National regulatory authorities (NRAs) are mandated to protect and promote public health by ensuring the timely availability of safe, effective, and quality medical products in line with international standards. The collective efforts of regulators and stakeholders are essential to achieve the desired public health goals considering that no single regulator, including the well-resourced authorities, can sufficiently perform all the required regulatory activities single-handed. World Health Organization (WHO) promotes information and work-sharing arrangements based on this principle of collaboration and reliance on the work products of trusted authorities and institutions to inform regulatory decision-making. The facilitated regulatory pathways described cover marketing authorization (registration), and post-registration maintenance for both innovative medical products (pharmaceuticals and biotherapeutics), generic and similar biotherapeutic products. The underlying principles of these facilitated regulatory pathways include:

• timely and equitable access to quality-assured products; 
• science-based, risk-based, transparent regulatory decision-making;
• better use of available, often limited, regulatory resources on value-added regulatory processes;
• reducing duplication of efforts and resources  through reliance on the  work products (such as relevant inspection reports and scientific assessments) of trusted counterpart regulatory agencies and WHO Prequalification Team (WHO PQT) to inform local regulatory decision-making;
• respecting national sovereignty. 

The regulatory pathways available to facilitate marketing authorization in WHO Member States and product sponsors are (1) collaborative registration procedure for WHO-prequalified products; (2) collaborative registration procedure for products approved by reference authorities “stringent regulatory authorities” ; (3) collaboration within regional economic communities in the context of regional harmonization; and (4) bilateral agreements between NRAs (confidentiality, unilateral or mutual recognition). 

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