Nr.	Titel
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
1396	Applications for Parenteral Products in Plastic Immediate Containers
1408	ISO 11462-1 Guidelines for implementation of statistical process control (SPC)- Part 1 Elements of SPC
1409	DIN ISO 2859-1 Annahmestichprobenprüfung anhand der Anzahl fehlerhafter Einheiten oder Fehler (Attributprüfung) - Teil 1: Nach der annehmbaren Qualitätsgrenzlage (AQL) geordnete Stichprobenpläne für die Prüfung einer Serie von Losen
1410	DIN ISO 2859-2 Annahmestichprobenprüfung anhand der Anzahl fehlerhafter Einheiten oder Fehler (Attributprüfung); Nach der zurückzuweisenden Qualitätsgrenzlage (LQ) geordnete Stichprobenanweisungen für die Prüfung einzelner Lose anhand der Anzahl fehlerhafter Einheiten
1411	DIN ISO 2859-3 Annahmestichprobenprüfung anhand der Anzahl fehlerhafter Einheiten oder Fehler (Attributprüfung); Skip-lot-Verfahren
1412	ISO DIS 3951-1 Sampling procedures for inspection by variables - Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single A
1437	PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance
1438	Good Practices for Computerised Systems in Regulated "GXP" Environments (PI 011-3) Sept 2007
1441	Part 11, Electronic Records, Electronic Signatures: Scope and Application
1449	GAMP Good Practice Guide Validation of Process Controls Systems
1450	Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
1451	Drug Approval Application Process
1455	Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV (Revision 1)
1462	Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
1463	Guide to Good Manufacturing Practice for Medicinal Products (PE 009-7) Introduction (Sept 2007)
1464	PIC/S Guide to Inspections of Source Plasma Establishment and Plasma Warehouses (PI 008-3) Sept 2007
1465	Site Master File for Source Plasma Establishments (PI 019-3) Sept 2007
1466	Site Master File for Plasma Warehouses (PI 020-3) Sept 2007
1470	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
1472	Verordnung über die Anwendung der Guten Klinischen Praxis bei der Durchführung von Klinischen Prüfungen mit Humanarzneimitteln
1475	Accetability of Standards from Alternative Compendia (BP/EP/JP)
1476	Blood Establishment Computer Systems Validation in the User's Facility
1477	EC/1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Note: shall apply from 30 December 2008)(Official Journal L 324, 10/12/2007 p. 121 - 137).
1478	EC/658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (Official Journal L 155, 15/6/2007 p. 10 - 19).
1502	The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP)
1503	GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS
1504	Section 1
1505	Section 2
1506	Section 3
1507	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
1508	INDs for Phase 2 and Phase 3 Studies; Chemistry, Manufacturing, and Controls Information
1513	Eudralex Volume 10 - Clinical Trials
1519	Part 11, Electronic Records, Electronic Signatures - Scope and Application
1521	Providing Regulatory Submissions in Electronic Format - General Considerations
1522	Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions using the eCTD Specifications
1523	Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Saftey Reports
1524	Providing Regulatory Submissions in Electronic Format - Postmarketing Periodic Adverse Drug Experience Reports
1525	Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling
1529	Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products
1530	CPMP/QWP/2054/03 Annex II to Note for Guidance on Process Validation CHMP/QWP/848/99 and EMEA CVMP/598/99 Non-Standard Processes (Adopted by CHMP July 2004)
1533	Position Paper on Specifications for Class 1 and Class 2 Residual Solvents in Active Substances
1534	Note for Guidance on Specification Limits for Residues of Metal Catalysts
1535	Note for Guidance on Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products
1536	Note for Guidance on Parametric Release
1537	Note for Guidance on Quality of Modified Release Products: A. Oral Dosage Forms; B. and Transdermal Dosage Forms; Section I (Quality)
1568	Explanatory Note ot the Operation of Two-Year Transition Period for Application of Note for Guidance on Residual Solvents to Marketed Products
1570	Note for Guidance on Manufacture of the Finished Dosage Form
1576	WHO: Good Manufacturing Practices for Pharmaceutical Products: Main Principle
1577	Active pharmaceutical ingredients (bulk drug substances)
1578	Pharmaceutical excipients
1579	Sterile pharmaceutical products
1580	Biological products
1581	Investigational pharmaceutical products for clinical trials in humans
1582	Herbal medicinal products
1596	DIRECTIVE 2004/28/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products
1597	Guideline on Plastic Immediate Packaging Materials
1624	Produktionsprozesse in der Pharmazie
1627	Inspektion von Qualifizierung und Validierung in pharmazeutischer Herstellung und Qualitätskontrolle
1629	Erstellen eines risiko- und zeitabhängigen Inspektionsplanes
1630	Vorbereitung, Durchführung und Nachbereitung von Inspektionen im Bereich GMP
1631	Organisatorische Aspekte der Vorbereitung, Durchführung und Nachbereitung von GMP-Drittlandinspektionen
1632	Teambildung / Beteiligung von Sachverständigen
1633	Site Master File (SMF)
1634	Erstellung und Format von Inspektionsberichten
1635	Amtliche Entnahme von Proben nach § 65 AMG
1636	Vorgehensweise bei Arzneimittelrisiken, Verbraucherbeschwerden und sonstigen Beanstandungen
1637	Bewertung von Abweichungen, Fehlern und Mängeln
1638	Maßnahmen aufgrund von Fehlern und Mängeln
1639	Entscheidung über die Erteilung einer Herstellungserlaubnis gemäß § 13 AMG oder Einfuhrerlaubnis gemäß § 72 Absatz 1 AMG
1641	Ausstellung von Zertifikaten gemäß § 73a Abs. 2 AMG (WHO-Zertifikate)
1642	Information der Länder durch die ZLG-Website
1643	Austausch von Zertifikaten im Rahmen von Drittstaatenabkommen (MRA)
1644	Amtliche Untersuchung von Proben
1645	Umgang mit Ergebnissen: Bewertung und Bericht sowie Ergebnisse außerhalb der Spezifikation [OOS-(Out-of-Specification) Results]
1647	Guideline on Control of Impurities of Pharmacopoeial Substances: Compliance with the European Pharmacopoeial General Monograph "Substances for Pharmaceutical Use" and General Chapter" Control of Impurities in Substances for Pharmaceutical Use"
1650	Q1E Evaluation of Stability Data
1837	DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use
1838	2002/98/EC - Directive 2002/98/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
1839	2003/63/EC - COMMISSION DIRECTIVE 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
1849	Guideline on Vaccine Antigen Master File/ Plasma Master File (VAMF/PMF) (August 2004)
1850	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)
1851	Guideline on the procedure for VAMF certification
1852	Guideline on the procedure for PMF certification
1862	NOTICE TO APPLICANTS Volume 6B VETERINARY MEDICINAL PRODUCTS Presentation and content of the dossier
1865	Bioanalytical Method Validation (Issued 5/2991, Posted 5/22/2001)
1866	Comparability Protocols - Protein Drug Products and Biological Products . Chemistry, Manufacturing, and Controls Information
1867	Bioavailability and Bioequivalence Studies for orally administered drug products - General considerations (Issued 3/2003, Posted 3/19/2003)
1868	Colestryramine Powder in Vitro Bioequivalence (Interim Guidance)
1869	Clozapine Tablets in Vivo Bioequivalence and in Vitro Dissolution Testing (Issued 06/17/2005, Reposted 06/17/2005)
1870	Corticosteroids, Dermatologic (topical) In Vivo (Issued 6/2/1995, Posted 3/6/1998)
1871	Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Issued 8/1997, Posed 8/25/1997)
1872	Extended Release Oral Dosage Forms: Development, Evaluation and Application of In Vitro/In Vivo Correlation (Issued 9/1997, Posted 9/26/1997)
1873	Common Technical Document - Quality Questions and Answers/Location Issues
1874	CTD General Questions and Answers
1875	M4: Organization of the CTD
1876	M4: The CTD — General Questions and Answers
1877	M4: The CTD — Quality Questions and Answers/Location Issues
1884	Food-Effect Bioavailability and Fed Bioequivalence Studies (Issued 12/2002, Posted 1/30/2003)
1885	Metaproterenol Sulfate and Albuterol Metered Dose Inhalers in Vitro (Issued 6/27/1989, Posted 3/2/1998)
1887	Potassium Chloride (slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing (Revised 6/6/1994, Posted 6/22/1998)
1888	Statistical Approaches to Establishing Bioequivalence (Issued 2/2001; Posted 2/1/2001)
1889	Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (Issued 8/2000, Poste 8/31/2000)
1890	Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Posted 4/2/2003)
1892	Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide
1893	Conjugated Estrogens, USP-ÖC-MS-Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence (Issued 3/6/2000, Posted 3/6/2000)
1894	M4E: The CTD — Efficacy
1896	M4: The CTD — Efficacy Questions and Answers
1897	Bioequivalence Studies Data and Detailed Statistical Methodology (Posted 3/2/1998)
1898	M4S: The CTD — Safety
1900	Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing (Issued 8/2002, Posted 8/6/2002)
1902	Analytical Procedures and Methods Validation (Issued 8/2000, Posted 8/30(2000)
1903	Comparability Protocols - Chemistry, Manufacturing, and Controls Information (Issued 2/2003, Posted 2/20/2003)
1904	Drugs, Biologics, and Medical Devices Derived from Bioengineering Plants for Use in Humans and Animals (Posted 9/11/2003)
1905	Drug Product: Chemistry, Manufacturing, and Controls Information (Issued 1/2003, Poted 1/28/2003)
1906	Drug Substance: Chemistry, Manufacturing, and Controls Information (Issued 1/2003, Posted 1/28/2003)
1907	Interpreting Sameness of Monoclonal Antibody Products under the Orphan Drug Regulations (Issued 1/2004, Posted 1/6/2004)
1908	Liposome Drug Products: Chemistry, Manufacturing, and Controls: Human Pharmacokinetics, Bioavailability, and Labeling Documentation (Issued 7/2002, Posted 8/20/2002)
1935	Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
1941	APIC - List of Abbreviations & Acronyms
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 5: Final
1949	APIC - Computer validation Guide, December 2002
1950	APIC - Auditing Guide, September 2008
1951	Auditing Guide Appendix A – Secrecy Agreement
1952	Auditing Guide Appendix B – Pre-Audit Questionnaire
1953	Auditing Guide Appendix C – Aide Mémoire
1954	Auditing Guide Appendix D – Audit Report Template
1955	APIC - Parametric Release document, December 2002
1970	CPMP/QWP/450/03 corr Annexes to Specifications for class 1 and class 2 residual solvents in active substances (Adoped by CHMP July 2004)
1971	CHMP/QWP/297/97 Rev. 1 corr Guideline on Summary of Requirements for Active Substances in the Quality Part of the Dossier
1972	CPMP/QWP/1529/04 CPMP Guideline on Control of Impurities of Pharmacopoeial Substances (Adopted for implementation, April 2004)
1973	CPMP/QWP/227/02 Rev 1 (EMEA/CVMP/134/02 Rev 1) Guideline on Active Substance Master File Procedure (February 2004)
1975	CPMP/QWP/609/96 Rev. 1 Note for guidance on Declaration of Storage Conditions for Medicinal Products Particulars and Active Substances (Annex to note for Guidance on Stability Testing of New Active Substances and Medicinal Products, Annex to Note for Guidance on Stability of Existing Active Substances and Related Finished Products) (Date of coming into operation October 2003). Rev 2 withdrawn.
1976	CPMP/QWP/130/96 Rev. 1 Note for guidance on Chemistry of the New Active Substance. (CPMP adopted December 2003)
1977	CPMP/QWP/122/02 Rev.1 Note for guidance on Stability Testing of Existing Active Substances and Related Finished products (Adoption by CPMP December 2003)
1978	CPMP/QWP/3309/01 (EMEA/CVMP/961/01) Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data to be forwarded in the Part II of the Dossier for a Marketing Authorisation (Adopted by CPMP/CVMP February 2003)
1979	CPMP/QWP/158/01 Revision (CVMP/115/01) Note For Guidance on Quality of Water for Pharmaceutical Use (Revision adopted by CPMP/CVMP May 02)
1980	CPMP/QWP/848/96 (EMEA/CVMP/598/99) Note for Guidance on Process Validation (CPMP/CVMP Adopted Feb. 01)
1981	CPMP/QWP/8567/99 Explanatory Note on the Operation of Two-Year Transition Period for Application of Note for Guidance on Residual Solvents to Marketed Products
1982	CPMP/QWP/576/96 Note for Guidance on Stability testing for a type II variation to a Marketing Authorisation (CPMP adopted April. 98)
1983	CPMP/QWP/576/96 - Rev 1 Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation
1985	CPMP/SWP/QWP/4446/00 Note for Guidance on Specification Limits for Residues of Metal Catalysts, (Re-released for consultation June 2002) Corrigendum
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)
2011	Consolidated 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 as amended by Directive 2002/98/EC, Directive 2004/24/EC and Directive 2004/27/EC.
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 - Directive 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
2019	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.).
2020	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
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 to Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (Official Journal of the European Communities No L 35 of 15 February 1995)
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 (Official Journal L 136, 30/4/2004 p. 1 - 33).
2028	Gesetz über die Werbung auf dem Gebiet des Heilwesens
2029	Verordnung über die Änderung der Klassifizierung von Brustimplantaten
2032	Questions and Answers on Current Good Manufacturing (cGMP) for Drugs
2039	Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
2042	ANDAs: Pharmaceutical Solid Polymorphism
2047	Guidance for Industry Product Recalls, Including Removals and Corrections
2050	Verordnung über die Tierarzneimittel (Tierarzneimittelverordnung, TAMV) vom 18. August 2004 (Stand am 7. September 2004)
2051	Überwachung von Stoffen, die als Tierarzneimittel verwendet werden können (gemäß § 69a AMG)
2052	Aide Mémoire Bio- und Gentechnologie
2059	Annex 19: Reference and Retention Samples
2060	Q8 Pharmaceutical Development
2070	APIC - Qualification of existing equipment (November 2004)