Thursday, 13 August 2020
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 finalised. Kindly submit your comments to This email address is being protected from spambots. You need JavaScript enabled to view it. on or before Monday the 26th of July, 2020.
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
cure COVID-19.
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 standards are essential in enhancing corporate performance and accountability ,ensuring transparency and protecting stakeholders’ interests at all times.
To download the Code of Ethics click here.
Draft SADC Variations Guidelines are now available
Click the following links to download the guidelines and the comments sheet
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
