Whilst I know several clients would consider this “old hat”, it's always good to start at the beginning. I remember hearing about the development of Ivermectin during a presentation at the beginning of my career and being totally captivated! If you are unfamiliar google “ivermectin, golf course”! Anyway, I digress…
vGCP Trials and Tribulations! So We Start at the Beginning Part 1: VICH GCP Explained in a Nut Shell!
October 7, 2024
“What is VICH GCP?” - Surprisingly, I get asked this, A LOT!
Whilst game-changing blockbusters are rare, this is the aim, and to get there we conduct studies according to the VICH GCP guideline (alongside a plethora of pre-clinical efficacy and safety GLP work and of course GMP manufacturing of products, but one blog-topic at a time, right?!).
VICH GCP or Veterinary International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) Good Clinical Practice (GCP), is a guideline designed to ensure the quality, safety, and efficacy of veterinary medicinal products. The VICH Good Clinical Practice (GCP) guideline, known as VICH GL9, was first issued in June 2000 and became effective in July 2001.This guideline was developed to harmonise the design and conduct of clinical studies for veterinary products across different regions, including the EU, Japan, USA as well as other interested countries.
The VICH?
“VICH” is an international program that brings together regulatory authorities to develop harmonised (standardised) requirements for the registration of veterinary medicinal products.
The GCP?
“GCP” specifically focuses on the conduct of clinical trials across different regions, thereby facilitating the mutual acceptance of clinical trial data by participating regulatory authorities.
This harmonisation aims to reduce the need for duplicative studies, streamline the drug development process, and ultimately lead to more efficient global regulatory decision-making.
As a rule all pivitol clinical studies are performed to VICH GCP.
Human vs Veterinary? ICH-GCP vs. VICH GCP?
Just in case there is confusion, the VICH GCP guideline is based on the principles of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) GCP, which are widely recognised and adopted in the human pharmaceutical industry.
However, VICH GCP is tailored to address the unique aspects of veterinary medicine, including animal welfare, species differences, and the diversity of conditions and practices in veterinary clinical settings.
Why Control Drug Development?
Protect Public Health and Safety: Early in the 20th century, the unregulated sale of drugs led to widespread health issues and fatalities. For example, the Thalidomide scandal in the 1960s, where a drug caused severe birth defects, highlighted the need for stringent regulations.
Ensure Efficacy and Quality: To ensure that drugs are effective and of high quality, regulations were introduced. This includes rigorous testing and clinical trials before a drug can be approved for use.
Prevent Abuse and Misuse: The rise in drug abuse and addiction led to laws controlling the distribution and prescription of certain substances.
Consider Economic and Ethical Concerns: Controlling drug development also helps prevent unethical practices by pharmaceutical companies, ensuring that they do not exploit consumers or engage in fraudulent activities.
Concluding Remark
By adhering to VICH GCP, the veterinary pharmaceutical industry and regulatory bodies can ensure that the data generated from clinical trials are reliable and that the rights, safety, and welfare of the animals involved are protected. This is crucial for the development of safe and effective veterinary medicines that contribute to public health and the well-being of animals.
Further reading:
Human ICH GCP
Veterinary VICH GCP (EU)
VICH Topic GL9 (GCP) (europa.eu)
Veterinary VICH GCP (US)
GFI #85 - VICH GL9 (GCP) (fda.gov)
Veterinary VICH GCP (Japan)
https://www.maff.go.jp/nval/english/regulatory/pdf/Outline_RegulatorySystem_VMPs.pdf
The recent RQA International QA Conference, themed "Foundations First: Quality Reconstructed," convened industry professionals in Brighton to explore innovative approaches to quality assurance. See our event highlights.
Pre-Clinical Studies - the need for VICH GCP compliance?
What does VICH GCP cover?..
Excited to be helping my colleagues with a workshop on "deviations". Also looking forward to hearing experiences of FDA-inspections in the EU. Another hot topic!
