The Authority introduced a process for expedited review of applications for registration. However, it is important to note that this does not mean that other applications will not be reviewed in a timely manner, but rather that the Authority has developed a separate channel to expedite the review of applications should applicants elect this route.
Applicants will note that in the current fee schedule, (Statutory Instrument 186 of 2012), which is available on the MCAZ website (www.mcaz.co.zw), there is a higher fee prescribed for expedited reviews. This is because the Authority has to outlay more resources to see this process through. Again, it must be noted that all applications already received will continue to be reviewed as expeditiously as possible.
Applicants should note that the expedited review process is currently suspended and applicants would be informed once this route is activated.
(ii) WHO Collaborative Registration Procedure
Since June 2012, MCAZ has been participating in the WHO Collaborative Registration Procedure for prequalified products. This collaborative procedure serves to facilitate and accelerate registration of products which WHO Prequalification Team-Medicines (WHO/PQTm) has already assessed and prequalified. This is done through confidential sharing of WHO/PQP assessment and inspection outcomes with the Authority at the manufacturer’s request. The information is shared via a secure internet-based platform, subject to agreed restrictions on use and confidentiality undertakings. It is expected that through this route MCAZ will reach a decision on registration within 90 days, and communicate it within a further 30 days.
All applicants with WHO prequalified products are encouraged to use this route. The applicants should note that the product submitted for national registration must be in all essential features the same as the prequalified product. Minor administrative differences are allowed to reflect local labelling and other regulatory requirements. The national rules for submission of applications and regulatory fees apply when this procedure is used. Applicants can use the same dossier as approved during prequalification.
Further information and required forms can be obtained from www.who.int/prequal Collaborative Procedure.
Reference: WHO Technical Report Series 981, 2013 - Annex 4
(iii)ZAZIBONA Collaborative Medicines Registration Process
ZAZIBONA collaborative registration procedure and related forms
The ZAZIBONA process is a collaboration between national medicines regulatory authorities (NMRAs) in Botswana, Namibia, Zambia, and Zimbabwe. These are four neighbouring countries in Southern Africa which have a combined population of around 34 million. This process may be extended to include participation by other interested SADC Member States.
The vision of the ZAZIBONA process is:
a region in which good-quality medicines are available to all those who need them;
significantly reduce time taken to grant marketing authorization (registration) in the individual countries; and
efficient utilisation of resources within regional national regulatory authorities through work sharing.
The process objective is to promote a collaboration model to facilitate access to good-quality medicines through worksharing in assessment of medicines and inspection of medicine manufacturing and testing facilities. Products that meet assessment criteria are then granted registration in the participating countries, in which CTD-format applications for registration would have been submitted. Where countries agree that is necessary, variations to the products which have been registered under this collaboration may be handled through the same process.
The ZAZIBONA collaboration does not represent the replacement of the need to submit applications for registration in participating countries in line with national requirements. However, as described in this document, in order to facilitate cooperation among ZAZIBONA authorities, certain modifications are expected. Although there is close collaboration on assessments and inspections, final national registration decisions are the responsibility of individual participating authorities.
It is envisaged that manufacturers of needed medicines will benefit from accelerated registration processes, a single set of questions during the registration process and in principle harmonized registration decisions, which will facilitate easier review of any post-registration variations. Applications may be submitted by any person that qualifies to be an applicant in each participating country as per national requirements.