QC: Key to the World Market

In the world, rights to life and health have been respected so much that they have been brought to an unprecedented height. In June, the bill of REACH (Bill of Registration, Evaluation and Admission on Chemical Products) in European Union became effective formally. Recently, the FDA (Food and Drug Administration) in America has also strengthened its administrative measures for food imported from China and drugs produced in China. All these facts indicate that the globalization strategies of the domestic medical enterprises are facing more and more serious challenges.

For the domestic medical enterprise, the globalization of medicine challenges not only the enterprise’s strength, but also its quality control system. At present, the domestic medical industries, led by the Yangtze River Pharmaceutical Group（hereinafter referred to as YRPG）, have adjusted their operation strategies to meet the requirements of the world market, which will in turn spur the domestic medical enterprises to harmonize its medicine quality control system with the international standards. Xu Jingren, the board chairman of YRPG, believes that high quality is ensured by the procedure of production instead of investigation. The implementation of the globalization strategies calls for not only the strengthening of the quality control and supervision by the Medicine Supervision Department, but also the self-discipline of the medical enterprises, which requests that these enterprises should make products according to the international standards. The enterprise itself should strengthen its sense of law, especially for those enterprises engaging in high-risk medicines. The enterprise should strictly control its medical materials and production procedure, and shoulder the responsibility for ensuring the safety of its medicines. 

Happiness and Sadness Involved in Domestic Medicine Quality Control

The QC (Quality Control) activities and its achievement, known as the most authoritative QC platform for domestic medical enterprises, have been regarded as the barometer of the QC level in domestic medical enterprises. It fully manifests the quality control level in the procedure of medicine production. The statistics offered by the China Quality Association for Pharmaceuticals shows that the number of the QC groups has been increased from 111 of last year to nearly 200, and the QC groups have expanded their activities from 11 provinces of last year to 16, reaching the highest level in history. The sense of QC among the domestic medical enterprises, especially in the case of YRPG, has been strengthened rapidly. However, the current situation of the domestic QC is far from optimistic. Although the QC activities have been carried out in the field of medicine production for nearly 30 years, the enterprises engaging in QC activities only account for 5% of the existing 5000 medical enterprises. These facts indicate that small and medium-sized enterprises are not serious enough in terms of QC, which certainly will in turn restrict the globalization of the domestic medical enterprises.   

Quality Control Being the Watershed, and Large Enterprises Can Conquer and Rule Finally in the Field of Medicine Industry

Our country has adjusted its import and export regulations on some sensitive industries under the wide international influence. At present, our country is making some new foreign trade qualification standards on medicines and foods. Xu Jingren believes that large medical enterprises have absolute superiority over its quality control. These adjustments will no doubt influence the export pattern of the medical industries and speed up both the international and the domestic medicine resources to flow into the large enterprises. 

On 20^th July, the names of enterprises winning the “2007 Domestic Medicine QC Group Achievement Awards” were announced. YRPG won 20 awards altogether which account for 1/3 of the total awards, making a new record in the history of QC achievement in domestic medical enterprises. YRPG has won the first award of QC achievement for five years on succession. Large medical enterprises could enter the international market very easily with their superiority over quality control. Many core products made by YRPG meet the pharmacopoeia standard of America, European Union, England, and Japan. In 2005, YRPG took the lead in selling medicines worth 50,000 million Yuan, and its comprehensive economic benefits obtained has been the greatest of all the domestic medical enterprises.