Guideline for Registration of Vaccine

The Ethiopian Food, Medicine and Healthcare Administration and Control Authority is mandated
by the proclamation N o . 661/2009 to ensure the safety, quality and efficacy of medicines. Vaccines
are pharmaceutical products that fall in this jurisdiction that must be available in the market of
Ethiopia of required safety, quality and effectiveness.
Vaccines are products of biological origin that exhibit some intrinsic variability. They are
characterized by complex manufacturing processes and are administered to large numbers of
healthy children, adolescents and adults. The quality of a vaccine cannot be assessed solely by
testing the final product alone. Hence, specific regulatory systems for vaccines should also be
strengthened.
A basic function of the Authority is to evaluate the quality, safety and efficacy of vaccines for
human use. In order to license a vaccine for human use, the Authority must first set requirements
for applicants to comply with. These requirements include (i) information needed for the
application; (ii) evidence that the vaccine has passed the stages of research, development,
production and quality control; (iii) evidence from clinical testing, and (iv) evidence that quality,
safety and efficacy of the vaccine has been established.
Another important aspect to consider in the vaccine evaluation process is that the manufacturing
facilities must comply with Good Manufacturing Practices (GMP).
The document is adapted from Guidance Document Harmonized Requirements for the Licensing
of Vaccines and Guidelines for the Preparation of an Application, Health Canada, 2016 and is
based on the requirements of the International Conference on Harmonization (ICH) Common
Technical Document (CTD) and the Technical Report Series of the World Health Organization.
This document consists of five modules, following the guidelines established by the ICH CTD,
adapted specifically to the registration of vaccines. For those vaccines approved by stringent
regulatory authorities, this guideline also pointed out the specific requirements during dossier
review process as indicated in Annex IV.
All users of this guideline are strongly invited to forward their comments and suggestions to the
Food, Medicine and Healthcare Administration and Control Authority of Ethiopia, P.O.Box 5681,
Tel. 251-11 552 41 22, email: regulatory@fmhaca.gov.et, Addis Ababa, Ethiopia