Downloads:

1) ICH

2) FDA documents

3) EMEA documents

4) EC documents

ICH

E6(R1): Good Clinical Practice : Consolidated Guideline

E8: General Considerations for Clinical Trials

E9: Statistical Principles for Clinical Trials 

FDA

FDA Regulations Relating to Good Clinical Practice and Clinical Trials

Regulatory & Scientific Guidances

• Human Drug Current Good Manufacturing Practice Notes.  Human Drug Current Good Manufacturing Practice Notes is a periodic memo on Current Good Manufacturing Practice issues on human use pharmaceuticals, issued by the Division of Manufacturing and Product Quality.

• Drugs Marketed in the United States That Do Not Have Required FDA Approval

Legislation

• The Food and Drug Administration Amendments Act of 2007
• Federal Register (FDA). FDA-related material published in the Federal Register.
• Federal Register (GPO).  An external link to the entire text of the Federal Register (1995-current) on the Government Printing Office web site.

• CDER Drug Product Applications.   What you need to know to file applications for a regular or an emergency investigational drug product, a new drug, or a generic drug.
• CDER Small Business Assistance Program. What you need to do to file an application for marketing a new drug product. 
• Institute Review Board Operations and Clinical Investigation Requirements.  This FDA Office of Public Affairs page provides information on IRB operations and clinical requirements.
• International Conference on Harmonization: Electronic Standards for the Transfer of Regulatory Information
• Investigational Human Drugs: Clinical Investigator Inspection List
• Required Specifications for FDA’s IND, NDA, ANDA, Drug Master File Binders

International Activities

• International Conference on Harmonization: Electronic Standards for the Transfer of Regulatory Information

Compliance Activities

• Disqualified/Restricted/Assurance List for Clinical Investigators
  This list contains the names of all investigators who have at one time been disqualified, restricted, or have made assurances in their use of investigational products.
• Drug Application Regulatory Compliance
• Drug Registration and Listing
  • Drug Firm Annual Registration Status
• Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations
• Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

EMEA

EudraCT Supporting Documentation

Directives Directive 2001/20/EC of the European Parliament and of the Council

Guidance Documents

EudraLex Volume 10 - Clinical trials
EudraCT - Detailed guidance on the European clinical trials database
CT Application - Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use

Forms ( English only )

Clinical Trial Application Form
N.B. This is for reference only and must not be used to create xml files.
To complete the Clinical Trial Application Form and generate the required xml and pdf files
go to Access to Eudract

  Section J. (Formerly Section K)

Check List of the information appended to the Application Form   Notification of Amendment   Declaration of the end of a Clinical Trial  

User Guides ( English only ) EudraCT Frequently Asked Questions   EudraCT User Manual   Member States' Contacts List   EudraCT - Member State Competent Authorities Clinical Trial Contacts
Useful Links   MedDRA - the Medical Dictionary for Regulatory Activities
MedDRA - Presentation
ATC - WHO Anatomical Therapeutic Chemical Codes
ICD - The International Statistical Classification of Diseases and Related Health Problems
ISRCTN - International Standard Randomised Controlled Trial Numbers
CAS Numbers - The largest and most current database of chemical substance information in the world containing more than 23 million organic and inorganic substances and 41 million sequences EMEA is not responible for the content of external sites

EC

EudraLex - Volume 10
Clinical trials guidelines

Volume 10 of the publications “The rules governing medicinal products in the European Union” contains guidance documents applying to clinical trials.

Chapter I : Application and Application Form

- General information (July 2006)

- Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial (revision 2 of October 2005)

• Annex 1 : "Clinical trial application form" - (revision 2 of October 2005)
• Annex 2 : "Substantial Amendment Form" - (revision 2 of October 2005)
• Annex 3 : "Declaration of the end of the trial" - (revision 2 of October 2005)

Note: The following version of the guidance will be applicable only once the EudraCT database Version 7 has been released. This is expected for Q1 2009.

• Annex 1 : "Clinical trial application form" - (revision of June 2008)
• Annex 2 : "Substantial Amendment Form" - (revision of June 2008)
• Annex 3 : "Declaration of the end of the trial" - (revision of June 2008)

 - 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 (revision 1 of February 2006)

- Detailed guidance on the European clinical trials database (EUDRACT Database) (revision of April 2004)

Chapter II : Monitoring and Pharmacovigilance

- Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use ( revision 2 of April 2006)

- Detailed guidance on the European database of Suspected

nexpected Serious Adverse Reactions (Eudravigilance – Clinical Trial Module) (revision 1 of April 2004)

Chapter III : Quality of the Investigational Medicinal Product

- Good manufacturing practices for manufacture of investigational medicinal products (July 2003)

- Community basic format for manufacturing authorisation / Community basic format for manufacturers / importers

- Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials

- Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials

Chapter IV : Inspections

Guidance for exchange of GCP Inspection Reports according to Directive 200120EC art 15.2 (June 2008)
Guidance for the communication on GCP inspections and findings (June 2008)
Guidance for the conduct of GCP inspections (June 2008)
     Annex I to Guidance for the conduct of GCP inspections - investigator site (June 2008)
     Annex II to Guidance for the conduct of GCP inspection - clinical laboratories (June 2008)
     Annex III to Guidance for the conduct of GCP inspections - computer systems (June 2008)
     Annex IV to Guidance for the conduct of GCP inspections - Sponsor and CRO (June 2008)
Guidance for the preparation of GCP inspections (June 2008)
Guidance for the preparation of Good Clinical Practice inspection reports (June 2008)
Full set zip format- Recommendations on the qualifications of inspectors verifying compliance in clinical trials with the provisions of Good Clinical Practice (July 2006)

Chapter V : Additional Information

- Guidelines on good clinical practice (ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95) (1996)

- Recommendation on the content of the trial master file and archiving (July 2006)

- Guideline on the data fields from the European clinical trials database EudraCT) that may be included in the European database on Medicinal Products (July 2008)

- QUESTIONS AND ANSWERS (25 April 2005)

- Ethical considerations for clinical trials on medicinal products conducted with the paediatric population (2008)

Chapter VI : Legislation

- 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 (Official Journal L 121, 1/5/2001 p. 34 - 44)

 - 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 (Official Journal L 91, 9/4/2005 p. 13 - 19)

 - 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 ).

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 (Official Journal L 91, 9/4/2005 p. 13 - 19 ).

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 (Official Journal L 121, 1/5/2001 p. 34 - 44

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 (Consolided version : 21/03/2008).

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).

Regulation (EC) No 726/2004

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With our 5 years of experience in increasing our partners' return on investment we've developed winning strategies guaranteed to build and sustain successful partnerships in clinical trials outsourcing.

• pharmaceutical companies
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NBScience already has many partnerships with societies, universities, statutory organisations and NGOs locally, nationally and internationally. We aim to strengthen these relationships and develop new collaborations in the future.