Here a list of key regulatory guidelines which need to be considered in planning and implementing drug development:

• MHRA Best Practices In Reporting Of Individual Case Safety Reports (ICSRs), Feb 2011
• EU Regulation No. 1235/2010 of the European Parliament and of the Council: Amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and Regulation (EC) No 1394/2007 on advanced therapy and medicinal products, Dec 2010
• Draft Guidance for Industry and Investigators; Safety Reporting Requirements for INDs and BA/BE Studies, Sep 2010
• Draft detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use (CT-3), Public Consultation Document, Jul 2010
• Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting to IRBs- Improving Human Subject Protection, Jan 2009
• Draft EMA/712397/2009 European Medicines Agency, Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorization applications to the EMA
• EMEA/INS/577144/2009 Mandate, Objectives and Rules of Procedure for the Pharmacovigilance Inspectors Working Group, Nov 2009
• EMEA/INS/274494/2008 Pharmacovigilance Inspection Policy for Centralized Procedures-Medicinal Products for Human Use, Nov 2009
• European Commission, A Guideline on Summary of Product Characteristics (SmPC), rev 2, Sep 2009
• EMEA/CHMP/PhVWP/503449/2007 Guideline on the Conduct of Pharmacovigilance for Vaccines for pre- and post-exposure Prophylaxis against Infectious Diseases, Jul 2009
• Pharmaceutical package. Safe, innovative and accessible medicines: a renewed vision for the pharmaceutical sector. COM (2008) 666 final
• Good Pharmacovigilance Practice Guide (MHRA Purple Guide), Nov 2008
• Eudralex Volume 9A: EU Pharmacovigilance rules for Medicinal Products for Human and Veterinary Use, Notice to Marketing Authorization Holders, Sep 2008
• Distribution Requirements and Address Lists for Periodic Safety Update Reports (PSURs), EMEA/129976/08 rev. 6
• Procedure for Conducting Pharmacovigilance Inspections requested by the CHMP, EMEA/INS/GCP/218148/2007
• Council Regulation (EC) No. 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and Commission Staff Working Documents as of Dec 10, 2008. COM (2008) 664 final
• Regulation (EC) N° 1901/2006 of the European Parliament and the Council of 12December 2006 on medicinal product for pediatric use and amending Regulation (EEC) N° 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) N° 726/2004
• Regulation (EC) N° 1902/2006 of the European Parliament and the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for pediatric use
• Template for EU Risk Management Plan (EU-RMP), EMEA/192632/2006, Sep 2006
• CHMP Guideline on Risk Management Systems for Medicinal Products for Human Use (EMEA/CHMP/96268/2005), integrated in Volume 9A
• Heads of Agencies Report, Establishing a European Risk Management Strategy, Jan 2003
• Guideline on Data Monitoring Committees, CHMP/EWP/5872/03, Jan 2006
• Directive 2001/83/EC as amended by Council Directive 2004/27/EC, Directive 2004/24/EC and Commission Directive 2003/63/EC and Commission Staff Working Documents as of Dec 10, 2008
• Commission Regulation (EC) No. 540/95
• CPMP/PhVWP/1618/01: “Position Paper on Compliance with Pharmacovigilance Regulatory Obligations”, adopted Dec 2001
• Council Directive 2001/20/EC and Commission Directive 2005/28/EC
• CPMP/ICH/135/95 Guideline for Good Clinical Practice, Jan 1997 (ICH E6 R1)
• Eudralex Volume 10, Chapter II: “Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use”, Apr 2006
• Eudralex Volume 10, Chapter II: “Detailed guidance on the European database of suspected unexpected serious adverse reactions (EudraVigilance – Clinical Trial Module)”
• CPMP/ICH/377/95: (E2A) “Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting”
• CPMP/ICH/287/95, plus modification: (E2B) “Note for Guidance on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports” and ICH E2B/M2 “Note for Guidance on Electronic Transmission of Individual Case Safety Reports Message Specification”
• CPMP/ICH/288/95: (E2C) “Note for Guidance on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs” plus E2CA (Addendum)
• CPMP/ICH/3945/03: (E2D) “Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting”
• CPMP/ICH/5716/03: (E2E) “Pharmacovigilance Planning”, adopted Nov 2004
• ICH E2F Development Safety Update Report, CHMP/ICH/309348/08
• CIOMS I: International Reporting of Adverse Drug Reactions, 1990
• CIOMS II: International Reporting of Periodic Drug-Safety, 1992
• CIOMS III/V: Guidelines for Preparing Core Clinical-Safety Information on Drugs, 2^nd edition 1999
• CIOMS IV: Benefit-Risk Balance for Marketed Drugs. Evaluating Safety Signals, 1998
• CIOMS V: Current Challenges in Pharmacovigilance: Pragmatic Approaches, 2001
• CIOMS VI: Managing Safety Information from Clinical Trials, 2005
• CIOMS VII: The Development Safety Update Report (DSUR): Harmonizing the Format and Content for Periodic Reporting During Clinical Trials, 2006
• CIOMS VIII: Practical Aspects of Signal Detection in Pharmacovigilance, 2010
• PIC/S Good Practices for Computerized Systems in Regulated “GxP” environment (PI 011-2)
• The legal basis for pharmacovigilance inspections at a national level is laid down in Chapter V, Article 26 of 75/319/EEC
• Guideline on Safety and Efficacy Follow-up Risk- Management of Advanced Therapy Medicinal Products EMEA/149995/2008
• The Council Directive 93/42/EEC on Medical Devices
• Guideline on the use of statistical signal detection methods in the EudraVigilance data analysis system, EMEA/106464/2006 rev.1, adopted Jun 2008
• Guideline on strategies to identify and mitigate risks for first in human clinical trials with investigational products, EMEA/CHMP/SWP/28367/07, Sep 2007
• WHO/EDM/QSM/2002.2, Safety of Medicines, A guide to detecting and reporting adverse drug reactions
• Bradford Hill Criteria, Proc R Soc Med (1965) 58:295-300
• Draft FDA Guidance for Industry “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications”, Sep 2009
• Strategic Plan for Risk Communication at the Food and Drug Administration, Fall 2009
• FDA Guidance for Clinical Investigators, Sponsors, and IRBs, Adverse Event Reporting to IRBs — Improving Human Subject Protection, Jan 2009
• Federal Register / Vol. 73, No. 60 / Thursday, March 27, 2008 / Notices
• Food and Drug Administration Amendments Act (FDAAA) 2007
• FDA Reviewer Guidance for a Clinical Safety Review of a New Product Application and Preparing a Report on a Review, Feb 2005
• FDA Guidance for Industry “Pre-marketing Risk Assessment”, Mar 2005
• FDA Guidance for Industry “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment”, Mar 2005
• FDA Guidance for Industry “Development and Use of Risk Minimization Action Plans”, Mar 2005
• FDA Guidance for Industry “Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report”, Aug 1997
• Drugs for human use, New Drugs CFR21 part 310
• Investigational new drug application CFR21 part 312
• Drugs for human use, Applications for FDA approval to market a new drug CFR21 part 314
• Biologics, biological products: General CFR21 part 600
• Medical devices, medical device reporting CFR21 part 803
• Medical devices, investigational device exceptions CFR21 part 812

 Last updated: May 2, 2011