Guideline on Good Clinical Practice (GCP GL) was one of the first of the efficacy guidelines which was developed in the VICH process besides the anthelminthic guidelines. Both the EU and USA had their own GCP guidelines in force when the VICH work on Good Clinical Practice guidance started. The EU guideline had been adopted in 1991 (7AE1a in Volume 7A; http://pharmacos.eudra.org/F2/eudralex/vol-7/A/7AE1a.pdf ) and the US Conduct of Clinical Investigations: Responsibilities of Clinical Investigators and Monitors for Investigational New Animal Drug Studies had been adopted in 1992, thus quite a lot of experience had been gained from these guidelines during the previous 5-6 years. On the other hand in 1997, when VICH GCP Working Group (VICH GCP WG) started its work, no GCP guideline was in force in Japan but the guidance document was under preparation (Good Clinical Practice for Trials on Veterinary Drugs, draft).
Dr. Vic Cracknell from FEDESA was appointed as the topic leader for the VICH GCP WG. The EU, Japan and USA had two experts appointed in the WG - one representing the regulatory authority and one representing the veterinary medicine industry:
Authorities:
USA/FDA
EU
Japan MAFF
Industry:
AHI
FEDESA
Japan JVPA
Expert from New Zealand and Australia participated as observers in the work of the group.
Besides chairing and organising the first Working Group meeting the Topic Leader was responsible to produce the concept paper for the VICH GCP Guideline. The VICH Steering Committee had suggested that the EU GCP guideline should be taken as basis for the harmonisation work. The first document was circulated to the WG members on 9th January 1997. The major items which should be subject for harmonisation were as follows:
- Structure and content of clinical study reports i.e. single world-wide core clinical study report should be acceptable to all regulatory authorities
- Documents permitting evaluation of the conduct of a trial and the quality of the data produced i.e. demonstration of compliance with the standards of Good Clinical Practice
- Definition of site investigator responsibilities - personal liabilities
- Definition of monitor function
- Inspection/auditing and quality assurance
- Necessity of pre-trial protocol review
As a part of authority process in the EU CVMP requested the nominated expert, prof. Satu Pyörälä, to give her views of the concept document before the first VICH GCP Working Group meeting. From the EU point of view it could be concluded that the majority of the elements could be found from the existing EU guideline. Prof. Satu Pyörälä considered that auditing process and quality assurance is likely to be the most difficult issue. Also animal welfare needs to be addressed in the document.
The first VICH GCP WG meeting took place in Brussels on 6-8 May 1997. The Working Group was successful and all the topics could be discussed and many of them were also agreed. Animal welfare issues were also discussed. These were missing from the existing EU guideline but could be found from the US guideline. Also some other points were adopted from the US guideline or from the draft Japanese guideline. Working Group members utilised the electronic exchange of views effectively between the meetings in order to enhance the development of the guideline.
The second VICH GCP WG meeting took place in Bethesda, Maryland, USA on 9-12 March 1998. Dr. M. Schoenemann, FDA took very active role in assisting effectively the revision of the draft guideline. The VICH Steering Committee had suggested that the working group concentrate their effort on pharmaceutical products because it was recognised that in the USA the FDA was only responsible for pharmaceuticals. The US Department of Agriculture (USDA) was not participating in the VICH process at this point thus the regulatory authority for biological animal health products was missing from the WG.
The draft VICH GCP GL was signed for release for consultation by the VICH Steering Committee (step 4) in October 1998. In the EU CVMP release the document for 6-month consultation in the EU in December 1998.
During the consultation process the USDA got involved with the VICH process, thus VICH GCP GL could also cover immunological products in a future.
After the consultation the chairmanship of the WG was transferred from industry to the regulatory authority; Dr. Schoenemann, FDA, chaired the post-consultation meeting. The third VICH GCP Working Group meeting took place in Brussels on 15-16 November 1999 just ahead of the first VICH conference. Several parties had provided comments during consultation period. Most of the discussions involved auditing and quality assurance issues. Another "hot" topic was animal welfare - not only the investigator but also the sponsor has responsibility on welfare. The WG finalised the guideline and signed it (Step 5). The VICH Steering Committee signed the guideline (Step 7) in February 2000. The CVMP gave its final approval in July 200 and the date for coming into operation in the EU was in July 2001 (http://www.emea.eu.int/pdfs/vet/vich/059598en.pdf).
