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Nr.	Title
1942	APIC - Good manufacturing practices for Active ingredient manufacturers, with EFPIA, 1996
1943	APIC - Quality Management System for Active pharmaceutical Ingredient manufacturers - Integrating GMP into ISO 9001, December 1997
1944	APIC - Manufacture of sterile active pharmaceutical ingredients - guidance 1999
1945	APIC - Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants - Policy, 1999
1946	APIC - Good Manufacturing Practices in Active Pharmaceutical Ingredients Development, 1999
1947	APIC - Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants, guidance 2000
1948	APIC - GMPs for APIs: “How to do” Document - Interpretation of the ICH Q7a Guide - Version 6
1949	APIC - Computer validation Guide, December 2002
1950	APIC CEFIC Auditing Guide
1955	APIC - Parametric Release document, December 2002
1986	Botanical Drug Products
1988	Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER) APRIL 1996
1989	Development of new stereoisomeric drugs
1990	Drug Master Files for Bulk Antibiotic Drug Substances
1991	Drug Master Files, Current DMF Information
2002	Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (Issued 11/19/2004, Posted 11/19/2004)
2012	Corrigendum (Official Journal L 302, 20/11/2003 p. 40 DE).
2014	98/81/EC - Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (Official Journal L 330, 5/12/1998 p. 13 - 31).
2015	2004/27/EC Amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal L 136, 30/4/2004 p. 34 - 57).
2017	2003/94/EC - Commission Directive 2003/94/EC of 8 October 2003 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 (Official Journal L 262, 14/10/2003 p. 22 - 26).
2018	Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts
2021	COM/2003/839 Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted. [Update of the 1982 Commission Communication].
2022	Corrigendum (Official Journal L 75, 4/4/1995 p. 29.
2023	EC/726/2004 - Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
2032	Questions and Answers on Current Good Manufacturing (cGMP) for Drugs
2042	ANDAs: Pharmaceutical Solid Polymorphism
2047	Guidance for Industry Product Recalls, Including Removals and Corrections
2059	Annex 19: Reference and Retention Samples
2060	Q8(R2) Pharmaceutical Development
2070	APIC - Qualification of existing equipment (November 2004)
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, Version 3, August 2010
2075	Guideline on the Use of the CTD Format in the Preparation of a Registration Application for Traditional Medicinal Products
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
2097	Medical 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
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 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
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
2176	Q9 Quality Risk Management
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
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
2233	Environmental Risk Assessment of Medicinal Products for Human Use
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 pharmaceutical quality control laboratories
2270	Prequalification of quality control laboratories. Procedure for assessing the acceptability of quality control laboratories for use by United Nations agencies
2271	WHO Guidelines for preparing a laboratory information file
2272	Quality control methods for medicinal plant materials
2273	GAMP Good Practice Guide Electronic Data Archiving
2274	Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
2275	Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
2276	Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
2277	Guidelines on packaging for pharmaceutical products
2278	Guidelines on import procedures for pharmaceutical products
2283	Implementatin of risk management principles and activities within a QMS
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
2286	Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
2287	Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
2289	HUMAN FACTORS PRINCIPLES FOR MEDICAL DEVICE LABELING
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
2314	Figures to guideline ob GMPs for HVAC-Systems for non-sterile dosage forms
2329	Q4B Annex 1(R1) Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC)
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)
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
2370	Annual Reports for Approved Premarket Approval Applications (PMA)
2507	MEDICINAL PRODUCTS ACT (THE DRUG LAW) - (ARZNEIMITTELGESETZ – AMG)of the FEDERAL REPUBLIC OF GERMANY
2534	AIDE-MEMOIRE ON THE INSPECTION OF MEDICINAL GASES PI 025-2
2547	Guidance on Parametric Release (PIC/S PI 005-3)
2560	Guide to Good Manufacturing Practices of preparation of medicinal products in healthcare establishments (PIC/S PE 010-3)
2562	Site Master File
2565	Water for pharmaceutical use (WHO Technical Series 929)
2566	Heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (Annex5, TRS 961)
2567	Validation
2568	Good distribution practice for pharmaceutical products
2570	Medical Device Use-Safety:Incorporating Human Factors Engineering into Risk Management
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 Sec. 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.
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
2621	The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)
2635	M2 eCTD Specification Questions and Answers and Change Requests
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
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 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)
2673	Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’
2676	ANNEX 13 - Good Manufacturing Practice for the manufacture of investigational medicinal products
2677	Detailed guidelines on good clinical practice specific to advanced therapy medicinal products
2678	GUIDELINE ON THE REQUIREMENTS TO THE CHEMICAL AND PHARMACEUTICAL QUALITY DOCUMENTATION CONCERNING INVESTIGATIONAL MEDICINAL PRODUCTS IN CLINICAL TRIALS
2681	Recommendation on the content of the trial master file and archiving
2682	List 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
2683	Guidance on Investigational Medicinal Products (IMPs) and 'non investigational medicinal products' (NIMPs) [
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
2722	Guide to Good Manufacturing Practice for Medicinal Products (PE 009-9) Part I (Sept 2009)
2723	Guide to Good Manufacturing Practice for Medicinal Products (PE 009-9) Part II (Sept 2009)
2724	Guide to Good Manufacturing Practice for Medicinal Products (PE 009-9) Annexes (Sept 2009)
2740	Computerized Systems Used in Clinical Investigations
2748	Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol
2749	The international Pharmacopoeia - related substances tests: dosage form monographs guidance notes
2750	General guidelines for the establishment, maintenance and distribution of chemical reference substances
2751	Guidance on variations to a prequalified product dosser
2762	Guidance 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
2764	Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
2765	Guidance 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
2766	Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components
2767	Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments
2768	Guidance for Industry: Bar Code Label Requirements, Questions and Answers
2769	Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels
2770	Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin G (IgG) Antibodies
2771	Guidance 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
2772	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
2773	Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency DRAFT GUIDANCE
2775	Guidance 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 DRAFT GUIDANCE