ROLE OF ICH GUIDELINES FROM ICH-Q1 to ICH-Q14 by Rajashri Ojha[Founder & Director Raaj GPRAC]

Role of ICH guidelines in registration of Pharmaceutical Products
The International Conference on Harmonization (ICH) of Technical Requirements is a unique project for Registration of Pharmaceutical products which are intended for human use. This brings together the regulatory authorities of Europe, Japan and United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
The purpose is to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.
The objective of such harmonization is a more economical use of human, animal and material resources and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy and regulatory obligations to protect public health. It creates a venue that allows all key pharmaceutical regulatory authorities and industry stakeholders the opportunity to be more actively involved in pharmaceutical harmonization work. It aimed at the standardization of requirements and format along with the content of regulatory documentation and brings down the pressure on the price of medicines by enabling greater economies of scale and a labelled regulatory playing field. This paper is an effort to provide the detailed information about ICH Guidelines.

[@elizabethholloway6945]

Wonderful content. Thank you for making it available to us.

[@ilmamajeed244]

Amazing explanation, concise but very informative.
Thank you Maam.

[@shyammahajan4098]

Thank you Ma'am Very Informative

[@RAMKUMAR-fb7gt]

Thanks for your information

[@rajahiwale]

Ma’am can you please share this ppt

[@usamakazi5808]

Mam calculated 3*3 on somewhere and it said it loudly, sorry😅 i was listening ur lecture with full concentration thats why i noticed it😂

[@shalinipoojary67]

Very informative mam,now ICH changes council to conference...can you please confirm this once...

[@RaajGpracRaajpharmaeLearning]

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.