China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2011, sales on the Chinese drug market have reached RMB 1550 billion (about US$246 billion), an increase of 7.08 fold over 2000 level. A series of factors, such as an increasingly ageing population, accelerating growth of urban population as well as expansion of healthcare covering urban and rural will grow the Chinese drug market with a growth rate over 25 percent per annum in next three years. China is expected to become the second largest drug market in the world by 2015.
Since the reform and open door policy implemented by Chinese authorities in the late 1970s, the door of the Chinese drug market began opening up to the world step by step, which not only gave a fillip to the imported drugs from overseas pharmaceutical manufacturers but also attracted overseas investors to establish the foreign investment enterprises, including “Sino-foreign equity joint ventures (EJV)”, “Sino—foreign cooperative joint ventures (CJV)” and “wholly foreign-owned enterprises (WFOE)” in China. Since the 1980s, thousands of foreign pharmaceutical companies have entered the Chinese drug market. Today, multinational pharmaceutical companies have over 1140 active joint ventures and foreign-owned enterprises in China and most giants of global pharmaceutical industry have a Chinese presence, including AstraZeneca, Pfizer, Roche, Novartis, Merck & Co, Eli Lilly & Company, GlaxoSmithKline and Johnson & Johnson. By 2011, sales of drugs manufactured and produced by the foreign-funded pharmaceutical manufacturers and producers in China have shared over one fourth on the Chinese drug market. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door to a lucrative drug market for foreign-funded pharmaceutical companies, and multinational pharmaceutical companies. More and more overseas pharmaceutical manufacturers and producers expect to enter such drug market and seize a larger part of such drug market.
To enter such a lucrative drug market, the overseas pharmaceutical manufacturers and producers must conform to Chinese Good Manufacturing Practice (GMP) regulations for pharmaceuticals. Therefore, a comprehensive and thorough knowledge of the latest Chinese Pharmaceutical GMP regulations has been become an essential prerequisite for overseas pharmaceutical manufacturers and producers to achieve a successful entry into the Chinese drug market, so more and more overseas pharmaceutical companies and multinational pharmaceutical companies, and their senior executive officers engaging in regulatory affairs expect to understand the latest Chinese Pharmaceutical GMP regulations.
The Chinese health authorities, the Ministry of Health (MOH) issued the latest Good Manufacturing Practice for Drugs (2010 Revision), which came into effect as of March 1, 2011, after five years of amendments and two rounds of public consultation. Since its first promulgation in 1988, Chinese Good Manufacturing Practice for Drugs (GMP) has experienced two amendments in 1992 and 1998 respectively. The latest version of GMP follows up the main principles of WHO GMP, adopting advanced international experiences and in light of the actual conditions of China. The latest version of GMP consists of 14 chapters and 313 articles. The Chinese pharmaceutical authorities, the Sate Food and Drug Administration (SFDA) issued five documents as annexes of the latest GMP, that is, Good Manufacturing Practice for Sterile Pharmaceutical Products, Good Manufacturing Practice for Active Pharmaceutical Ingredients, Good Manufacturing Practice for Biological Products, Good Manufacturing Practice for Blood Products, and Good Manufacturing Practice for Traditional Chinese Medicine Preparations, also came into effect as of the same time with the latest version of GMP.
For more information kindly visit :
Latest Guide to Chinese Pharmaceutical GMP Regulations
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