Regulatory Cooperation Agreement Signed Between China SFDA and Hong Kong DOH

The Chinese SFDA and the DOH of Hong Kong signed an agreement that details future cooperation and communication with regards to medical device and pharmaceutical regulations. The Director of the DOH Dr. P. Y. Lam and SFDA Commissioner Mr. Shao Mingli met in late May to sign this agreement.

According to Dr. Lam, this agreement will act to enhance the regulatory control of drugs and medical devices between Hong Kong and mainland China. Hong Kong has been a Special Administrative Region (SAR) of the People’s Republic of China (PRC) since July 1997.

This increased cooperation is in the interest of both people in mainland China and Hong Kong. The public in these two places have high expectations for medical devices, Chinese medicines, and Western medicines.

The agreement includes enhanced cooperation on the following regulatory issues:

  • Regulation and registration of Chinese medicines, drugs, medical devices
  • Safety information and GMP
  • Clinical trial monitoring with regards to Western and Chinese medicines
  • Training of personnel

This meeting also established that working meetings will be held in the future when necessary.