| Nr. | Title |
| |
| 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| 475 | Draft Guidance: Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval |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 |
| 495 | Guide to Inspections of Medical Device Manufacturers |
| 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 |
| 501 | Medical Device Reporting for Manufacturers |
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| 1272 | Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols |
| 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 |
| 1285 | Corrigendum (Official Journal L 235, 30/8/2006 p. 24 HU). |
| 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. |
| 1290 | Corrigendum (Official Journal L 230, 24/8/2006 p. 12 PL). |
| 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’ |
| 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 |
| 1330 | Comparison of the Device Adverse Reporting Systems in
USA, Europe, Canada, Australia & Japan |
| 1331 | Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices |
| 1332 | Charge & Mission Statement |
| 1333 | Adverse Event Reporting Guidance for the Medical
Device Manufacturer or its Authorized Representative |
| 1334 | Guidance On Quality Systems For The Design
And Manufacture Of Medical Devices |
| 1335 | Design Control Guidance For Medical Device Manufacturers |
| 1336 | Process Validation Guidance |
| 1337 | Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General Requirements - Supplement No. 4 - Compilation of Audit Documentation (Clause 5.7) |
| 1338 | Guidelines for Regulatory Auditing of Quality Systems
of Medical Device Manufacturers –Part 1: General Requirements |
| 1339 | Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements Supplement No. 6 Observed Audits of Conformity Assessment Bodies |
| 1340 | Audit Language Requirements |
| 1341 | Training Requirements for Auditors |
| 1343 | 21 CFR Part 314.420 Drug Master Files |
| 1344 | 21 CFR Part 26 Mutual recognition of pharmaceutical good manufacturing practice reports, and certain medical device product evaluation reports: US and the EC |
| 1345 | 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
| 1346 | 21 CFR Part 206 Imprinting of Solid Oral Dosage Form Drug Products for Human Use |
| 1356 | Providing Regulatory Submissions in Electronic Format--Receipt Date |
| 1360 | Reflection Paper on Markers Used for Quantitative and Qualitative Anaysis of Herbal Medicinal Products and Traditional Herbal Medicinal Products |
| 1381 | History of the Center for Drug Evaluation and Research |
| 1382 | About the Global Harmonization Task Force (GHTF) |
| 1386 | 2001/18/EC - Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC |
| 1387 | Current Practices in the Validation of Aseptic Processing - 2001 |
| 1388 | 2003/94/EC - Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use; Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products |
| 1389 | Introduction |
