Adverse Drug Reactions to Human Medicines in South Africa

South Africa – POST-MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA The South African MCC (Medicines Control Council) has issued a revised version of the guideline (November 2016) covering Post-Marketing Safety Reporting, which was implemented in September 2016, the update clarifies that: the requirements do not apply to unregistered medicines the applicant needs to specify and communicate to the authorities the 12-month period he decides to use for the Summary Evaluation Statement, which must be submitted within 90 days of the Data Lock Point The guideline can be located at: http://www.mccza.com/Publications/Index/1

International Committee on Harmonisation

International Committee on Harmonisation (ICH) meeting 5th – 10th November 2016 ICH E6 (R2) update agreed and preparations in place for effective date of 14th June 2017. “Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities. When the original ICH E6(R1) text was prepared, clinical trials were performed in a largely paper-based process. Advances in use of electronic data recording and reporting facilitate implementation of other approaches. For example, centralized monitoring can now offer a greater advantage, to a broader range of trials than is suggested in the original text. Therefore, this guideline has bee

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