Table of Contents
What is ICH and its guidelines?
ICH Guidelines were created by The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH aims to provide uniform standards for technical requirements for pharmaceuticals for human use. They are developed by regulatory and pharma industry authorities.
Which are the main guidelines of ICH?
The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories.
- Quality Guidelines.
- Safety Guidelines.
- Efficacy Guidelines.
- Multidisciplinary Guidelines.
Why do we use ICH guidelines?
The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration.
What are the ICH guidelines for pharmacovigilance?
The following principles underpin this guideline: • Planning of pharmacovigilance activities throughout the product life-cycle; • Science-based approach to risk documentation; • Effective collaboration between regulators and industry; • Applicability of the Pharmacovigilance Plan across the three ICH regions.
What is the primary purpose of the ICH E6 guideline?
The objective of this ICH GCP guidance is to provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
What is the primary purpose of the ICH e6 guideline?
What is ICH Good Clinical Practice?
The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.
What is the purpose of the ICH e6 GCP guideline?
What are ICH GCP guidelines?
What is the ICH guidance Q7 Good Manufacturing Practice Guidance?
The ICH guidance Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredientsis intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.
What is the purpose of the ICH quality guide?
It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment.
What is the ICH guidance for clinical trials of medicines?
This ICH guidance provides recommendations on special considerations that apply in the design and conduct of clinical trials of medicines that are likely to have significant use in the elderly. This question and answer (Q&A) document is intended to clarify key issues.
What is the ICH Q7 for APIs?
ICH Q7 also describes principles of GMPs to be applied in the manufacture of APIs for use in clinical trials (section 19) and for APIs manufactured by cell culture/fermentation (section 18). ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients