PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Tuesday, 16 July 2019

 

SADC Guidelines Picture.

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

MCAZ Draft Variation Guidelines.

In line with the WHO guidelines on variations and other SRA guidelines, the EVR Division is updating the MCAZ Guidelines for submitting applications for Variations to Registered Medicines.
The update is to ensure; inclusion of the classification of additional post-registration changes and to establish the level of risk inherent to each change, definition of timelines for different types of variations, alignment of variation submissions with the CTD format, inclusion of requirements for variations for sterile and biological products and inclusion of requirements and timelines for SRA and WHO PQ approved products variations.
Applicants should make use of the attached template EVR form 38 i.e. Comments to draft Guidelines for submitting applications for Variations to Registered Medicines. The duly completed form should be emailed to This email address is being protected from spambots. You need JavaScript enabled to view it. by no later than 15 July 2019.
 
 

 

 

 

Background  

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.

 

Click to download Brochure for Fellowship in regulatory science for African Medicine Reviewers/Assessors (2019)

 

 

 

 

 

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

  • Part III or Part IV University of Zimbabwe / Harare Institute of Technology Bachelor of Pharmacy (Hons) degree students in academic year 2019/2020
  • Good passes in previous examinations of the degree programme
  • Willing to work for MCAZ on completion of the degree programme

 

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

 

Latest News

SADC Guideline on Product Information and Labeling

10 July 2019
SADC Guideline on Product Information and Labeling

  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...

Draft Guidelines For Comments Only: Guideline for Submitting Application for Variations to Registered Medicines

17 May 2019
Draft Guidelines For Comments Only: Guideline for Submitting Application for Variations to Registered Medicines

In line with the WHO guidelines on variations and other SRA guidelines, the EVR Division is updating the MCAZ Guidelines for submitting applications for Variations to Registered Medicines. The update...

Careers @ MCAZ

30 October 2018

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 Part III or Part IV University...

Fellowship in regulatory science for African Medicine Reviewers/Assessors

26 October 2018
Fellowship in regulatory science for African Medicine Reviewers/Assessors

  Background   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...

Quality Policy Statement

06 July 2018
Quality Policy Statement

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...

MCAZ Newsletter

10 May 2018
MCAZ Newsletter

In this issue: MCAZ turns 20 years Basics of reporting Side Effects of medicines Electronic Adverse Drug Reaction Reporting   For more information Please click here to download the Newsletter...

Medicines Information Bulletin

02 February 2018
Medicines Information Bulletin

Increased Reporting from the Targeted Spontaneous Reporting (TSR) Programme Click here to download Drug Information Bulletin    

Press Statement on extension of submission of Complementary medicines applications

18 May 2017
Press Statement on extension of submission of Complementary medicines applications

Download Complementary  medicines applications extension - press statement

Zimbabwe National Pharmacovigilance Policy Handbook

12 April 2017
Zimbabwe National Pharmacovigilance Policy Handbook

The aims of the PV policy handbook are to firstly provide a framework for a national pharmacovigilance system in Zimbabwe. Secondly, to define the pharmacovigilance activities undertaken by the Pharmacovigilance...

Scholarship Programme Publicity

14 July 2016
 Scholarship Programme Publicity

The Medicines Control Authority of Zimbabwe (MCAZ) as a responsible corporate citizen runs a Scholarship Fund as part of its corporate social responsibility programmes.   Click here to download the...

Guidelines for Advertising and Promotion of Medicines

24 June 2016
Guidelines for Advertising and Promotion of Medicines

  The approved Guidelines for Advertising and Promotion of Medicines are now available.  Download the Guidelines for Advertising and Promotion of Medicines  

Complementary Medicine Regulation

19 April 2016
Complementary Medicine Regulation

The Medicines Control Authority of Zimbabwe is responsible for the evaluation of safety, efficacy and quality and registration of complementary medicines destined for use in Zimbabwe. Please see the documents...

SADCAS Accreditation for Chemistry and Medical Devices Laboratories.

06 January 2016
SADCAS Accreditation for Chemistry and Medical Devices Laboratories.

The MCAZ Chemistry and Medical Devices laboratories are now accredited to the ISO/IEC 17025 standard through the Southern African Development Community Accreditation Service (SADCAS). The Chemistry laboratory is accredited for...

ZAZIBONA Collaborative Medicines Registration Process

06 January 2016
ZAZIBONA Collaborative Medicines Registration Process

  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...