PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Wednesday, 30 September 2020

PURPOSE

The Clinical Trial Unit of the Pharmacovigilance and Clinical Trials Division of the Medicines Control Authority of Zimbabwe (MCAZ) has a regulatory oversight function for clinical trials conducted in Zimbabwe.  All clinical trials of medicines in Zimbabwe involving human participants  must not be initiated until the MCAZ has, with the approval of the Secretary for Health and Child Welfare, authorised the conduct of the trial. The Clinical Trial unit receives, processes and evaluates the applications from local applicants (industry, academia and investigators) for approval to conduct the study within Zimbabwe. The unit also provides for authorization for the importation of unregistered medicine for the purpose of conducting clinical trials. Any amendments required during the conduct of the study, must be approved by MCAZ.

LEGISLATIVE FRAMEWORK

The Medicines and Allied Substances Control Act (MASCA) [Chapter 15:03] and Statutory Instrument 150 of 1991 provides for the legislative framework for the conduct and regulation of Clinical Trials. The Good Clinical Practice Guidelines along with its supporting documents provide researchers and other interested parties with clearly articulated standards of GCP in locally conducted research that address the local realities and contexts, to ensure that clinical trials involving Zimbabwean human participants are designed and conducted according to local requirements as well as according to the sound scientific and ethical standards within the accepted framework for good clinical practice. MCAZ has developed several guidelines for researchers in order to ensure that human participants are protected and are able to derive benefits from participating in clinical trials conducted in Zimbabwe

Download MASCA here

Download SI 150 of 1991 here

PROCESSING CLINICAL TRIALS APPLICATIONS

Researchers must submit a completed application online. Applications must be accompanied by the prescribed fee.

Clinical Trials Process Flow.

GUIDELINES FOR CLINICAL TRIALS

  1. Guidelines for Good Clinical Practice in Zimbabwe
  2. Clinical Trial Application Guidelines
  3. Pharmacy Guidelines for Investigational Products
  4. GCP Inspection Guide
  5. e-CTR System For The Medicines Control Authority Of Zimbabwe External User Manual
  6. Pharmacovigilance Electronic Reporting System User Manual

FORMS FOR CLINICAL TRIALS

Please note that following forms are required to be completed and submitted as part of the Clinical Trial Application:

  1. Clinical Trial application form MC10 also available on the MCAZ e-CTR Online System
  2. Checklist for Completeness Of An Application To Conduct A Clinical Trial
  3. Submission Declaration by Applicant
  4. Recommended Format for CV’s Of Individuals Participating In Clinical Trials
  5. Joint Declaration By Sponsor And Principal Investigator Concerning Sufficient Funds To Complete Study
  6. Declaration by Principal Investigator for GCP Compliance
  7. Declaration by Co- And Sub-Investigators for GCP Compliance
  8. Indemnity Form

Please note the forms that are required for use during the conducting of all Clinical Trials:

  1. Application for Clinical Trial Protocol Amendment
  2. Application for Additional Investigator(s), Change Of Investigator(s) or Additional Clinical Trial Sites
  3. Clinical Trial Annual Progress Reporting Form
  4. Joint MCAZ/MRCZ SAE Reporting Form also available on the MCAZ Electronic Reporting Online System
  5. Protocol Deviation Reporting Form

TRAININGS

This Medicines Control Authority of Zimbabwe was designated by the New Partnership for African Development (NEPAD) and the African Regulatory Harmonization (AMRH) as a Regional Centre of Regulatory Excellence (RCORE) in Clinical Trials and as such provides capacity building in Clinical Trials Regulatory Oversight. Download RCORE Brochure here

Scope of the training: The Clinical trial training is structured based on current local and international clinical trials regulation requirements including the and European Medicines Agency (EMA) basic guides on quality, efficacy and safety and pre-clinical studies. This also includes World Health Organisation (WHO)African Vaccine Regulatory Forum (AVAREF), Ethics, Nuremberg Code and Declaration of Helsinki. The course is conducted in collaboration with the Medical Research Council of Zimbabwe (MRCZ), Clinical Pharmacology Department University of Zimbabwe Medical School and School of Pharmacy, University of Zimbabwe, experienced academic lecturers, senior regulatory officers and GCP inspectors.

Aim: The aim of the training is to give participants the basic knowledge and skill to set up and run a clinical trials regulation department that competently evaluates clinical trial protocols, conducts GCP inspections, monitors ongoing clinical trials and runs efficient Pharmacovigilance systems.

The training will cover:

  1. Medicinal product development pre-clinical, quality, efficacy & safety, ICH-GCP and WHO Global Bench Marking Tool (GBT) Regulation Evaluation of National Regulatory System of Medicinal products - Clinical Trials Oversight (CT) indicators.
  2. Clinical Trial Protocol Evaluation
  3. GCP inspection and Report writing
  4. Adverse Events and Safety Monitoring (Pharmacovigilance)

The Clinical Trials Training program includes practical hands on training on how to evaluate a clinical trial protocol and how to conduct a GCP inspection. The same protocol used for the Protocol evaluation module will also be used for a practical GCP inspection training to be conducted in Harare, Zimbabwe.

OTHER CLINICAL TRIALS REGULATION WEBSITES OF INTEREST

 

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