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.
Inhaltsverzeichnis (Table of Contents)
- INTRODUCTION
- GENERAL INFORMATION
- EUROPEAN UNION VARIATION GUIDELINES
- REGISTRATION REQUIREMENTS
- e-CTD VALIDATION CRITERIA
- SUBMISSION OF REGULATORY INFORMATION IN e-CTD FORMAT
- DOCUMENTATION
Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)
This document aims to provide comprehensive guidelines for the registration and submission of regulatory criteria in South Africa, as overseen by the South African Health Products Regulatory Authority (SAHPRA). It covers various aspects of the regulatory landscape, including general information, European Union variations, registration requirements, electronic Common Technical Document (e-CTD) validation criteria, and submission procedures.
- Regulatory framework for health products in South Africa
- Registration and submission processes for various health products
- Harmonization of regulatory requirements with international standards
- Implementation of electronic submission systems for regulatory data
- Quality assurance and control measures for health products
Zusammenfassung der Kapitel (Chapter Summaries)
- Introduction: This chapter provides an overview of the South African regulatory landscape for health products, highlighting the role of SAHPRA and its responsibilities in ensuring the safety, quality, and efficacy of these products. It also delves into the historical evolution of regulatory guidelines and the importance of international harmonization.
- General Information: This chapter covers essential aspects of the regulatory process, including definitions, scope, and application of various regulatory guidelines. It also outlines key principles and policies that underpin the regulatory framework for health products in South Africa.
- European Union Variation Guidelines: This chapter discusses the specific considerations and requirements for variations to existing registered health products, aligning them with European Union (EU) regulatory standards. It delves into the procedures for applying for variations and the documentation required for successful submission.
- Registration Requirements: This chapter comprehensively outlines the requirements for registering health products in South Africa. It covers aspects such as applications, documentation, and submission protocols, providing detailed guidance on the necessary steps for manufacturers seeking to register their products in the country.
- e-CTD Validation Criteria: This chapter focuses on the implementation of electronic Common Technical Documents (e-CTD) for regulatory submissions. It outlines the validation criteria for e-CTD submissions, ensuring compatibility and data integrity within the electronic system.
- Submission of Regulatory Information in e-CTD Format: This chapter delves into the practical aspects of submitting regulatory information in the e-CTD format. It covers various aspects, including document structure, formatting, and submission procedures. This chapter provides comprehensive guidance on ensuring the successful transmission and processing of regulatory information within the e-CTD system.
- Documentation: This chapter discusses the comprehensive documentation requirements for various aspects of the regulatory process. It covers areas like master files, manufacturing records, and quality control procedures, highlighting the importance of maintaining accurate and complete documentation for regulatory compliance.
Schlüsselwörter (Keywords)
Key terms and concepts prevalent in this document include: South African Health Products Regulatory Authority (SAHPRA), registration, submission, regulatory guidelines, European Union, variations, e-CTD, validation criteria, documentation, quality assurance, health products, manufacturing, good manufacturing practices (GMP), and international harmonization.
- Citar trabajo
- Dr Shailaja Pashikanti (Autor), G. Snehalatha (Autor), N. S. R. L. Manimala (Autor), 2022, Regulatory Guidelines for Registration and Submission Criteria in South Africa (SAHPRA), Múnich, GRIN Verlag, https://www.grin.com/document/1304787
