Dear all,
I am a microbiologist, furthermore i have done one project to find a antihepatitic compound from a plant. I want to do some further research on drugs and their manufacture. I need to strong in drug designing and manufacturing. Any one from such field can help and collabrate with me?. Atleast i welcome your valuable litral knowledge and web links. I eager to know the basic principle of drug manufacture. Thank you

Hello skarthikumar:

The drug approval process is a very long, difficult, and expensive venture. This website give a nice brief overview of The Drug Development and Approval Process



United States Drug Approval is governed by The Center for Drug Evaluation and Research (CDER) within the US Food and Drug Administration (FDA).

CDER Drug Approval Application Process




Within the European Union, the drug approval process is governed The European Medicines Agency (EMEA)

Here are some useful EU links -

Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials

Detailed guidance for the request for authorisation ofa clinical trial on a medicinal product for human use

Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use

Otherwise, you can purchase a A Guide to European Union Pharmaceutical Regulations: Practical & Political Perspectives of the Changing Environment



Within India, the drug approval process is governed by Central Drugs Standard Control Organization within the Ministry of Health and Family Welfare, Government of India



For drug approval in China, you can refer to this article - The Regulation and Approvalof New Drugs in China



Hope this helps - Good Luck!

Dear Tony Rook Sir,
I cordially thank for your useful links. It was very useful.