Saturday, 17 November 2012

China FDA to reform medicines regulatory standards


China is expected to issue its first set of regulatory standards for companies developing biosimilars, industry experts told the FT. The country is gradually moving its pharmaceutical regulations closer to international standards, with the aim to speed up drug registration, the experts added. Biosimilars, or follow-on biologics, are drugs deemed to be similar to an originator biologic therapy. Biologic drugs are made in living organisms or their products, as opposed to traditional pharmaceutical drugs, which are made through chemical processes.The China State Food and Drug Administration (SFDA) will release a new Drug Registration Regulation after the 18th National Congress of the Communist Party, said Haifeng Hu, vice president, Shanghai Institute of Pharmaceutical Industry. The 18th National Congress took place in Beijing 8-14 November.Details of the biosimilars guidelines are currently undergoing investigation but will be finalized after the new drug registration regulation release, Hu noted.In China, the healthcare reform and critical illness insurance program issued this year will bring growing demand for biologics, especially for oncology drugs. Monoclonal antibodies (mAbs) are expected to be at the forefront, said Jianhoung Tao, vice president, Southern Medicine Economic Research Institute (SMEI) of SFDA.


Read more: FT/BioPharm Insight

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