Table 2.

Organisation of the six regulatory agencies of the BRICS-TM.

	ANVISA (Brazil)	RUSSIA MoH	CDSCO (India)	SAHPRA (South Africa)	TITCK (Turkey)	COFEPRIS (Mexico)
Total agency staff	1,500	930	1,500	>200	1,172	2,000
Resource allocation in Biologic/Biosimilar division
Total staff	24	Not defined*	30	10	No information available	20
Number of reviewers	24	Not defined*	8	5	No information available	13
Capacity (%)	1.6	Not applicable	2	5	Not applicable	1
Internal assessors
Qualification	Ph.D.	M.Sc. to Ph.D.	M. Pharm#	4-year degree to Masters	Experienced, M.Sc., PhD	Bachelor's degree
Segregation by expertise	CMC, Non-clinical, Clinical, Other scientists	No information available	CMC, Non-clinical, Clinical, Microbiologist, Statistician, Assistant Drug Controllers	CMC, Clinical, Microbiologist	CMC, Non-clinical, Clinical, Microbiologist Other scientists, Project manager	CMC, Non-clinical, Clinical, Project manager
External assessors
Support received	No	No information available	Yes	Yes	Yes	Yes
Area of expertise	Not applicable	Not applicable	Non-clinical, Clinical	CMC, Non-clinical, Clinical	CMC, Non-clinical, Clinical	CMC, Non-clinical, Clinical
Biosimilar advisory committee	No	No information available	SEC, RCGM DBT	Biological Medicine Expert Advisory Committee	No	SEPB, NMC
Data assessment
Data Assessment type	Type III	Type III	Type II, III	Type III	Type III	Type I, III
Recognised reference agencies	Not specified	Not specified	EMA, USFDA, BRDD, MHRA, TGA	Not specified	Not specified	EMA, USFDA, TGA

^*No separate biologic division;

^#RCGM and SEC committee details excluded; CMC, Chemistry, Manufacturing and Control; SEC, Subject Expert Committee; RCGM, Review Committee on Genetic Manipulation; DBT, Department of Biotechnology; SEPB, Subcommittee on evaluation of Biotech Products; NMC, New Molecule Committee.