Data Sources for Continental API Database

Sources of Information

a) EMP TC and GMP TC

Records of approved APIs following joint evaluation and joint GMP inspections, including AMA RIMS.

b) Recognized RECs processes

Processes for API approval, such as Regional APIMF procedures.

c) Recognized NRAs

NRAs with WHO ML3 and above from the continent.

d) WHO PQ Scheme

Participation in the WHO Prequalification (PQ) scheme.

e) Stringent Regulatory Authority

Access to inspection and evaluation reports assured through agreement with AMRH.

f) Trusted Website Links

Links from trusted websites such as WHO, EDQM, for public domain and manufacturers.