加入PIC/S与推动我国参与GMP国际互认

China's Entering into PIC/S and Participating in GMP Mutual Recognition Agreements

目的:为我国加入药品检查协定和药品监察检查合作计划(PIC/S)提出对策。方法:结合PIC/S工作机制,分析加入PIC/S对我国参与GMP国际互认的意义,并就我国加入PIC/S的切入点进行分析和研究。结果与结论:加入PIC/S是可行的,此举对于我国GMP与有关国家互认和我国医药行业加速进入国际市场有非常重要的意义。

OBJECTIVE： To put forward strategies for China＇ s entering into PIC/ S. METHODS： Based on working mechanism of PIC/S, the importance of China＇s entering into PIC/S to China＇s participation in GMP Mutual Recognition Agreements （MRAs） and the hit point of China＇s entering into PICS were analyzed. RESULT ＆ CONCLUSION： Entering into PIC/S is feasible, as it is of significant importance for China＇ s GMP MARs with the related countries and the acceleration of China＇s pharmaceutical industry entering into the international market.