
Brazil, Russia, India, China, South Africa, Turkey and Mexico
World Health Organization
Rest of the world /Emerging Markets
United States
European Union
Australia, Canada, United Kingdom, Singapore and Switzerland
Import & Manufacture of New Drugs (CDSCO/SLA)
Registration & Import Licenses (CDSCO/ SLA)
Preclinical Protocol and Report submission & Approval (RCGM)
Clinical trial Protocol and Report Submission & Approval (CDSCO/DCGI)
Sample testing & Batch Release Certificate (CDL, Kasauli)
Marketing Authorization Application Submission & Approval (CDSCO/ DCGI)
Submission to WHO Prequalification programme (PQP) for Biologics
Submission to WHO Prequalification programme (PQP) for Biologics
Based on Stringent regulatory agency (SRA) approval (1) Full assessment pathway (2) Abridged assessment pathway
Based on Stringent regulatory agency (SRA) approval (1) Full assessment pathway (2) Abridged assessment pathway
GMP inspection/ Sample analysis (depends on the filing pathway)
GMP inspection/ Sample analysis (depends on the filing pathway)
Product dossier assessment by WHO
Product dossier assessment by WHO
Products assessed and placed in WHO’s list of prequalified medicines
Products assessed and placed in WHO’s list of prequalified medicines
Accelerated registration in other low-and-middle-income countries (LMICs)
Accelerated registration in other low-and-middle-income countries (LMICs)
Enables procurement by many NRAs and other UN agencies
Enables procurement by many NRAs and other UN agencies
The ‘ACSS’ consortium, formed in 2007, comprises of the national regulatory authorities of Australia, Canada, Singapore and Switzerland. ACCESS – In October 2020, the United Kingdom regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – joined the consortium and the group’s name was changed to ‘Access’. The consortium’s goal is to maximize international cooperation, reduce duplication, and increase each agency’s capacity to ensure patients have timely access to high quality, safe and effective therapeutic products. Pharmaceutical companies that submit applications to some or all Access countries will benefit from having their products evaluated for marketing in those countries simultaneously, with reduced evaluation times.