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Nr.Title
2075Guideline on the Use of the CTD Format in the Preparation of a Registration Application for Traditional Medicinal Products
2076Bioequivalence Recommendations for Specific Products
2081Testing of Glycerin for Diethylene Glycol
2083Concept Paper on Revision of the Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for new Submissions and Variations
2084Procedure for the Preparation of Community Monographs for Traditional Herbal Medicinal Products
2085Procedure for the Preparation of Community Monographs for Herbal Medicinal Products with Well-Established Use
2086Procedure for Worksharing - Quality Variations
2096Guidance for Industry, FDA Staff, and October 4, 2004 FDA, regulated industry, and Division of Small Third Parties; Implementation of the third parties, Manufacturers, Inspection by Accredited Persons International and Program Under the Medical Device User Consumer Assistance, Fee and Modernization Act of 2002;Accreditation Criteria
2097Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices, June 1, 2004
2103Audit Language Requirements (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - Supplement 1)
2104MRA EG-Canada
2105Sectoral annex for pharmaceutical good manufacturing practices (GMP) Joint Sectoral Committee Meeting / EC - U. S. MUTUAL RECOGNITION AGREEMENT : Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs) - Joint Summary (21/05/99)
2106Council decision of of 8 October 2002 amending Decision 98/566/EC on the conclusion of an Agreement on mutual recognition between the European Community and Canada
2107Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia
2108Council decision of of 8 October 2002 amending Decision 98/508/EC on the conclusion of an Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia
2109Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
2110Council decision of of 8 October 2002 amending Decision 98/509/EC on the conclusion of an Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
2111Council decision of of 8 October 2002 amending Decision 2001/747/EC concerning the conclusion of the Agreement on Mutual Recognition between the European Community and Japan
2112Commission decision No 2/2002 of 8 January 2003 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment on the modification of the Annex 1 of the Agreement
2113Commission decision No 1/2003 of 28 January 2003 of the Committee established under the Agreement between the European Community and the Swiss Confederation on Mutual Recognition in relation to Conformity Assessment on the establishment of the list of conformity assessment bodies recognised under the Agreement
2114Corrigendum to Commission Decision 2002/615/EC of 22 July 2002 amending Decision 92/486/EEC establishing the form of cooperation between the ANIMO host centre and the Member States
2134Reflection paper on a proposed solution for dealing with minor deviations from the detail described in the Marketing Authorisation for Human and Veterinary Medicinal products (including biological products)
2137Guidelines on active pharmaceutical ingredient master file procedure
2176Q9 Quality Risk Management
2200Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
2222Bar Code Label Requirements - Questions and Answers
2224Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
2231Guidance Concerning the Braille Requirements for Labelling and the Package Leaflet
2232Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients
2233Environmental Risk Assessment of Medicinal Products for Human Use
2238Radiopharmaceutical products
2239Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals
2242WHO: Quality assurance of pharmaceuticals: a compendium of guidelines and related materials
2246Good trade and distribution practices for pharmaceutical starting materials
2247WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation
2248Certification scheme on the quality of pharmaceutical products moving in international commerce
2249Procedure for assessing the acceptability, in principle, of procurement agencies for use by United Nations agencies
2250Guidelines for the preparation of a procurement agency information file
2251Interim guidelines for the assessment of a procurement agency
2252Guide to good storage practices for pharmaceuticals
2253Quality assurance of pharmaceuticals: a compendium of guidelines and related materials
2254Quality system requirements for national GMP inspectorates
2255Pre-approval inspections
2256Inspection of pharmaceutical manufacturers
2257Inspection of drug distribution channels
2258Guidance on GMP: Inspection Report
2259Model Certificate of GMP
2260Basic tests for drugs : pharmaceutical substances, medicinal plant materials and dosage forms
2261The International Pharmacopoeia
2262Index of national, regional and international pharmacopoeias
2263Lists of available International Chemical Reference Substances and International Infrared Reference Spectra
2264Recommendations on Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products
2265The International Pharmacopoeia: revised concepts and future perspectives
2266Orally Disintegrating Tablets
2267Considerations for requesting analyses of drug samples
2268Model certificate of analysis
2269Good practices for pharmaceutical quality control laboratories
2270Prequalification of quality control laboratories. Procedure for assessing the acceptability of quality control laboratories for use by United Nations agencies
2271WHO Guidelines for preparing a laboratory information file
2272Quality control methods for medicinal plant materials
2273GAMP Good Practice Guide Electronic Data Archiving
2274Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
2275Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
2276Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
2277Guidelines on packaging for pharmaceutical products
2278Guidelines on import procedures for pharmaceutical products
2283Implementatin of risk management principles and activities within a QMS
2284Draft Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products
2285Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices
2286Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
2287Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
2289HUMAN FACTORS PRINCIPLES FOR MEDICAL DEVICE LABELING
2298Aide Memoire on GMP PARTICULARITIES IN THE MANUFACTURE OF MEDICINAL PRODUCTS TO BE USED IN CLINICAL TRIALS ON HUMAN SUBJECTS (PI 021-2) Sept 2007
2299Aide Memoire on INSPECTION OF BIOTECHNOLOGY MANUFACTURES (PI 024-2) Sept 2007
2300Aide Memoire on Inspection of Quality Control Laboratories(PI 023-2) Sept 2007
2301Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA
2302Premarket Notifications [510(k)]for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers
2303CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff
2314Figures to guideline ob GMPs for HVAC-Systems for non-sterile dosage forms
2329Q4B Annex 1(R1) Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC)
23332005/28/EC - Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
2334EC/2743/98 - Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products (Official Journal L 345, 19/12/1998 P. 3 - 8 CONSLEG - 95R0297 - 19/12/1998 - 15 p.).
2335EC/494/2003 - Commission Regulation (EC) No 494/2003 of 18 March 2003 amending Council Regulation (EC) No 297/95 on the fees payable to the European Agency for the Evaluation of Medicinal Products
2336EC/507/2006 - Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (Official Journal L 92, 30/3/2006 p. 6 - 9).
23372006/C 133/05 Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC (Official Journal C 133, 8/6/2006 p. 5 - 7)
2354EC/1905/2005 Council Regulation (EC) No 1905/2005, of 14 November 2005, amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency
2355EC/2049/2005 Commission Regulation (EC) No 2049/2005, of 15 December 2005, laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises
2370Annual Reports for Approved Premarket Approval Applications (PMA)
2507MEDICINAL PRODUCTS ACT (THE DRUG LAW) - (ARZNEIMITTELGESETZ – AMG)of the FEDERAL REPUBLIC OF GERMANY
2534AIDE-MEMOIRE ON THE INSPECTION OF MEDICINAL GASES PI 025-2
2547Guidance on Parametric Release (PIC/S PI 005-3)
2560Guide to Good Manufacturing Practices of preparation of medicinal products in healthcare establishments (PIC/S PE 010-3)
2562Site Master File
2565Water for pharmaceutical use (WHO Technical Series 970)
2566Heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (Annex5, TRS 961)
2567Validation
2568Good distribution practice for pharmaceutical products
2570Medical Device Use-Safety:Incorporating Human Factors Engineering into Risk Management
2571Multisource (generic) pharmaceutical products: guidelines on registration requirements
2572Propasal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate release, solid oral dosage forms
2573Additional Guidance for organisators performing in vivo bioequivalence studies
2574Guidelines for registration of fixed-dose combination medicinal products
2583COMPLIANCE POLICY GUIDE Sec. 160.900 Prescription Drug Marketing Act - Pedigree Requirements under 21 CFR Part 203
2585GAMP Good Practice Guide Global Information Systems
2586GAMP Good Practice Guide IT Infrastructure Control and Compliance
2587GAMP Good Practice Guide Testing of GxP Systems
2588GAMP Good Practice Guide Validation of Legacy Systems
2589GAMP Good Practice Guide A Risk-based Approach to Compliant Electronic Records and Signatures
2590GAMP Good Practice Guide Validation of Laboratory Computerized Systems
2598Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices
2599Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy
2600Principles of Medical Devices Classification
2601Principles of Conformity Assessment for Medical Devices
2602Information Document Concerning the Definition of the Term “Medical Device”
2603Medical Devices Post Market Surveillance: Content of Field Safety Notices
2604Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form
2605Review of Current Requirements on Postmarket Surveillance
2606Summary of Current Requirements for Where to Send Adverse Event Reports.
2619Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter
2621The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)
2635M2 eCTD Specification Questions and Answers and Change Requests
2637M4: Granularity Document - Annex to M4: Organization of the CTD
2638M4: The CTD - General Questions and Answers
2639M4Q: The CTD - Quality
2640M4: The CTD - Quality Questions and Answers/Location Issues
2641M4E: The CTD - Efficacy
2642M4: The CTD - Efficacy Questions and Answers
2643M4S: The CTD - Safety
2644M4S: The CTD - Safety Appendices
2645M4: The CTD - Safety Questions and Answers
2647Sterility Requirement for aqueous-Based Products for Oral Inhalation - small Entity Compliance Guide
2648Labeling OTC Human Drug Products
2659EC/1901/2006: Regulation (EC) No 1901/2006 ofor paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
2660EC/1902/2006: Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006amending Regulation 1901/2006 on medicinal products for paediatric use
2668Detailed guidance on the European clinical trials database (EUDRACT Database)
2669Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use
2671Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)
2673Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’
2676ANNEX 13 - Good Manufacturing Practice for the manufacture of investigational medicinal products
2677Detailed guidelines on good clinical practice specific to advanced therapy medicinal products
2678GUIDELINE ON THE REQUIREMENTS TO THE CHEMICAL AND PHARMACEUTICAL QUALITY DOCUMENTATION CONCERNING INVESTIGATIONAL MEDICINAL PRODUCTS IN CLINICAL TRIALS
2681Recommendation on the content of the trial master file and archiving
2682List of fields contained in the 'EudraCT' clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/C168/02
2683Guidance on Investigational Medicinal Products (IMPs) and 'non investigational medicinal products' (NIMPs) [
2685DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
2686COMMISSION DIRECTIVE 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
2687COMMISSION DIRECTIVE 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
2722Guide to Good Manufacturing Practice for Medicinal Products (PE 009-10) Part I
2723Guide to Good Manufacturing Practice for Medicinal Products (PE 009-10) Part II
2724Guide to Good Manufacturing Practice for Medicinal Products (PE 009-10) Annexe
2740Computerized Systems Used in Clinical Investigations
2748Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol
2749The international Pharmacopoeia - related substances tests: dosage form monographs guidance notes
2750General guidelines for the establishment, maintenance and distribution of chemical reference substances
2751Guidance on variations to a prequalified product dosser
2762Guidance for Industry: On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test
2764Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
2765Guidance for Industry: “Computer Crossmatch” (Electronic Based Testing for the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type)DRAFT GUIDANCE
2766Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components
2767Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments
2768Guidance for Industry: Bar Code Label Requirements, Questions and Answers
2769Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels
2770Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin G (IgG) Antibodies
2771Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products” DRAFT GUIDANCE
2772Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
2773Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency DRAFT GUIDANCE
2775Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
2776Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
2777Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
2778Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle DRAFT GUIDANCE
2779Guidance 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)
2780Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes DRAFT GUIDANCE
2781Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donations of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV
2782Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components
2783Guidance for Industry:Notifying FDA of Fatalities Related to Blood Collection or Transfusion
2784Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS
2785Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires
2786Guidance for Industry Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis DRAFT GUIDANCE
2787Guidance for Industry Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients
2789Guidance 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
2791Guidance for Industry Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax
2793Guidance for Industry Variances for Blood Collection from Individuals with Hereditary Hemochromatosis
2794Guidance for Industry Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture
2795Guidance for FDA Reviewers Premarket Notification Submissions for Blood and Plasma Warmers
2796Guidance for FDA Reviewers Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)
2797Guidance for FDA Reviewers Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components
2798Guidance for Industry Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
2800Guidance for Industry Monoclonal Antibodies Used as Reagents in Drug Manufacturing
2801Guidance for Industry Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods
2802Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion.
2803Guidance for Industry Use of Sterile Connecting Devices in Blood Bank Practices
2804Guidance for Industry Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens
2805Guidance for Industry Recommendations for Donor Questioning Regarding Possible Exposure to Malaria
2806Guidance for Industry In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2
2807Guidance 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
2808Guidance for Industry Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use
2809Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products DRAFT GUIDANCE
2810Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h “Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use”
2811Guidance for Industry Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product
2812Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma- Derived Biological Products, Animal Plasma or Serum-Derived Products