UK Pharmaceutical Industry Association Revises Guidelines for Phase I Trials

GMP News
26 September 2007

UK Pharmaceutical Industry Association Revises
Guidelines for Phase I Trials

Although not legally binding, the 2007 edition of the Guidelines for Phase 1Clinical Trials gives comprehensive guidance for the development of newmedicines and their use in phase 1 clinical trials. According to ProfessorSir Gordon Duff, Chairman of the Expert Working Group which advised theestablishment of the revision, "the 2007 edition of the ABPI Guidelines forPhase 1 Clinical Trials is science based, and is a remarkably thorough andnotably clear compilation of up-to-date information and guidance on bestpractice".

The Association of the British Pharmaceutical Industry (APBI) guidelines goback to the early 70s and experienced some revisions over the years, takinginto account new aspects like the report on research in healthy volunteersof the Royal College of Physicians (RCP).

The 49 pages of the 2007 edition cover all key points for the development,investigation and regulation of new medicines with respect to phase 1clinical trials.
Here is an extract of the contents:

  • Overview of applicable regulations
  • Types of phase 1 trials and different IMPs
  • Risk assessment and management
  • Dosing
  • Various premises, facilities and staff
  • Training
  • Trial subjects
  • Safety
  • CTA application
  • Inspections
  • IMP manufacturing
  • Biotechnology products and Radioactive substances
  • IMP Supply
  • General study management
  • Qualified Person
  • Compensation, indemnity and insurance
  • Pharmacovigilance
  • Data management, statistics, report and publication
  • Essential documents, trial master file and archiving
  • Project management and monitoring
  • Quality management

You can find the document under following link:

Source: Association of the British Pharmaceutical Industry
The Association of the British Pharmaceutical Industry (ABPI) is the tradeassociation for pharmaceutical companies in the UK producing prescriptionmedicines. The ABPI also represents companies engaged in the research and/ordevelopment of medicines for human use.

Hear essential aspects about the organisation andmanagement of clinical trials, IMP distribution and things to considerduring the study in the European Compliance Academy's education course

During this course, the important interfaces between GMPand GCP will be elaborated.

Hear more about the role of the Qualified Person in thefield of Investigational Medicinal
Products in this year's QP Forum Pre-Conference Workshop

This conference is conducted by the European QPAssociation.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)


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