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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Convergence 2020 has come and gone, but you can still access recorded sessions, which are available to attendees until 31 December 2020.
This year, our European regulatory community will converge online with a fully virtual program that will allow attendees to experience Euro Convergence live online from the safety and comfort of their homes.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
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Posted 04 February 2013 | By Ansis Helmanis,
China's State Food and Drug Administration (SFDA) issued a Notice on 29 January 2013 to provinces, municipalities and ports concerning the implementation of the national electronic monitoring system for imported pharmaceuticals, which will require foreign-based companies to have a local designate.
Foreign companies must designate a local Chinese pharmaceutical company, pharmaceutical wholesaler, subsidiaries or offices as their electronic monitoring agent in China. The local agent will be responsible for complying with the electronic monitoring requirements for the foreign company's imported drugs, and reporting to SFDA.
The requirement will take effect as of 31 December 2013. The notice includes links to the following registration forms:
Read all Breaking News from RegLink
Tags: SFDA
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