Southern African Development Community (SADC), as a region has harmonized medicines registration guidelines in the common technical document (CTD) format that were approved in January 2015. Nevertheless, the harmonization of product information and labelling requirements within the region has been outstanding. Harmonizing regulatory standards to create one regional market and mutual recognition is one of the strategies included in the draft Strategy on Regional Manufacturing of Essential Medicines and Health Commodities (2016-2020), which supports the pharmaceutical component in the SADC Industrialization Strategy and Roadmap 2015 – 2063. Moreover, this supports the priority areas of creating an enabling regulatory environment and strengthening medicines regulatory capacity in the approved SADC Pharmaceutical Business Plan 2015 – 2019.
Taking into account the need for stakeholder engagement in drafting regulatory guidelines, a workshop with industry and regulators was held as the initial step in developing a regional guideline on product information and labelling. This engagement resulted in drafting instructions for the product information and labelling guideline that were approved by the regulators forum. Subsequently, these drafting instructions were utilized for formulating the guidelines presented in this document. Please Click the following links to download the Guidelines and Table for Comments.
SADC GUIDELINE ON PRODUCT INFORMATION AND LABELING
SADC GUIDELINE ON PRODUCT INFORMATION AND LABELING: TABLE FOR COMMENTS
Guidance on submission of covid-19 vaccine applications for emergency use authorisation and registration have been published. Click MCAZ COVID-19 VACCINE GUIDANCE-VERSION 11 download the guideline.
In order to improve service delivery to our valued customers, MCAZ collects information on Customer Complaints. To download the 2019 Customer Complaints Trends Analysis Click here
The Medicines Control Authority of Zimbabwe (MCAZ) Covid-19 Health and Safety Guidelines applies to MCAZ staff with the intention of preventing workplace infections, protecting lives, and promoting employee health for...
The draft Blood and Blood Components Regulations are now available Please note that this is a DRAFT that has been uploaded to obtain comments from stakeholders before the regulations are...
This Medical Product Alert warns consumers, healthcare professionals, and health authorities against a growing number of falsified medical products that claim to prevent, detect, treat orcure COVID-19. Medical...
Draft SADC Variations Guidelines are now available Click the following links to download the guidelines and the comments sheet Draft SADC Variations Guidelines Draft SADC Variations Guidelines Comments Sheet
In pursuit of promoting high ethical standards, the Authority has formulated a Code of Ethics for its employees and members of the Authority .The Authority believes that high ethical...
Southern African Development Community (SADC), as a region has harmonized medicines registration guidelines in the common technical document (CTD) format that were approved in January 2015. Nevertheless, the harmonization...