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Post-Marketing Reporting of Adverse Drug Reactions to Human Medicines in South Africa  

MedicinesBiologicalsHerbal Cosmetic Nutra | South Africa

Every applicant is required to report ADRs known to them involving their marketed medicines in accordance with the requirements of Act 101 of 1965 Regulation 40. The success of the Authority’s ADR reporting system depends on the quality, completeness, and accuracy of the information submitted. Reporting of ADRs and monitoring thereof, remain a viable means of identifying previously unrecognized, rare, or serious ADRs.

This guideline describes the following points;

  • Pharmacovigilance Obligations of The Holder Of A Certificate Of Registration/ Applicant
  • Adverse Drug Reaction Reports
  • Procedures for Reporting
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Access to Unregistered Medicines – South Africa  

Medicines | South Africa

SAHPRA is mandated to regulate the safety, efficacy, and quality of all medicines. Prior to registration
of a medicine, access is usually limited to clinical trials authorized by the Authority. SAHPRA may,
in certain circumstances, and in accordance with Section 21 of the Act, authorize the sale of an
unregistered medicine for such purposes and in such manner and during such period as the
Authority may determine.

This guideline describes the following points;

  • Possible Access Scenarios
  • Roles and Responsibilities
  • Application Process
  • Evaluation Process
  • Record Keeping
  • Reporting

 

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Guideline for The API Master File (APIMF) Procedure  

Medicines | South Africa

An Active Pharmaceutical Ingredient Master File (APIMF) contains all the required information for the quality
evaluation of an API. The APIMF is comprised of two parts:

  • The open part: The applicant must have access to this information, and it must be sufficient for the
    applicant to ensure the suitability of the API used in the finished pharmaceutical product (FPP)
  • The closed part: The applicant does not have always access to this information, which is
    the confidential intellectual property of the API manufacturer, including a detailed description of the
    the manufacturing process (with individual steps ), manufacturing quality control procedures, process
    validation etc.

The objectives of the APIMF Procedure are as follows:

  • To ensure that the API manufacturer’s proprietary information is managed confidentially end-to-end
  • To allow one evaluation of an API from a specific manufacturing site to be used across multiple
    finished pharmaceutical product (FPP) evaluations, reducing quality evaluation timelines.
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Interim Variations Addendum for Human and Veterinary Medicines  

Medicines | South Africa

The South African Health Products Regulatory Authority (SAHPRA) has decided to harmonize certainly
SAHPRA human medicine policies and procedures with those of the European Medicines Agency
(EMA). These, in turn, are aligned to the framework of the International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use (ICH), as well as the International
Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal
Products (VICH).

This article describes the following points;

  • Implementation
  • Definitions
  • Exceptions to the EU variation classification guidelines
  • Fees

 

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Guidance for The Submission of The South African CTD /eCTD – General & Module 1  

Medicines | South Africa

The document describes how to organize applications based on the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on the CTD. The CTD is currently only applicable to human, not veterinary, medicines.

This guideline describes the following points;

  • Module 1 – Administrative information and prescribing information
  • Module 2 – Summary of the dossier
  • Module 3 – Quality
  • Module 4 – Non-clinical study reports
  • Module 5 – Clinical study reports
  • European Union guidelines on quality, safety, and efficacy
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JORDAN Module 1 eCTD Specification Release Notes  

Medicines | Jordan

This document lists and briefly describes the updates and fixed issues included in the release of
the Jordan Module 1 eCTD Specification version 1.1 compared to version. 1.0.2.

This article describes the following points;

  1. Editorial Changes
  2. Changes in Envelope Data
  3. Changes in Submission Type
  4. Change of Sections Titles
  5. Change in Directories

 

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Frequently Asked Questions  

Medicines | Jordan

Prior to scheduling a submission appointment, all applicants should go through the
Frequently Asked Questions mentioned below:

  • What is an Application number?
  • When is the Application Number issued?
  • Where is the Application number reflected in an eCTD submission?
  • Where is “number” reflected in eCTD submission?
  • What is the UUID? etc.
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