In many countries with limited regulatory resources, registration of finished pharmaceutical products (FPPs) — be these WHO-prequalified products or products approved by stringent regulatory authorities — can take considerable time. In the worst cases, this time can extend to two or three years, meaning that patients may not receive treatment that could save their lives or improve their state of health.
WHO has responded to this situation:
- firstly by creating a collaborative procedure to facilitate the assessment and accelerated national registration of WHO‑prequalified pharmaceutical FPPs
- secondly by creating a collaborative procedure to accelerate registration of FPPs that have already received approval from a stringent regulatory authority.
The procedure for stringently-approved FPPs was drafted taking into account the experience gained during development, testing and implementation of the procedure for prequalified FPPs. Thus the procedure for prequalified FPPs is fully operational, whereas the procedure for stringently-approved FPPs is in its pilot phase.
As well as aiming to ensure that much-needed medicines reach patients more quickly, both procedures incorporate strong elements of capacity building and regulatory harmonization. Successful of application of both procedures is highly dependent on the ability and willingness of pharmaceutical companies (the applicants), regulatory authorities and WHO to work together to meet public health goals.