Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The WHO Collaborative Registration Procedure for Medicines in Developing Countries ***

Dr. Stefanie Haas (Abschlußjahr: 2015)

Summary
Medicine regulation is a challenging, sophisticated and resource-demanding task. However, NMRAs in developing countries have to cope with very constrained resources regarding adequately trained staff, expertise and funding. Hence, circulating substandard and counterfeit medicines are not detected and consequently commonly distributed and dispensed. Furthermore, some urgently needed drugs are not available on the local market for the patient population. Due to the fact that neither the government nor the people can afford high-priced medicines, innovative pharmaceutical companies are rarely interested in marketing their medicinal products in developing countries. Additionally, in the past the quality of several generic products was doubted. Unfortunately, this could not be addressed and monitored adequately by the NMRAs because of their restricted resources.
To enable UN agencies to purchase high-quality, safe and efficient medicines at reasonable prices address, the WHO established the prequalification programme in 2001. This approach improved the situation in developing countries tremendously. Nevertheless, prequalification does not result in a national marketing authorisation and consequently required medicines are still not accessible for all patients via the regular distribution chain. This approach improved the situation in developing countries tremendously. That is why the WHO started a pilot project in 2012 to foster drug registration in developing countries. This collaborative registration procedure (CRP) not only aims to accelerate the authorisation process but also focuses on capacity building at the NMRA. Trainings, workshops and joint activities extend expertise as well as experience of local assessors and inspectors. Furthermore, the CRP programme promotes harmonisation and thereby the reduction of regulatory burden for the NMRAs as well as for the manufacturers.
This thesis describes the historical context that led to the establishment of the CRP. It further summarises experiences and achievements of the first 2.5 years and discusses advantages and drawbacks as well as the potential development of the programme in the future.
Pages: 61