Nr.	Titel
378	Guide to International Inspections and Travel - Table of Contents
379	Compliance References: Program Guidance Manual
380	Medical Device Reporting: An Overview
381	Compliance Program Guidance Manual 7348.808 Good Laboratory Practice (02/2001)
382	Compliance Program Guidance Manual 7356.002 Drug Manufacturing Insections (02/2002)
383	Compliance Program Guidance Manual 7382.845 Inspection of Medical Device Manufacturers (10/2000)
387	Guide to Inspections of Quality Systems (08/99)
388	Q 9: ICH Draft Consensus Guideline: Q9 Quality Risk Management
466	FDA Talk Paper Announcing the GMP Final Rule
467	DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS
468	"Do It By Design: An Introduction to Human Factors in Medical Devices"
469	Medical Device Quality Systems Manual: A Small Entity Compliance Guide
470	Human Factors Implications of the New GMP Rule Overall Requirements of the New Quality System Regulation
471	General Principles of Software Validation; Final Guidance for Industry and FDA Staff
473	Inspection of Medical Device Manufacturers; Final Guidance for Industry and FDA
475	Draft Guidance: Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval
479	2001/83/EC - Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use - English Version
481	Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation
482	2001/20/EC - Directive 2001/20/EC OF the European Parliament and of the Council of 4 April 2001 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 - English Version
483	Guide to Inspections of Foreign Medical Device Manufacturers
485	Guide to Bioresearch Monitoring Inspections of in vitro Diagnostic Devices
489	Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
490	Alternative to Certain Prescription Device Labeling Requirements
492	Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems
494	Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Final Guidance for Industry and FDA
496	Guide to Inspections of Infectious Disease Marker Testing Facilities
497	Third Party Review; An Instruction Manual For Conducting Reviews of Premarket Notifications
498	Premarket Approval Manual
500	HHS Publication FDA 96-4159 - Investigational Device Exemptions Manual
502	In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions
510	Environmental Assessment of Human Drug and Biologics Applications
511	Format and Content of the Chemistry, Manufacturing and Controls Section of an Application
518	SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
519	SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In-Vitro Release Testing and In Vivo Bioequivalence Documentation
521	Submission Documentation for Sterilisation Process Validation in Applications for Human and Veterinary Drug Products
522	Submission of Chemistry, Manufacturing and Controls Information for Synthetic Peptide Substances
523	Submitting Documentation for the Manufacture of and Controls for Drug Products
526	Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
528	SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum
529	Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Issued 7/1997, Posted 7/28/1997)
530	Container Closure Systems for Packaging Human Drugs and Biologics
531	Submitting Documentation for the Stability of Human Drugs and Biologics
538	Monoclonal Antibodies Used as Reagents in Drug Manufacturing (Issued 3/2001, Posted 3/28/2001)
545	Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products (Issued 5/1999, Posted 6/2/1999)
559	ANDA's: Impurities in Drug Substances
564	ANDAs: Impurities in Drug Products
566	Q1A(R2)Stability Testing of New Drug Substances and Products
567	Q1B Photostability Testing of New Drug Substances and Products
569	Q2A Text on Validation of Analytical Procedures
570	Q2B Validation of Analytical Procedures: Methodology
571	Q3A Impurities in New Drug Substances, Revision 1
572	Q3B(R) Impurities in New Drug Products
573	Q3C Impurities: Residual Solvents
574	Q3C Tables and List
575	Q3C Impurities: Residual Solvents Appendix 4
576	Q3C Impurities: Residual Solvents Appendix 5
577	Q3C Impurities: Residual Solvents Appendix 6
578	Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
579	Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
581	Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability
582	Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
583	Q6B Specifications: Test-Procedures and Acceptance Criteria for Biotechnological/Biological Products
584	Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
590	Providing Regulatory Submissions in Electronic Format - General Considerations
591	Q1A(R2) Stability Testing of new drugs and products (Revised guideline)
592	Example of an Electronic New Drug Application Submission
646	Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act
647	FDAMA Section 116 Implementation Information
649	EC-USA MRA, Sectoral Annex on Good Manufacturing Practices (GMP)
711	Compilation of Community Procedures on Inspections and Exchange of Information
712	Review of Pharmaceutical Legislation
753	Chapter 1 - Marketing Authorisation (updated version - November 2005)
754	Chapter 2 - Mutual Recognition (updated version - February 2007)
755	Chapter 3 - Community Referral (updated version - September 2007)
756	Chapter 4 - Centralised Procedure (updated version - April 2006)
757	Chapter 5 - Variations (updated version - February 2004)
758	Chapter 6 - Community Marketing Authorisation (updated version - November 2005)
759	Chapter 7 - General Information (updated version - July 2007)
778	Guideline on the categorisation of New Applications (NA) versus Variations Applications (V) (October 2003)
779	Guideline on the processing of renewals in the centralised procedure (October 2005)
780	Application form for renewal of a marketing authorisation and guidance for the completion of the application form (February 2007)
781	Guidance concerning consultation with target patient groups for the package leaflet
782	Guideline on fast track procedure for human influenza vaccines
783	Guideline on Summary of Product Characteristics (October 2005)
784	Guideline on Dossier requirements for Type IA and Type IB Notifications Revision 1 (July 2006)
785	Application form for variation to a marketing authorisation for medicinal products (human and veterinary) to be used in the mutual recognition and the centralised procedure (February 2007)
787	Guideline on the packaging information of medicinal products for human use authorised by the Community (July 2007)
788	Guideline on changing the classification for the supply of a medicinal product for human use
789	Guideline on the readability of the label and package leaflet of medicinal product for human use
793	Draft Annex 2: Manufacture of Biological Medicinal Products for Human Use
795	Q10 Pharmaceutical Quality System
832	91/412/EEC - Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products
835	Chapter 1: Quality Management (Revision 2008)
836	Chapter 2: Personnel
837	Chapter 3: Premises and Equipment
838	Chapter 4: Documentation
839	Chapter 5: Production
840	Chapter 6: Quality Control
841	Chapter 7: Contract Manufacture and Analysis
842	Chapter 8: Complaints and Product Recall
843	Chapter 9: Self Inspection
857	Annex 13: Manufacture of Investigational Medicinal Products
859	Annex 14: Manufacture of Medicinal Products derived from Human Blood or Plasma
864	Glossary
875	Q1B Stability Testing: Photostability Testing of New Drug Substances and Products
876	Q1C Stability Testing: Requirements for New Dosage Forms
879	Q2(R1) Validation of Analytical Procedures: Text and Methodology
885	Q5A (R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
886	Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
887	Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
888	Q5D Derivation and Characterisation of Cell Substrates Used For Production of Biotechnological/Biological Products
893	M4 Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
900	Verordnung zum Medizinproduktegesetz
902	Verordnung über die Verschreibungspflicht von Medizinprodukten
903	Verordnung über die Erfassung, Bewertung und Abwehr von Risiken bei Medizinprodukten (Medizinprodukte-Scherheitsplanverordnung )
918	Mutual Recognition Agreement Between the European Community and the United States of America Mai 1998
919	Joint Procedure for the Information Exchange of Serious or Life-Threatening Human / Animal Pharmaceutical Product Quality Defects and Recalls May 2001
926	Validation-Master Plan, IQ, OQ, non-sterile Process Validation, Cleaning Validation (PI 006-3) Sept 2007
929	PIC/S GMP Guide for Blood Establishments (PE 005-3) Sept 2007
931	Recommendations on Quality System Requirements for Pharmaceutical Inspectorates (PI 002-3)Sept 2007
932	Isolators used for Aseptic Processing and Sterility Testing (PI 014-3) Sept 2007
1100	Process Simulation Testing for Aseptically Filled Products
1101	Good Electronic Records Management (GERM)
1162	A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry
1167	GAMP-Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacturing, Version 4.0
1202	Aide-Memoire - Inspection of Utilities (PI 009-3) Sept 2007
1203	SOP - Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects (PI 010-3) Sept 2007
1204	Standard Operating Procedure - PIC/S Inspection Report Format (PI 013-3) Sept 2007
1217	Bundesgesetz vom 15. Dezember 2000 über Arzneimittel und Medizinprodukte (Heilmittelgesetz, HMG)
1218	Organisationsverordnung vom 28. September 2001 für das Schweizerische Heilmittelinstitut
1219	Verordnung vom 28. September 2001 über das Personal des Schweizerischen Heilmittelinstituts
1220	Verordnung vom 17. Oktober 2001 über die Bewilligungen im Arzneimittelbereich (Arzneimittel-Bewilligungsverordnung, AMBV)
1221	Verordnung vom 17. Oktober 2001 über die Arzneimittel (Arzneimittelverordnung, VAM)
1222	Verordnung vom 17. Oktober 2001 über die Arzneimittelwerbung (Arzneimittel-Werbeverordnung, AWV)
1224	Verordnung vom 17. Oktober 2001 über klinische Versuche mit Heilmitteln (VKlin)
1227	Verordnung vom 29. Mai 1996 über die Betäubungsmittel und die psychotropen Stoffe (Betäubungsmittelverordnung, BetmV)
1228	Verordnung vom 29. Mai 1996 über die Vorläuferchemikalien und andere Chemikalien, die zur Herstellung von Betäubungsmitteln und psychotropen Stoffen verwendet werden (Vorläuferverordnung, VorlV)
1235	Guidance for Industry - Cybersecurity for Networked Medical Devices Containing off-the-Shelf (OTS) Software
1238	Changes to an Approved NDA or ANDA, Questions and Answers
1241	EC-Swiss, Explanatory Notes to Chapter 15 (Medicinal Products GMP inspection and batch certification) of Annex 1 of the EU-Swiss MRA October 2002
1244	EC-Canada MRA, SECTORAL ANNEX ON GOOD MANUFACTURING PRACTICES (GMP)
1255	Verordnung des Schweizerischen Heilmittelinstituts vom 9. November 2001 über die Anforderungen an die Zulassung von Arzneimitteln (Arzneimittel-Zulassungsverordnung, AMZV) 26. November 2002
1257	Verordnung vom 22. Juni 2006 über die Gebühren des Schweizerischen Heilmittelinstituts (Heilmittel-Gebührenverordnung, HGebV)
1259	Verordnung vom 22. Juni des Schweizerischen Heilmittelinstituts über die vereinfachte Zulassung und die Meldepflicht von Arzneimitteln (VAZV)
1263	Reflection Paper: Chemical, pharmaceutical and biological information to be included in dossiers when Process Analytical Technology (PAT) is employed
1264	Q1E Evaluation of Stability Data
1265	Q1E Evaluation of Stability Data
1266	Q1D Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products
1267	Q3A(R2) Impurities in New Drug Substances
1268	Q3C(R3) Impurities: Guideline for residual solvents
1270	Q6A Attachments: Decision Trees #1 Through #8
1271	Verordnung über Vertriebswege für Medizinprodukte
1272	Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols
1273	Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - (AMG)
1274	Verordnung über die Anwendung der Guten Herstellungspraxis bei der Herstellung von Arzneimitteln und Wirkstoffen und über die Anwendung der Guten fachlichen Praxis bei der Herstellung von Produkten menschlicher Herkunft(Arzneimittel- und Wirkstoffherstellungsverordnung – AMWHV)
1275	Guide to Inspections of Quality Systems
1276	Medical Device Tracking
1277	Guideline for the Manufacture of In Vitro Diagnostic Products
1278	Guideline for the Monitoring of Clinical Investigations
1279	Quality System Information for Certain Premarket Application Reviews, Guidance for Industry
1280	PREMARKET NOTIFICATION 510(k): REGULATORY REQUIREMENTS FOR MEDICAL DEVICES
1281	Guidance For Industry - INSTRUCTIONS FOR COMPLETION OF MEDICAL DEVICE REGISTRATION AND LISTING FORMS FDA 2891, 2891a AND 2892
1282	Labelling - Regulatory Requirments for Medical Devices
1283	Medical Glove Guidance Manual
1284	GUIDANCE ON PARAMETRIC RELEASE (PI 005-2) July 2004
1286	89/105/EEC - Council Directive 89/105/EEC, of 21 December 1988, relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems - English Version
1287	EEC/2309/93 - Council Regulation (EEC) No 2309/93, of 22 July 1993, laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Amended by Commission Regulation (EC) No 649/98 of 23 March 1998 amending the Annex to Council Regulation (EEC) No 2309/93
1288	EC/297/95 - Council Regulation (EC) No 297/95, of 10 February 1995, on fees payable to the European Agency for the Evaluation of Medicinal Products. Amended by 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. Amendments
1289	EC/540/95 - Commission Regulation (EC) No 540/95, of 10 March 1995, laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93.
1291	Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials
1292	EC/1662/95 - Commission Regulation (EC) No 1662/95, of 7 July 1995, laying down certain detailed arrangements for implementing the Community decision-making procedures in respect of marketing authorizations for products for human or veterinary use.
1293	EC/2141/96 - Commission Regulation (EC) No 2141/96, of 7 November 1996, concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EEC) No 2309/93.
1294	EC/141/2000 - Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products.
1295	EC/847/2000 Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and‘clinical superiority’
1296	Anhang 16 zum EG-Leitfaden der Guten Herstellungspraxis: Zertifizierung durch eine Sachkundige Person und Chargenfreigabe
1297	Anhang 19 zum EG-Leitfaden der Guten Herstellungspraxis: Referenzproben und Rückstellmuster
1298	90/219/EEC - Council Directive 90/219/EEC, of 23 April 1990, on the contained use of genetically modified micro-organisms.
1301	EEC/1768/92 - Council Regulation No (EEC) 1768/92, of 18 June 1992, concerning the creation of a supplementary protection certificate for medicinal products.
1302	6/5/1982 Commission Communication on parallel imports of proprietary medicinal products for which marketing authorizations have already been granted.
1303	94/C 82/04 Commission Communication on the implementation of the new marketing authorization procedures for medicinal products for human and veterinary use in accordance with Council Regulation (EEC) No 2309/93 of 22 July 1993 and Council Directives 93/39/EEC, 93/40/EEC and 93/41/EEC, adopted on 14 June 1993.
1304	98/C 229/03 Commission communication on the Community marketing authorisation procedures for medicinal products
1305	75/320/EEC - Council Decision 75/320/EEC, of 20 May 1975, setting up a Pharmaceutical Committee.
1306	78/25/EEC - Council Directive 78/25/EEC, of 12 December 1977, on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products.
1312	COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS
1313	A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff
1314	Comparison Chart GMP/ISO 9000:1994
1315	Guidance on IDE Policies and Procedures
1316	Investigational Device Exemptions Manual
1317	Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers
1318	Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff (Update to K98-1)
1319	Guidance for Industry Product Development Protocol
1320	Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
1321	Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
1323	Essential Principles Of Safety & Performance of Medical Devices
1324	Labelling For Medical Devices
1325	Role of Standards in the Assessment of Medical Devices
1326	Q1C Stability Testing for New Dosage Forms
1327	Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
1328	Global Medical Device Competent Authority Report
1329	Minimum Data Set for Manufacturer Reports to Competent Authority