VICH GOOD CLINICAL PRACTICE GL 9 (VICH-GCP)
TABLE 1: SUMMARY OF RESPONSES COLLECTED REGARDING VICH-GCP INSPECTION PROGRAMMES IN EU
VICH Good Clinical Practice GL 9 (VICH-GCP) is an international guideline recognized by most companies and health authorities dealing with veterinary medicines.
VETERINARY GOOD CLINICAL PRACTICE INSPECTIONS IN THE EUROPEAN UNION RQA Animal & Veterinary Product Committee (A&VPC).
Responses Received from Health Agencies
Responses Received from Regulatory Professionals
Belgium (Starting 2017)
Austria
Denmark
Spain
Poland
Sweden
Estonia
Greece
Lithuania
Bulgaria
Latvia
France
Portugal
Finland
• Can you please specify the reference text (Inc. section) where this is stated?
The Netherlands
United Kingdom
• Does the national health agency have an inspection programme to assess the VICH-GCP compliance of clinical studies conducted in the country?
Ireland
Germany
Slovakia
Romania
While there is an inspection program in the United States, the implementation and conduct of such inspections across the European Union is unclear. As an attempt to clarify the situation, a simple questionnaire was sent to regulatory professionals and national health authorities of all the EU countries.
LIST OF QUESTION SENT TO EU HEALTH AGENCIES AND REGULATORY PROFESSIONALS:
GCP Inspection in Place
No GCP inspection
• Is VICH-GCP mandatory for the conduct of clinical trial in your country according to national law?
• Is this inspection programme effective and have any inspections already been conducted? • If yes, please specify the type of inspection (investigator site, Sponsor site, study report only or a combination of).
RESULTS:
Italy Unclear
Hungary
No answer received
Slovenia
Croatia
Luxembourg
Malta
23 out of 28 countries replied. Regardless of the existence of an inspection programme or not and as anticipated, most of the countries have transcribed Directive 2001/82/EC into national law which makes VICH-GCP mandatory for the conduct of clinical trials almost everywhere in the European Union. Relevant health Authority of each country expects the clinical trial authorization (and the protocol in the countries where the final protocol should be submitted for ATC as well) to specifically claim that the clinical trial will be conducted according to VICH-GCP.
Czech Republic
While VICH-GCP GL9 is recognized by CVMP, very few countries officially inspect veterinary clinical trials for VICH-GCP compliance. The recent experiences of clinical study inspections show that this is mostly done by local veterinary offices based on other grounds than VICH-GCP compliance specifically. However it seem that there are on-going discussions in several countries to establish such programmes, therefore organisations considering initiating multi-national clinical trials across the EU with claims of GCP compliance may wish to consider strategies for becoming inspection-ready in the future. The RQA AHC has contacted the CVMP with the same question and is waiting for clarification.
RQA Animal & Veterinary Product Committee (A&VPC).
4 Health Agencies confirmed that there’s an inspection programme in place and 7 confirmed that such inspection programme does not exist in their respective country. Several Regulatory Professionals also stated that inspections of clinical trials are conducted in their country by the authorities. However: • While several National Health Authorities do have a mandate for inspection, the programs themselves have never been really implemented;
Sven Buckingham
Karl Butler
Iain Mcphee
Arnaud Pibaleau
Nikki Potgieter
Lindsay Heasman
Antonia Goetze
Marci Murphy
Leonora Pearson
Donna Taylor
Nana Tawiah
Shona Ross
• Some inspections are not real GCP inspection but veterinary service inspection by local veterinary authorities. These services will focus more on Animal Welfare, compliance of the medicine pharmacy; however they may also inspect some component (Clinical trial authorization, withdrawal period) of a clinical study.