The objective is to build the through the EMP TC based on the current situation in capacity of regulatory experts on the continent terms of expertise and resources existing in regional progressively. [...] for continental assessments, the EMP-TC reviewed the lists of products jointly assessed so far by RECs and looked at products in the WHO PQ pipeline and at priority products under the EMA centralised process. [...] The EMP Harmonisation of Technical Requirements for TC will recognise the list as it is updated from time Pharmaceuticals for Human Use (ICH), the to time by the WHO without needing to revise this European Commission, the US Food and Drug Guidance document, provided that they still meet the Administration and the Ministry of Health, criteria prescribed under this document. [...] The four main types of The work done by the continental EMP TC is Noncommunicable diseases are: expected to contribute to access to quality-assured essential medicines necessary for the treatment and • Cardiovascular Diseases (like heart attacks prevention of the priority diseases in Africa and to and stroke), consider medicinal products meant for the treatment • Cancers, of rare and neglected dis. [...] where there is no regulatory or QA mechanism to do the following in respect of such products: Therefore, these new medicines/vaccines for emergencies at the continental level will be eligible ■ Conduct a risk-benefit assessment in the for continental assessment to quickly mobilise African populations, including the suitability of the expertise on the continent and use existing product information.
- Pages
- 11
- Published in
- South Africa
