7. Approval for clinical trials
8. Testing of drugs in the certified laboratories
9. The compliance with international guidelines
11. Issuing various types of licence related to drugs
Table 7.2: Drug regulatory authorities of different countries
Sr. no. Country Name of regulatory authority
1. USA Food and Drug Administration (FDA)
2. UK Medicines and Healthcare Products Regulatory Agency (MHRA)
3. Australia Therapeutic Goods Administration (TGA)
4. Brazil Agencia Nacional de Vigiloncia Sanitaria (ANVISA )
Table 7.1: Chronological evolution of regulatory affairs (Contd.)
9. 1975 Two council directives by European Community:
1. First on the approximation of laws of member states which is related
to analytical, pharmacotoxicological standards and protocols for the
testing of proprietary medicinal products.
2. On the approximation of provision laid down by laws, regulation
and administrative action related to medicinal products
10. 1989 International Conference of Drug Regulatory Authorities was organised
12. 1993 Establishment of the European medicine evaluation agency (EMEA)
Regulatory Affairs and its Role 117
Table 7.2: Drug regulatory authorities of different countries (Contd.)
Sr. no. Country Name of regulatory authority
6. China State Food and Drug Administration
7. Costa Rica Ministry of Health
8. Denmark Danish Medicines Agency
9. Europe European Medicines Agency (EMEA)
10. Germany Federal Institute for Drugs and Medical Devices
11. Hong Kong Department of Health: Pharmaceutical Services
12. India Central Drug Standard Control Organization (CDSCO)
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