About the Course Mentorship Initiative Programme course 

Course Duration: 1–2 weeks (20–30 hours)
Delivery Mode: Hybrid (face-to-face & e-learning via Moodle/SCORM)
Target Participants: Herbalists, Herbal Therapists, Naturopathic Doctors, Herbal Technologists, Small-Scale Herbal Manufacturers, and Researchers in Herbal/Phytomedicine.

1.Course Introduction

Herbal medicines play a significant role in Zambia’s healthcare system, especially within communities where traditional and naturopathic practices are widely embraced. However, for herbal products to be legally registered, marketed, or exported, they must undergo a structured regulatory approval process. Central to this process is the preparation and submission of a dossier—a comprehensive collection of scientific and regulatory documents that demonstrate a product’s quality, safety, and efficacy. This short course provides awareness, practical knowledge, and hands-on skills in dossier compilation for herbal medicine registration. While not replacing official regulatory guidance, the course is aligned with the requirements of the Zambia Medicines Regulatory Authority (ZAMRA) and international standards.

2. Aim 

To empower herbal medicine practitioners, innovators, and researchers with the knowledge and skills needed to develop, compile, and present professional dossiers that meet national and international regulatory requirements.

3. Course Objectives 

By the end of this course, participants should be able to:

1. Describe the national and international regulatory frameworks governing herbal medicine.
2. Identify and interpret dossier requirements for herbal product registration.
3. Apply quality assurance principles in herbal medicine documentation.
4. Demonstrate competence in preparing evidence for safety and efficacy of herbal formulations.
5. Compile a professional mock dossier aligned with ZAMRA standards.

4. Core Competencies 

Participants will develop competencies in:

• Understanding herbal medicine regulatory pathways.
• Evidence-based dossier preparation and submission.
• Application of Good Manufacturing Practice (GMP) principles.
• Quality control, safety evaluation, and pharmacovigilance.
• Professional documentation and compliance with regulatory standards.

5. Course Content

Unit 1: Regulatory Framework for Herbal Medicines in Zambia (3 hours)

• Overview of the Medicines and Allied Substances Act (No. 3 of 2013).
• ZAMRA’s role in herbal product regulation.
• Registration categories: Traditional use vs. Scientific evidence-based.
• Regional (SADC, AU) and global (WHO) guidelines.

Unit 2: Structure and Requirements of a Herbal Medicine Dossier (5 hours)

• Definition and purpose of a dossier in regulatory science.
• Core dossier modules: Administrative, Quality, Safety, Efficacy.
• Differences between traditional knowledge dossiers and scientific dossiers.
• Review of dossier templates in Zambia and internationally.

Unit 3: Quality Standards and Documentation (5 hours)

• Botanical authentication and herbarium references.
• Manufacturing process flow and GMP documentation.
• Stability testing and shelf-life data.
• Packaging, labeling, and batch records.

Unit 4: Safety and Efficacy Evaluation (5 hours)

• Toxicological assessment (acute, sub-acute, chronic).
• Evidence sources: literature, ethnopharmacology, preclinical, and clinical studies.
• Recording adverse events and pharmacovigilance.
• When to escalate to clinical trial evidence.

Unit 5: Practical Guide to Dossier Compilation (6 hours)

• Module 1: Administrative information & product details.
• Module 2: Quality documentation.
• Module 3: Safety data.
• Module 4: Efficacy evidence.
• Mock dossier preparation – step-by-step.

Unit 6: Workshop & Case Studies (6 hours)

• Group exercise: Compiling a dossier for a selected herbal product.
• Peer review of dossiers.
• Expert panel feedback (regulatory officers, Pharmacologists, Clinical Scientists).

6: Teaching Methods

• Interactive lectures (in-person & online).
• Case studies and practical dossier development.
• Group discussions and peer learning.
• Guest sessions by experts.

7: Assessment 

• Class participation (10%).
• Group dossier compilation exercise (40%).
• Final dossier submission and presentation (50%).

8: Certification

Participants who successfully complete the course and submit a dossier will receive a:
Certificate of Attendance in Herbal Medicine Dossier Preparation.

If you're interested in the Mentorship Initiative Programme,kindly join

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