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Good Clinical Practice Directive

The Good Clinical Practice Directive lays down principles and guidelines for conducting clinical trials of medicinal products for human use in the EU. It addresses good clinical practice for trial design, conduct, recording and reporting. It also addresses requirements for authorization of manufacturing or importing investigational medicinal products. The directive covers topics like the investigator's brochure, trial master files, inspectors and inspection procedures.

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81 views5 pages

Good Clinical Practice Directive

The Good Clinical Practice Directive lays down principles and guidelines for conducting clinical trials of medicinal products for human use in the EU. It addresses good clinical practice for trial design, conduct, recording and reporting. It also addresses requirements for authorization of manufacturing or importing investigational medicinal products. The directive covers topics like the investigator's brochure, trial master files, inspectors and inspection procedures.

Uploaded by

Deen
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
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Good Clinical Practice Directive

From Wikipedia, the free encyclopedia


  (Redirected from Directive 2005/28/EC)

Jump to navigationJump to search


The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the
European Parliament and of the Council) lays down principles and detailed guidelines
for good clinical practice as regards conducting clinical trials of medicinal products for
human use, as well as the requirements for authorisation of the manufacturing or
importation of such products.
The directive deals with the following items:

 Good clinical practice for the design, conduct, recording and reporting of clinical
trials:
o Good Clinical Practice (GCP)
o The Ethics Committee
o The sponsors
 Investigator's Brochure
 Manufacturing or import authorisation
o Exemption for Hospital & Health Centres and Reconstitution
o Conditions of Holding a Manufacturing Licence
 The Trial master file and archiving
o Format of Trial Master File
o Retention of Essential and Medical Records
 Inspectors
 Inspection procedures
 Final provisions

References[edit]
 Text of the directive: 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
 National implementing measures of the EU-countries

See also[edit]
 EudraLex
 Directive 65/65/EEC1
 Directive 75/318/EEC
 Directive 75/319/EEC
 Directive 93/41/EEC
 Directive 2001/20/EC
 Directive 2001/83/EC
 Regulation of therapeutic goods
 European Medicines Agency
 Common Technical Document
Good Clinical Practice Directive
From Wikipedia, the free encyclopedia
  (Redirected from Directive 2005/28/EC)

Jump to navigationJump to search


The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the
European Parliament and of the Council) lays down principles and detailed guidelines
for good clinical practice as regards conducting clinical trials of medicinal products for
human use, as well as the requirements for authorisation of the manufacturing or
importation of such products.
The directive deals with the following items:

 Good clinical practice for the design, conduct, recording and reporting of clinical
trials:
o Good Clinical Practice (GCP)
o The Ethics Committee
o The sponsors
 Investigator's Brochure
 Manufacturing or import authorisation
o Exemption for Hospital & Health Centres and Reconstitution
o Conditions of Holding a Manufacturing Licence
 The Trial master file and archiving
o Format of Trial Master File
o Retention of Essential and Medical Records
 Inspectors
 Inspection procedures
 Final provisions

References[edit]
 Text of the directive: 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
 National implementing measures of the EU-countries

See also[edit]
 EudraLex
 Directive 65/65/EEC1
 Directive 75/318/EEC
 Directive 75/319/EEC
 Directive 93/41/EEC
 Directive 2001/20/EC
 Directive 2001/83/EC
 Regulation of therapeutic goods
 European Medicines Agency
 Common Technical Document
Good Clinical Practice Directive
From Wikipedia, the free encyclopedia
  (Redirected from Directive 2005/28/EC)

Jump to navigationJump to search


The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the
European Parliament and of the Council) lays down principles and detailed guidelines
for good clinical practice as regards conducting clinical trials of medicinal products for
human use, as well as the requirements for authorisation of the manufacturing or
importation of such products.
The directive deals with the following items:

 Good clinical practice for the design, conduct, recording and reporting of clinical
trials:
o Good Clinical Practice (GCP)
o The Ethics Committee
o The sponsors
 Investigator's Brochure
 Manufacturing or import authorisation
o Exemption for Hospital & Health Centres and Reconstitution
o Conditions of Holding a Manufacturing Licence
 The Trial master file and archiving
o Format of Trial Master File
o Retention of Essential and Medical Records
 Inspectors
 Inspection procedures
 Final provisions

References[edit]
 Text of the directive: 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
 National implementing measures of the EU-countries

See also[edit]
 EudraLex
 Directive 65/65/EEC1
 Directive 75/318/EEC
 Directive 75/319/EEC
 Directive 93/41/EEC
 Directive 2001/20/EC
 Directive 2001/83/EC
 Regulation of therapeutic goods
 European Medicines Agency
 Common Technical Document
Good Clinical Practice Directive
From Wikipedia, the free encyclopedia
  (Redirected from Directive 2005/28/EC)

Jump to navigationJump to search


The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the
European Parliament and of the Council) lays down principles and detailed guidelines
for good clinical practice as regards conducting clinical trials of medicinal products for
human use, as well as the requirements for authorisation of the manufacturing or
importation of such products.
The directive deals with the following items:

 Good clinical practice for the design, conduct, recording and reporting of clinical
trials:
o Good Clinical Practice (GCP)
o The Ethics Committee
o The sponsors
 Investigator's Brochure
 Manufacturing or import authorisation
o Exemption for Hospital & Health Centres and Reconstitution
o Conditions of Holding a Manufacturing Licence
 The Trial master file and archiving
o Format of Trial Master File
o Retention of Essential and Medical Records
 Inspectors
 Inspection procedures
 Final provisions

References[edit]
 Text of the directive: 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
 National implementing measures of the EU-countries

See also[edit]
 EudraLex
 Directive 65/65/EEC1
 Directive 75/318/EEC
 Directive 75/319/EEC
 Directive 93/41/EEC
 Directive 2001/20/EC
 Directive 2001/83/EC
 Regulation of therapeutic goods
 European Medicines Agency
 Common Technical Document

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