Major Regulatory Bodies
1) United States Food and Drug Administration (FDA):
Regulates drugs, biologics, and medical devices in the USA.
Provides guidelines on GMP, validation, and TT.
2) European Medicines Agency (EMA):
Oversees medicinal products in the European Union.
Issues directives on manufacturing and quality assurance.
3) Medicines and Healthcare products Regulatory Agency (MHRA):
UK's regulatory body for medicines and medical devices.
4) Therapeutic Goods Administration (TGA):
Regulates therapeutic goods in Australia.
5) Central Drugs Standard Control Organization (CDSCO):
India's national regulatory body for pharmaceuticals.
Here's a concise table summarizing the major regulatory bodies
Regulatory Body | Region | Primary Functions |
FDA | USA | Regulates drugs, biologics, and devices; provides GMP guidelines |
EMA | European Union | Oversees medicinal products; issues manufacturing directives |
MHRA | United Kingdom | Regulates medicines and medical devices |
TGA | Australia | Regulates therapeutic goods |
CDSCO | India | National regulatory body for pharmaceuticals |
Role in Technology Transfer
Guidance Documents: Provide frameworks and guidelines for TT activities.
Inspections and Audits: Ensure compliance with regulations during and after TT.
Regulatory Submissions: Approve changes resulting from TT processes.
Guidelines Provided
GMP Guidelines: Standards for manufacturing practices.
ICH Guidelines: Harmonized guidelines on quality, safety, and efficacy.
TT Specific Guidelines: Detailed recommendations on conducting technology transfers.