- What are ICH guidelines?
- What are different types of ICH guidelines?
- What are ICH countries?
- What is ICH guidelines for PV?
What are ICH 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.
What are different types of ICH guidelines?
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.
What are ICH countries?
Regulatory Members
- ANVISA, Brazil.
- HSA, Singapore.
- MFDS, Republic of Korea.
- NMPA, China.
- SFDA, Saudi Arabia.
- TFDA, Chinese Taipei.
- TITCK, Turkey.
What is ICH guidelines for PV?
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.