotechnology Derived Medicinal Products After Change Manufacturing Process NON Clinical AND Clinical Issues

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Note Guidance Antiarrhythmics

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Reflection Paper NON Clinical AND Clinical Development Similar Medicinal Products Containing Recombinant Interferon Alfa

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Guideline Clinical Investigation Medicinal Products Indicated Treatment Psoriasis

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Guideline Clinical Development Medicinal Products Treatment Allergic Rhino Conjunctivitis

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Paediatric Addendum Chmp Guideline Clinical Investigation Medicinal Products Treatment Lipid Disorders

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Guideline Plastic Immediate Packaging Materials

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Guideline Development NEW Medicinal Products Treatment Crohns Disease

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Note Guidance Limitations USE Ethylene Oxide Manufacture Medicinal Products

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Guideline Choice NON Inferiority Margin

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Addendum Guideline Antiarrhythmics Atrial Fibrillation AND Atrial Flutter

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Guideline NON Clinical Testing Inadvertent Germline Transmission Gene Transfer Vectors

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Chmp Recommendations Pharmacovigilance Plan Part Risk Management Plan BE Submitted Marketing Authorisation Application Pandemic Influenza Vaccine

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Guideline Investigation Medicinal Products Term AND Preterm Neonate

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Note Guidance Minimising Risk Transmitting Animal Spongiform Encephalopathy Agents Human AND Veterinary Medicinal Products

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Guideline Clinical Investigation Medicinal Products Treatment OR Prevention Diabetes Mellitus

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Guideline Clinical Evaluation Diagnostic Agents

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ICH Guideline Q4B Annex 4B Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Tests Specified Micro Organisms

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ICH Guideline Q4B Annex 4A Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Micro Enumeration

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ICH Topic S 4 Duration Chronic Toxicity Testing Animals Rodent AND NON Rodent Toxicity Testing

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ICH Topic Q5D Quality Biotechnological Products Derivation AND Characterisation Cell Substrates Used Production Biotechnologicalbiological Products

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ICH Topic E 5 R1 Ethnic Factors Acceptability Foreign Clinical Data

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ICH Guideline M3r2 NON Clinical Safety Studies Conduct Human Clinical Trials AND Marketing Authorisation Pharmaceuticals

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Guideline Clinical Investigation Medicinal Products Treatment Urinary Incontinence

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Guideline Development NEW Medicinal Products Treatment Ulcerative Colitis

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Guideline Clinical Development Products Specific Immunotherapy Treatment Allergic Diseases

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Guideline Reporting Results Population Pharmacokinetic Analyses

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Questions AND Answers Document Clinical Development Fixed Combinations Drugs Belonging Different Therapeutic Classes Field Cardiovascular Treatment AND Prevention

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Points Consider Concerning Endpoints Clinical Studies Haematopoeitic Growth Factors Mobilisation Autologous Stem Cells

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Guideline Development Medicinal Products Treatment Alcohol Dependence

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Guideline Clinical Investigation Immunosuppressants Solid Organ Transplantation

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Guideline Requirements Clinical Documentation Orally Inhaled Products OIP

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Guideline Clinical Investigation Medicinal Products Treatment Obsessive Compulsive Disorder

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Guideline Immunogenicity Assessment Monoclonal Antibodies Intended Vivo Clinical USE

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Guideline NON Clinical AND Clinical Development Similar Biological Medicinal Products Containing Recombinant Human Follicle Stimulating Hormone R Hfsh

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Guideline Similar Biological Medicinal Products Containing Interferon Beta

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Guideline Similar Biological Medicinal Products Containing Monoclonal Antibodies NON Clinical AND Clinical Issues

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Guideline NON Clinical AND Clinical Development Similar Biological Medicinal Products Containing Recombinant Human Insulin AND Insulin Analogues

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Guideline Clinical Investigation Medicinal Products Indicated Treatment Panic Disorder

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Guideline Clinical Investigation Medicinal Products Indicated Generalised Anxiety Disorder

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Guideline Clinical Investigation Medicinal Products Treatment Attention Deficit Hyperactivity Disorder Adhd

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Guideline Clinical Investigation Medicinal Products Treatment Psoriatic Arthritis

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Guideline Clinical Investigation Medicinal Products Treatment Asthma

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Guideline Clinical Investigation Medicinal Products Treatment Acute Heart Failure

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Guideline Clinical Evaluation Direct Acting Antiviral Agents Intended Treatment Chronic Hepatitis C

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Guideline Clinical Investigation Medicinal Products Treatment Sepsis

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Guideline Evaluation Medicinal Products Cardiovascular Disease Prevention

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Points Consider Switching Between Superiority AND NON Inferiority

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Appendix 1 Guideline Clinical Evaluation Diagnostic Agents Cpmpewp111998 REV 1 Imaging Agents

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Guideline Development Medicinal Products Treatment Smoking

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Guideline Evaluation Drugs Treatment Gastro Oesophageal Reflux Disease

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Guideline Clinical Investigation Medicinal Products Indicated Treatment Social Anxiety Disorder SAD

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Guideline Clinical Investigations Medicinal Products Treatment Pulmonary Arterial Hypertension

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Guideline Development Medicinal Products Treatment Post Traumatic Stress Disorder Ptsd

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Note Guidance Coordinating Investigator Signature Clinical Study Reports

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Guideline Evaluation Medicinal Products Treatment Chronic Constipation Including Opioid Induced Constipation AND Bowel Cleansing

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Guideline Pharmacokinetic AND Clinical Evaluation Modified Release Dosage Forms

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Appendix IV Guideline Investigation Bioequivalence Cpmpewpqwp140198 Rev1 Presentation Biopharmaceutical AND Bioanalytical Data Module 271

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Guideline Treatment Premenstrual Dysphoric Disorder Pmdd

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Appendix 4 Guideline Evaluation Anticancer Medicinal Products MAN

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Guideline Clinical Investigation Medicinal Products Treatment Lipid Disorders

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Guideline Clinical Investigation Medicinal Products Treatment Multiple Sclerosis

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Guideline Clinical Investigation Medicinal Products Treatment Systemic Lupus Erythematosus AND Lupus Nephritis

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Guideline Immunogenicity Assessment Biotechnology Derived Therapeutic Proteins

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Production AND Quality Control Medicinal Products Derived Recombinant DNA Technology

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Guideline Clinical Investigation Medicinal Products Prevention Venous Thromboembolism VTE Patients Undergoing High VTE Risk Surgery

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Guideline Clinical Investigation Medicinal Products Treatment Depression

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ICH Topic S 8 Immunotoxicity Studies Human Pharmaceuticals

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Guideline Medicinal Products Treatment Insomnia

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Guideline Clinical Development Medicinal Products Intended Treatment Chronic Primary Immune Thrombocytopenia

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Guideline USE Porcine Trypsin Used Manufacture Human Biological Medicinal Products

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Reflection Paper Clinical Aspects Related Tissue Engineered Products

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ICH Topic Q1C Stability Testing Requirements NEW Dosage Forms

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ICH Topic E 9 Statistical Principles Clinical Trials

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ICH Topic E 10 Choice Control Group Clinical Trials

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ICH Topic Q6B Specifications Test Procedures AND Acceptance Criteria Biotechnologicalbiological Products

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ICH Topic Q1F Stability Data Package Registration Applications Climatic Zones III AND IV

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ICH Topic Q1D Bracketing AND Matrixing Designs Stability Testing Drug Substances AND Drug Products

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ICH Guideline Q4B Annex 13 Note Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Bulk Density AND Tapped Density Powders General Chapter

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ICH Topic S 3 B Pharmacokinetics Repeated Dose Tissue Distribution Studies

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ICH Topic S 3 Toxicokinetics Guidance Assessing Systemic Exposure Toxicology Studies

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ICH Topic S 1 C R2 Dose Selection Carcinogenicity Studies Pharmaceuticals

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ICH Guideline Q4B Annex 10 Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Polyacrylamide GEL Electrophoresis General Chapter

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Pharmacokinetic Studies MAN

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ICH Topic Q 2 R1 Validation Analytical Procedures Text AND Methodology

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Clinical Investigation Medicinal Products Long Term USE

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Guideline Clinical Investigation Plasma Derived Fibrin Sealanthaemostatic Products

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ICH Guideline Q4B Annex 9 Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Tablet Friability General Chapter

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Guideline Process Validation Manufacture Biotechnology Derived Active Substances AND Data BE Provided Regulatory Submission

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Note Guidance Harmonisation Requirements Influenza Vaccines

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ICH Topic E 7 Studies Support Special Populations Geriatrics

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ICH Topic E 4 Dose Response Information Support Drug Registration

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ICH Topic E 2 Clinical Safety Data Management Definitions AND Standards Expedited Reporting

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ICH Topic E1 Population Exposure Extent Population Exposure Assess Clinical Safety

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ICH Topic Q6A Specifications Test Procedures AND Acceptance Criteria NEW Drug Substances AND NEW Drug Products Chemical Substances

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Guideline Clinical Evaluation Antifungal Agents Treatment AND Prophylaxis Invasive Fungal Disease

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Addendum Note Guidance Evaluation Medicinal Products Indicated Treatment Bacterial Infections Specifically Address Clinical Development NEW Agents Treat Disease DUE Mycobacterium

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Guideline Evaluation Pharmacokinetics Medicinal Products Patients Decreased Renal Function

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Guideline Good Pharmacovigilance Practices GVP Module V Risk Management Systems REV 2

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Guideline Good Pharmacovigilance Practices GVP Module VII Periodic Safety Update Report REV 1

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Note Guidance Start Shelf Life Finished Dosage Form Annex Note Guidance Manufacture Finished Dosage Form

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Annexes Cpmpich28395 Impurities Guideline Residual Solvents Cvmpvich50299 Guideline Impurities Residual Solvents

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Explanatory Note GVP Module VII

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Guideline Good Pharmacovigilance Practices GVP Module XVI Risk Minimisation Measures Selection Tools AND Effectiveness Indicators REV 2

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Questions AND Answers Additional Clarification Inclusion Criteria Guideline Clinical Investigation Medicinal Products Treatment Parkinsons Disease REV 2

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Guideline Good Pharmacovigilance Practices GVP Product OR Population Specific Considerations I Vaccines Prophylaxis Against Infectious Diseases

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Questions AND Answers Positions Specific Questions Addressed Pharmacokinetics Working Party

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Answers Chmp Scientific Advisory Group SAG Oncology Revision Anticancer Guideline

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Guideline Role Pharmacokinetics Development Medicinal Products Paediatric Population

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Guideline Similar Biological Medicinal Products Containing Biotechnology Derived Proteins Active Substance Quality Issues Revision 1

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Cell Culture Inactivated Influenza Vaccines Annex Note Guidance Harmonisation Requirements Influenza Vaccines Cpmpbwp21496

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Points Consider Reduction Elimination OR Substitution Thiomersal Vaccines

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Note Guidance Virus Validation Studies Design Contribution AND Interpretation Studies Validating Inactivation AND Removal Virus

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Guideline Quality Aspects Isolation Candidate Influenza Vaccine Viruses Cell Culture

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Guideline Quality Biological Active Substances Produced Transgene Expression Animals

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Position Statement USE Tumourigenic Cells Human Origin Production Biological AND Biotechnological Medicinal Products

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Guideline Clinical Investigation Human Plasma Derived VON Willebrand Factor Products

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Note Guidance Clinical Investigation Plasma Derived Antithrombin Products

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Guideline Clinical Investigation Human Anti D Immunoglobulin Intravenous Andor Intramuscular USE

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Guideline Clinical Investigation Recombinant AND Human Plasma Derived Factor Viii Products

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Guideline Clinical Investigation Recombinant AND Human Plasma Derived Factor IX Products

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Guideline Clinical Investigation Human Normal Immunoglobulin Subcutaneous Andor Intramuscular Administration Scigimig

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Guideline Clinical Investigation Hepatitis B Immunoglobulins

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Guideline Clinical Investigation Human Normal Immunoglobulin Intravenous Administration Ivig

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Biologicals Priority Applicant Determination Application Form

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3 Fucosyllactose

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Shea Butter Ethyl Esters

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Hemp Seed OIL

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Guideline Registry Based Studies

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Appendix 2 Guideline Evaluation Anticancer Medicinal Products MAN

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Guideline Process Validation Finished Products Information AND Data BE Provided Regulatory Submissions

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Guideline Stability Testing Stability Testing Existing Active Substances AND Related Finished Products

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ICH Topic Q 3 B R2 Impurities NEW Drug Products

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ICH Topic Q1B Photostability Testing NEW Active Substances AND Medicinal Products

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Note Guidance Manufacture Finished Dosage Form

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ICH Topic Q1E Evaluation Stability Data

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Considerations Inclusion Adolescent Patients Adult Oncology Clinical Trials Guidance Industry

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Guideline Radiopharmaceuticals

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Concept Paper Need Guideline USE Subgroup Analyses Randomised Controlled Trials

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Guideline Investigation Bioequivalence

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Quality Medicines QA

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Submitting Documents Using Real World Data AND Real World Evidence FDA Drugs AND Biological Products Guidance Industry

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Rare Diseases Natural History Studies Drug Development Guidance Industry

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Considerations USE Real World Data AND Real World Evidence Support Regulatory Decision Making Drug AND Biological Products Guidance Industry

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USE Electronic Health Record Data Clinical Investigations Guidance Industry

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Calanus Finmarchicus OIL

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Guideline Clinical Evaluation Medicinal Products Used Weight Management

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Guideline Exposure Medicinal Products During Pregnancy Need Post Authorisation Data

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Guideline Risk Assessment Medicinal Products Human Reproduction AND Lactation Data Labelling

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Guideline Clinical Investigation Medicinal Products Hormone Replacement Therapy Oestrogen Deficiency Symptoms Postmenopausal Women

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Guideline Clinical Development Fixed Combination Medicinal Products

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Annex Guideline Similar Biological Medicinal Products Containing Biotechnology Derived Proteins Active Substance NON Clinical AND Clinical Issues

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Guideline Similar Biological Medicinal Products Containing Biotechnology Derived Proteins Active Substance NON Clinical AND Clinical Issues

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Freedom Information Request Form

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Galactooligosaccharides

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Listed AND Assessed Listed Medicines Application AND Submission User Guide

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Guideline Clinical Investigation Medicinal Products Treatment Chronic Heart Failure

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Guideline Sterilisation Medicinal Product Active Substance Excipient AND Primary Container

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ICH S5 R3 Guideline Detection Reproductive AND Developmental Toxicity Human Pharmaceuticals

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Guideline NON Clinical AND Clinical Development Similar Biological Medicinal Products Containing LOW Molecular Weight Heparins

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Guideline NON Clinical AND Clinical Development Similar Biological Medicinal Products Containing Recombinant Erythropoietins

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Guideline Clinical Investigation Medicines Treatment Alzheimers Disease

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Guideline Clinical Development Medicinal Products Intended Treatment Pain

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Guideline Clinical Investigation Medicinal Products Treatment Axial Spondyloarthritis

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Reflection Paper Dissolution Specification Generic Solid Oral Immediate Release Products Systemic Action

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Adverse Drug Reaction Reporting Using Best Practice Installing ADR Reporting Template

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Adverse Drug Reaction Reporting Using Best Practice Using ADR Reporting Template

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Adverse Drug Reaction Reporting Using Medical Director Installing ADR Reporting Template

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Adverse Drug Reaction Reporting Using Medical Director Using ADR Reporting Template

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Refined Buglossoides Arvensis Seed OIL

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Chicken Sternum Cartilage Powder

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Organisation Common Technical Document Registration Pharmaceuticals Human USE M4

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Australian Manufacturing Licences AND Overseas GMP Certification

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Colchicine Tablet 05 MG AND 1 MG Product Specific Bioequivalence Guidance

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ICH Considerations General Principles Address Virus AND Vector Shedding

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Guideline Quality NON Clinical AND Clinical Aspects Gene Therapy Medicinal Products

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Guideline Setting Health Based Exposure Limits USE Risk Identification Manufacture Different Medicinal Products Shared Facilities

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Questions AND Answers Implementation Risk Based Prevention Cross Contamination Production

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Varying Your Medical Device OR IVD Artg Entry

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Publishing Over Counter OTC Medicine Product Information PI AND Consumer Medicine Information CMI

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Process Change Registered Over Counter OTC Medicine

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Biologicals Application Form Step Step Guide

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Completing Application Form Assessed Listed Medicine

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Information Applicants Completing PRE Submission Planning Form

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HOW Compile Literature Based Submissions

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Medical Device Incident Reporting Mdir Guide

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Post Market Review Compliance Dashboard

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OTC Dossier Documents Matrix

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Over Counter OTC Application Categorisation Framework

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Medicine Safety Issues Electronic Notification Form

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Application Import OR Export Therapeutic Good Mercury