China’s Ministry of Health has published the country’s first-ever guidance for doctors on the use of medicines.

The document provides advice on the correct use of a range of widely-prescribed medicines, including all those listed on the National Basic Medicine Catalogue and the Catalogue of Drugs for Basic National Medical Insurance, but its use will not be mandatory, according to Ministry officials.

The list has been compiled by more than 100 Chinese and international pharmaceutical experts over a two-year period. Their final guidance borrows from the experiences of developed nations and the World Health Organisation (WHO) but also takes account of established clinical practice in China, according to Cao Guirong, president of the Chinese Hospital Association.

Meantime, China’s pharmaceutical market is expected grow an average 12.5% each year to 2014, by which time it will be worth “a staggering” $92.2 billion, according to new forecasts from market research firm Business Monitor International (BMI).

The market has been hardly affected by the global economic downturn, and its fast growth will be driven by the government’s $124 billion health care reform programme, the increasing incidence of western diseases, fast-rising population numbers, economic growth and moves to encourage foreign investment, BMI reports.

Overseas drugmakers have also benefited from the State Food and Drug Administration (SFDA)’s introduction, in January 2009, of the Green Channel expedited drug approval process. This has allowed products such as Dacogen (decitabine), a novel treatment for myelodysplastic syndrome produced by Johnson & Johnson’s Xian-Janssen unit, to be marketed in China based on clinical trials conducted overseas because the condition represents an unmet medical need in the country and the patient population there is small.

However, foreign drugmakers still face major problems in China, including “rampant” piracy, substandard quality, bureaucracy and a poor legal framework, says BMI.

Moreover, while the number of traditional Chinese medicines (TCM) on the latest Essential Drugs List (NEDL), published last August, has been increased to 102, the 205 chemical and biological drugs listed are mainly generics.

The state reimburses patients fully for all products on the NEDL, which are used in the treatment of up to 80% of China’s most common diseases and are required, by Ministerial decree, to be available to doctors and stocked by pharmacists and county hospitals. However, the BMI points out that, despite the country’s significant infectious disease burden, the current List includes no vaccines, atypical antipsychotics, biological or antiseptic products.

The NEDL will be updated again in three years time, in line with economic development trends, disease profiles and the progression of science, and the government is forecasting its universal uptake by all state facilities by 2020, the report notes.