This publication examines the regulatory guidelines for registration and submission criteria in South Africa. South African Health Products Regulatory Authority (SAHPRA) is the entity of the national department of health (NDoH) launched in February 2017. It replaced the former Medicines Control Council (MCC) as well as Directorate of Radiation Control (DRC) that regulated medical devices in-vitro diagnostic tests and devices, radiation-emitting products and devices used in health care and industry.
Due to several drawbacks of MCC such as becoming dependent on external expertise, it eventually lead to lack of effective performance management contracts and unsustainable mechanism for submission of evaluation reports, SAHPRA is established. An application for registration of medicines should be submitted for evaluation and approval through SAHPRA guidelines which are applicable to human medicines including biological and complimentary medicines.
So SAHPRA adopted EU variation guidelines for quality and bio equivalence requirements for new registration and variations that are submitted by applicant in eCTD format established by the International Council for Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Submission of applications are done by following South Africa eCTD validation criteria in module 1 of regional information provided by South Africa.
Table of Contents
I. INTRODUCTION
II. GENERAL INFORMATION
III. EUROPEAN UNION VARIATION GUIDELINES
IV. REGISTRATION REQUIREMENTS
V. e-CTD VALIDATION CRITERIA
VI. SUBMISSION OF REGULATORY INFORMATION IN e-CTD FORMAT
VII. DOCUMENTATION
VIII. CONCLUSION
IX. BIBLIOGRAPHY
Objective and Core Topics
This publication outlines the regulatory framework, registration criteria, and submission procedures mandated by the South African Health Products Regulatory Authority (SAHPRA) for medical products. It serves as a comprehensive guide for applicants navigating the transition to electronic submissions, harmonized European Union guidelines, and procedural requirements for maintaining marketing authorizations in South Africa.
- Regulatory shifts from the Medicines Control Council (MCC) to SAHPRA and its impact.
- Guidelines for the registration of human medicines, including biological and complementary variants.
- Evaluation pathways, reliance mechanisms, and the classification of variations (Type IA, IB, and II).
- Detailed specifications for eCTD submissions, including validation criteria and naming conventions.
Excerpt from the Book
REGULATORY REVIEW PROCESS:
The registration of medicines in South Africa is governed by the provisions and requirements of the Medicines Act including the regulations and the published guidelines. Legislative frameworks require that medicines including New Chemical Entities, multisource/generic medicines, biological medicines, complementary medicines, and veterinary medicines are evaluated by the NRA before marketing the product. Applicants are required to submit technical dossiers to demonstrate the quality, safety, and efficacy of such medicines intended for sale in South Africa. The confidentiality of information submitted to the NRA is governed by Section 34 of the Medicines Act regarding the preservation of secrecy. The NRA made use of both internal and external expertise to evaluate applications for the registration of medicines. A full review of the safety, quality, and efficacy data, together with the assessment reports prepared by reviewers were considered by the various expert committees to make recommendations on the approval of the proprietary name of the product, the allocation of a scheduling status for the active pharmaceutical ingredient and the evaluation of the GMP status of the applicant, the manufacturer of the active pharmaceutical ingredient, the manufacturer of the finished pharmaceutical product, the packer and the quality control laboratory. The final decision for authorization or refusal was made by the MCC.
Summary of Chapters
I. INTRODUCTION: Provides an overview of the transition from the Medicines Control Council (MCC) to the South African Health Products Regulatory Authority (SAHPRA) and its regulatory mandate.
II. GENERAL INFORMATION: Outlines the scope of registration, applicant eligibility, language requirements, and the foundational rules for submitting medicine applications in South Africa.
III. EUROPEAN UNION VARIATION GUIDELINES: Details the classification system for variations, including administrative, quality, safety, and efficacy changes aligned with EU standards.
IV. REGISTRATION REQUIREMENTS: Covers specific exceptions and clarifications in the application process when adopting EU variation codes within the South African context.
V. e-CTD VALIDATION CRITERIA: Explains the technical requirements for electronic dossiers to ensure they pass automated checks and administrative compliance for SAHPRA.
VI. SUBMISSION OF REGULATORY INFORMATION IN e-CTD FORMAT: Guides applicants through the electronic submission process, including folder structures and the use of the eCTD backbone.
VII. DOCUMENTATION: Specifies the technical file requirements, including media types, PDF optimization, and naming conventions for diverse regulatory documents.
VIII. CONCLUSION: Reviews the progress made in clearing backlogs and outlines strategic initiatives for improving regulatory efficiency in South Africa.
IX. BIBLIOGRAPHY: Lists the regulatory acts, internal guide documents, and academic sources consulted for this work.
Keywords
SAHPRA, Medicines Act, Registration, eCTD, Variation Guidelines, Quality Assurance, Regulatory Review, Clinical Data, Pharmacovigilance, Marketing Authorization, Bioequivalence, Good Manufacturing Practice, Dossier Submission, Compliance, South Africa.
Frequently Asked Questions
What is the primary focus of this publication?
The work provides a detailed overview of the regulatory requirements overseen by SAHPRA, focusing specifically on how applicants should register new medicines and manage post-registration changes using modern submission formats.
What core regulatory themes are addressed?
Key themes include the legislative transition to SAHPRA, the adoption of EU-aligned variation and registration guidelines, and the establishment of rigorous technical standards for electronic dossiers.
What is the primary goal of the authority regarding these guidelines?
The overarching goal is to harmonize South African health product regulation with global best practices to ensure the quality, safety, and efficacy of medicines available in the country while improving approval efficiency.
Which scientific methods are central to this regulatory framework?
The framework relies on comprehensive dossier evaluations, including data on quality, non-clinical and clinical performance, comparative bioavailability/bioequivalence studies, and adherence to Good Manufacturing Practices (GMP).
What information is covered in the main section concerning submissions?
The main part of the text covers the technical architecture of eCTD submissions, including validation criteria, file naming conventions, folder structures, and the management of administrative documentation.
Which keywords characterize this document?
The work is characterized by terms such as SAHPRA, eCTD, Variation, Registration, Compliance, Pharmacovigilance, and Regulatory Review.
How does SAHPRA handle reliance on other regulatory bodies?
SAHPRA utilizes specific evaluation pathways (Abridged review, Verified review, and Recognition) to leverage the assessment efforts of Recognized Regulatory Authorities (RRAs), thereby reducing evaluation timelines.
What is a "baseline submission" in this context?
A baseline submission marks the transition of an existing product's data from a paper-based or old format into the new electronic eCTD format, serving as a solid foundation for future regulatory lifecycle management.
How are fees structured according to the latest guidance?
Fees are tiered based on the nature of the application, categorized into Type IA, Type IB, and Type II variations, with additional levels defined for major variations involving clinical or quality data complexity.
What specific advice is given for eCTD naming conventions?
Applicants are advised to strictly adhere to the ICH M2 eCTD Specification and the South African Specifics for Module 1, ensuring files are optimized for readability and searching.
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- Dr Shailaja Pashikanti (Autor:in), G. Snehalatha (Autor:in), N. S. R. L. Manimala (Autor:in), 2022, Regulatory Guidelines for Registration and Submission Criteria in South Africa (SAHPRA), München, GRIN Verlag, https://www.grin.com/document/1304787
