Tuesday, 16 July 2019
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
The Medicines Control Authority of Zimbabwe (MCAZ) Regional Centre of Regulatory Excellence
(ReCORE) in partnership with the European and Developing Countries Clinical Trials Partnership
(EDCTP) is offering a 2-year fellowship in regulatory science to 8 – 10 assessors working in African medicines regulatory authorities (MRA). Fellows will be admitted in two groups, the first in 2019 and the second group in 2020. The MCAZ is a leading regulator on the African continent and has trained regulators from all over the continent for many years.
The fellowship will involve completion of short courses through block release training at the MCAZ / University of Zimbabwe (UZ), completion of the summer course and winter mini-conference at the Utrecht-WHO Collaborating Centre for Pharmaceutical Policy and Regulation in the Netherlands, practical work assignments, case studies, specific hours of practice (dossier assessments) over the fellowship period and a capstone project. The capstone project should be in the area of specialisation selected by the fellow and address a specific problem, issue or research question in regulatory science. Funding will be provided for 8 fellows and 2 additional fellows will be accepted provided they can fund themselves. The approximate cost of the fellowship is US$28 950 for the entire fellowship period.
SCHOLARSHIP OPPORTUNITIES
The Medicines Control Authority of Zimbabwe (MCAZ) is inviting applications from hard-working, well-disciplined, honest and self-motivated students for a scholarship opportunity.
Eligibility
The MCAZ is an equal opportunity employer. Female students are encouraged to apply.
Applicants should send their curriculum vitae, certified copies of qualifications and statements of intent to:
The Director-General
Medicines Control Authority of Zimbabwe
106 Baines Avenue/ Cnr. Third Street
P O Box 10559
HARARE
Closing Date is 31st May, 2019
Protecting your Right to Quality Medicines and Medical Devices
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.
Click here to view Quality Policy Statement
