Category Archives: News & Updates

Templates for Authoring Regulatory Documents in Africa

 

MRA has created CTD document templates and their links to guidance documents to assist you in writing your regulatory documents. These templates will ensure consistency in presentation of documents and support the author in finding the relevant current guidance documents to consider and refer to when writing the content thereof.

Contact: info@mra-regulatory.com 

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Other News 24 February 2017 Call-in for all businesses involved in the sale and distribution of Medical Devices and IVDs to license within a certain period: Manufacturers and Distributors – within 6 months Wholesalers – within 12 months Call-up Notice R 204, Gazette 23128 of 22.02.2002 rescinded. This call-up addressed the submission of abbreviated regulatory information… Continue Reading

eCTD News The eCTD has gone live as a submission format for all new applications for registration. The Implementation Guidance of the South African eCTD specification v2.1 and the related Validation Criteria v2.0 was published on the MCC website and updated in November 2016. Continue Reading

Changes to Regulations to the Medicines and Related Substances Act Draft General Medicine Regulations were published for comment on 27 January 2017. The comment period (3 months) closes on 26 April 2017. Follow the link to view the regulations: 2017-01-27_GG40577_MedicinesAct_Draft_GeneralMedicineRregulations Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs) were published on 9… Continue Reading

Training Offered We provide project based mentoring for regulatory departments and bespoke training for your regulatory affairs team. Training in compliance requirements related to Good Practice expectations for healthcare products is also offered for: Company Executives & Board Members Pharmacovigilance Officers GxP for Applicants / Holders of Certificates of Registration Regulatory Documents | Authoring & Editing… Continue Reading

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