The draft Blood and Blood Components Regulations are now available
Download the regulations using the following link
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 or
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.
The Quality Policy of the Medicines Control Authority of Zimbabwe (MCAZ) is to ensure the provision of accurate and timeous services, continuously meet requirements of our customers and guarantee patient safety as stated in the Medicines and Allied Substances Control Act (Chapter 15:03). This enables the Authority to be an effective medicines regulator in Zimbabwe and a leading regulatory authority in the world. MCAZ is committed to protecting the public and animal health by ensuring that accessible medicines, allied substances and medical devices are safe, effective and of good quality. This is achieved by carrying out activities in accordance with the relevant procedures and specifications.