Nr.	Titel
2071	APIC - Technical Change Control Guideline 2004 (October 2004)
2072	Recommendation on the Need for Revision of (CHMP) >Note for Guidance on Investigation of Bioavailability and Bioequivalence> CPMP/EWP/QWP/1401/98
2073	The APIC Audit Programme, January 2008
2076	Bioequivalence Recommendations for Specific Products
2081	Testing of Glycerin for Diethylene Glycol
2083	Concept 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
2084	Procedure for the Preparation of Community Monographs for Traditional Herbal Medicinal Products
2085	Procedure for the Preparation of Community Monographs for Herbal Medicinal Products with Well-Established Use
2086	Procedure for Worksharing - Quality Variations
2096	Guidance 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
2098	Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria
2099	Medical Device Postmarket Vigilance and Surveillance: Proposal for Reporting of Use Errors with Medical Devices by their Manufacturer or Authorized Representative
2100	Medical Device Postmarket Vigilance and Surveillance: Universal Data Set for Manufacturer Adverse Event Reports
2101	Medical Device Postmarket Vigilance and Surveillance: Timing of Adverse Event Reports
2102	Manufacturer's Trend Reporting of Adverse Events
2103	Audit Language Requirements (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - Supplement 1)
2104	MRA EG-Canada
2105	Sectoral 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)
2106	Council 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
2107	Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia
2108	Council 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
2109	Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
2110	Council 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
2111	Council 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
2112	Commission 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
2113	Commission 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
2114	Corrigendum to Decision No 1/2003 (2003/128/EC) 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
2115	Update on current status of Mutual Recognition Agreements GMP sector
2134	Reflection 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)
2137	Guidelines on active pharmaceutical ingredient master file procedure
2166	Q 8 Pharmaceutical Development
2176	Q9 Quality Risk Management
2185	Arzneimittel-Zulassungsverordnung, AMZV 26. November 2002 Änderung vom 3. Juni 2002
2186	Arzneimittel-Zulassungsverordnung, AMZV 26. November 2002 Änderung vom 12. September 2002
2187	Arzneimittel-Zulassungsverordnung, AMZV 26. November 2002 Änderung vom 31. März 2005
2188	Heilmittel-Gebührenverordnung, HGebV vom 9. November 2001 Aenderung vom 12. September 2002
2200	Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
2222	Bar Code Label Requirements - Questions and Answers Posted: 6/7/2005, Publish Date: 6/7/2005
2224	Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
2231	Guidance Concerning the Braille Requirements for Labelling and the Package Leaflet
2232	Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients
2238	Radiopharmaceutical products
2239	Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals
2242	WHO: Quality assurance of pharmaceuticals: a compendium of guidelines and related materials
2246	Good trade and distribution practices for pharmaceutical starting materials
2247	WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation
2248	Certification scheme on the quality of pharmaceutical products moving in international commerce
2249	Procedure for assessing the acceptability, in principle, of procurement agencies for use by United Nations agencies
2250	Guidelines for the preparation of a procurement agency information file
2251	Interim guidelines for the assessment of a procurement agency
2252	Guide to good storage practices for pharmaceuticals
2253	Quality assurance of pharmaceuticals: a compendium of guidelines and related materials
2254	Quality system requirements for national GMP inspectorates
2255	Pre-approval inspections
2256	Inspection of pharmaceutical manufacturers
2257	Inspection of drug distribution channels
2258	Guidance on GMP: Inspection Report
2259	Model Certificate of GMP
2260	Basic tests for drugs : pharmaceutical substances, medicinal plant materials and dosage forms
2261	The International Pharmacopoeia
2262	Index of national, regional and international pharmacopoeias
2263	Lists of available International Chemical Reference Substances and International Infrared Reference Spectra
2264	Recommendations on Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products
2265	The International Pharmacopoeia: revised concepts and future perspectives
2266	Orally Disintegrating Tablets
2267	Considerations for requesting analyses of drug samples
2268	Model certificate of analysis
2269	Good practices for national pharmaceutical control laboratories
2270	Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
2271	Guidelines for preparing a laboratory information file
2272	Quality control methods for medicinal plant materials
2273	Update, Item 11.1 TRS 908
2274	Consultation of Stability studies in a global environment
2275	Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
2276	Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms
2277	Guidelines on packaging for pharmaceutical products
2278	Guidelines on import procedures for pharmaceutical products
2279	Anforderungen an elektronische Unterschriften
2280	Inspektionsverfahren bei genehmigungspflichtigen klinischen Prüfungen von Arzneimitteln
2281	Überprüfung der Qualifikation des Personals nach §§ 14, 52a, 63a, 72 Abs.2 und 74a AMG
2282	DIN EN ISO 17025 (Ausgabe 2005-08) Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien
2284	Draft Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products
2285	Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices
2287	Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
2289	HUMAN FACTORS PRINCIPLES FOR MEDICAL DEVICE LABELING (A)
2290	HUMAN FACTORS PRINCIPLES FOR MEDICAL DEVICE LABELING(B)
2291	Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
2298	Aide Memoire on GMP PARTICULARITIES IN THE MANUFACTURE OF MEDICINAL PRODUCTS TO BE USED IN CLINICAL TRIALS ON HUMAN SUBJECTS (PI 021-2) Sept 2007
2299	Aide Memoire on INSPECTION OF BIOTECHNOLOGY MANUFACTURES (PI 024-2) Sept 2007
2300	Aide Memoire on Inspection of Quality Control Laboratories(PI 023-2) Sept 2007
2301	Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA
2302	Premarket Notifications [510(k)]for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers
2303	CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff
2306	Guidance On Quality Systems For The Design And Manufacture Of Medical Devices
2313	SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES FOR HEATING, VENTILATION AND AIR-CONDITIONING (HVAC) SYSTEMS FOR NON-STERILE DOSAGE FORMS (October 2005)
2314	FIGURES TO SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES FOR HEATING, VENTILATION AND AIR-CONDITIONING (HVAC) SYSTEMS FOR NON-STERILE DOSAGE FORMS
2329	Q4B - Annex I Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC)
2330	Zweites Gesetz zur Anderung des Medizinproduktegesetzes (2. MPG-AndG).
2331	Gesetz zur Änderung medizinprodukterechtlicher und anderer Vorschriften
2333	2005/28/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
2334	EC/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.).
2335	EC/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
2336	EC/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).
2337	2006/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)
2348	Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC
2349	EC/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 (Official Journal L 340, 13/11/2005 p. 1 - 9)
2354	EC/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
2355	EC/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
2362	Verordnung zur Änderung medizinprodukterechtlicher Vorschriften
2363	Verordnung über das Errichten, Vertreiben und Anwenden von Medizinprodukten
2370	Annual Reports for Approved Premarket Approval Applications (PMA)
2507	MEDICINAL PRODUCTS ACT (THE DRUG LAW) - (ARZNEIMITTELGESETZ – AMG)of the FEDERAL REPUBLIC OF GERMANY
2509	Einleitung zum GMP-Leitfaden (Anlage 1 zur Bekanntmachung des BMG zu § 2 Nr. 3 der AMWHV)
2534	AIDE-MEMOIRE ON THE INSPECTION OF MEDICINAL GASES PI 025-2
2547	Guidance on Parametric Release (PIC/S PI 005-3)
2556	Leitfaden der Guten Herstellungspraxis, Teil I: Anlage 2 zur Bekanntmachung des Bundesministeriums für Gesundheit zu § 2 Nr. 3 der Arzneimittel- und Wirkstoffherstellungsverordnung vom 27. Oktober 2006
2557	Leitfaden der Guten Herstellungspraxis, Teil II: Anlage 3 zur Bekanntmachung des Bundesministeriums für Gesundheit zu § 2 Nr. 3 der Arzneimittel- und Wirkstoffherstellungsverordnung vom 27. Oktober 2006
2560	Guide to Good Manufacturing Practices of preparation of medicinal products in healthcare establishments (PIC/S PE 010-3)
2561	Verordnung vom 18. Mai 2005 über die gute Laborpraxis (GLPV)
2562	Arzneimittel-Zulassungsverordnung, AMZV 26. November 2002 Änderung vom 22. Juni 2006
2563	Verordnung vom 22. Juni 2006 des Schweizerischen Heilmittelinstituts über die Zulassung von Komplementär- und Phytoarzneimitteln (KPAV)
2564	Verordnung vom 22. Juni 2006 betreffend die Liste der verschreibungspflichtigen Medizinprodukte (VLvM)
2565	Water for pharmaceutical use
2566	Heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
2567	WHO Supplementary Guideline on Good Manufacturing Practices: Validation
2568	Good distribution practice for pharmaceutical products
2569	Anhang 1 zum EG-Leitfaden der Guten Herstellungspraxis: Herstellung steriler Arzneimittel
2570	Update, Item 10.1. TRS 937, 2006
2571	Multisource (generic) pharmaceutical products: guidelines on registration requirements
2572	Propasal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate release, solid oral dosage forms
2573	Additional Guidance for organisators performing in vivo bioequivalence studies
2574	Guidelines for registration of fixed-dose combination medicinal products
2583	COMPLIANCE POLICY GUIDE 160.900 Prescription Drug Marketing Act - Pedigree Requirements under 21 CFR Part 203
2585	GAMP Good Practice Guide Global Information Systems
2586	GAMP Good Practice Guide IT Infrastructure Control and Compliance
2587	GAMP Good Practice Guide Testing of GxP Systems
2588	GAMP Good Practice Guide Validation of Legacy Systems
2589	GAMP Good Practice Guide A Risk-based Approach to Compliant Electronic Records and Signatures
2590	GAMP Good Practice Guide Validation of Laboratory Computerized Systems
2598	Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices
2599	Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy
2600	Principles of Medical Devices Classification
2601	Principles of Conformity Assessment for Medical Devices
2602	Information Document Concerning the Definition of the Term “Medical Device”
2603	Medical Devices Post Market Surveillance: Content of Field Safety Notices
2604	Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form
2605	Review of Current Requirements on Postmarket Surveillance
2606	Summary of Current Requirements for Where to Send Adverse Event Reports.
2607	Verordnung über die Erfassung, Bewertung und Abwehr von Risiken bei Medizinprodukten
2608	GENERAL REQUIREMENTS FOR THE PRODUCTION AND CONTROL OF LIVE MAMMALIAN BACTERIAL AND VIRAL VACCINES FOR VETERINARY USE
2609	GENERAL REQUIREMENTS FOR THE PRODUCTION AND CONTROL OF INACTIVATED MAMMALIAN BACTERIAL AND VIRAL VACCINES FOR VETERINARY USE
2610	SPECIFIC REQUIREMENTS FOR THE PRODUCTION AND CONTROL OF AVIAN LIVE AND INACTIVATED VIRAL AND BACTERIAL VACCINES
2612	SPECIFIC REQUIREMENTS FOR THE PRODUCTION AND CONTROL OF PIG LIVE AND INACTIVATED VIRAL AND BACTERIAL VACCINES
2613	SPECIFIC REQUIREMENTS FOR THE PRODUCTION AND CONTROL OF OVINE AND CAPRINE LIVE AND INACTIVATED VIRAL AND BACTERIAL VACCINES
2614	SPECIFIC REQUIREMENTS FOR THE PRODUCTION AND CONTROL OF EQUINE LIVE AND INACTIVATED VIRAL AND BACTERIAL VACCINES
2615	MANUFACTURE OF THE FINISHED DOSAGE FORM
2616	LIST OF QUALITY GUIDELINES ACCEPTED FROM THE GUIDELINES FOR HUMAN USE
2618	Current Good Manufacturing Practice; Amendment of Certain Requirements For Finished Pharmaceuticals Withdrawal
2619	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter
2620	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter
2621	The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)
2635	M2 eCTD Specification Questions and Answers adn Change Requests
2636	M3 Nonclinical Safety Studies for the Conduct of Human Clinical trials for Phramaceuticals
2637	M4: Granularity Document - Annex to M4: Organization of the CTD
2638	M4: The CTD - General Questions and Answers
2639	M4Q: The CTD - Quality
2640	M4: The CTD - Quality Questions and Answers/Location Issues
2641	M4E: The CTD - Efficacy
2642	M4: The CTD - Efficacy Questions and Answers
2643	M4S: The CTD - Safety
2644	M4S: The CTD - Safety Appendices
2645	M4: The CTD - Safety Questions and Answers
2647	Sterility Requirement for aqueous-Based Products for Oral Inhalation - small Entity Compliance Guide
2648	Labeling OTC Human Drug Products
2659	EC/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
2660	EC/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
2667	Table of Contents - Foreword - General Information
2668	Detailed guidance on the European clinical trials database (EUDRACT Database)
2669	Detailed 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
2671	Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial
2673	Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use
2674	Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance – Clinical Trial Module)
2676	ANNEX 13 - Manufacture of investigational medicinal products
2677	COMPILATION OF COMMUNITY PROCEDURES ON INSPECTIONS AND EXCHANGE OF INFORMATION: COMMUNITY BASIC FORMAT FOR MANUFACTURER’S AUTHORISATION
2678	GUIDELINE ON THE REQUIREMENTS TO THE CHEMICAL AND PHARMACEUTICAL QUALITY DOCUMENTATION CONCERNING INVESTIGATIONAL MEDICINAL PRODUCTS IN CLINICAL TRIALS
2679	Chapter 4: Recommendation on Inspections
2681	RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING
2682	VOLUME 10 - NOTICE TO APPLICANTS: Questions & Answers - Clinical Trial Documents
2683	Good Clinical Practice
2685	DIRECTIVE 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
2686	COMMISSION 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
2687	COMMISSION 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
2709	Liste homöopatischer und antrophosophischer Stoffe
2710	DIRECTIVE 2008/29/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission
2711	Liste der Schüsslersalze
2712	Liste der dokumentierten traditionellen asiatischen Stoffe
2713	Liste TAS
2714	The joint IPEC-PQG Good Manufacturing Practices guide for Pharmaceutical Excipients
2715	IPEC Good Distribution Practices Guide for Pharmaceutical Excipients
2716	IPEC Good Manufacturing Practices Audit Guideline for Bulk Pharmaceutical Excipients