China’s SFDA starts overseas inspections
pharmafile | November 15, 2011 | News story | Manufacturing and Production |Â Â China, SFDA, manufacturing and productionÂ
China’s State Food and Drug Administration (SFDA) has started to inspect overseas manufacturing facilities in yet another sign of the agency’s efforts to bring its practices in line with international standards.
The move is increasingly important given the burgeoning growth in the domestic Chinese pharmaceutical market, which is tipped to increase from $40 billion at present to $100 billion in 2015 and $200 billion in 2020, at which point it will become the largest drug market in the world.
At the same time, the proportion of imported medicines is also expected to increase, from a current level of around 20%, with domestic producers currently meeting around 50% of demand and joint ventures with foreign drugmakers another 30%.
The start-up of overseas inspections – the first block are due to be carried out this month – comes on the tail of a dramatic revision of China’s regulations on Good Manufacturing Practice (GMP), which became effective on March 1, 2011 and are due to be universally adhered to in 2015.
New pharmaceutical facilities have had to require with the new GMPs from 1 March of this year, with sterile product manufacturers having a compliance deadline of 31 December, 2013. All other organisations must be in adherence by December 31, 2015.
Part of that effort has included a revision of its inspection practices, with a shift towards standardised practices, certification procedures and new approaches to the recruitment, training and evaluation of its inspection teams.
The overall aim was to bring GMP in line with other developed countries with the introduction of concepts accepted elsewhere, such as the pivotal role of the qualified person (QP) within an organisation’s quality department and the use of a risk-management approach in inspections, rather than the old ‘checklist’ system.
The SFDA says 5 to 10 overseas site visits are due to take place over the coming weeks in five countries, with many of the companies involved volunteering for inspection in order to help the agency refine and improve its procedures.
Phil Taylor
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