Chinese Medicine Regulatory Office


To enhance the quality management of proprietary Chinese medicines (“pCm”) manufacturing industry in Hong Kong, the Chinese Medicine Ordinance stipulates that a pCm manufacturer who follows good practices in the manufacture and quality control of pCm may apply to the Chinese Medicines Board (“CMB”) formed under the Chinese Medicine Council of Hong Kong for a Certificate for Manufacturer (Good Manufacturing Practice in respect of pCm) (i.e. GMP Certificate in pCm).

To facilitate the implementation of quality management, the CMB prepared the “Hong Kong Good Manufacturing Practice Guidelines for Proprietary Chinese Medicines” (“Guidelines”) in respect of practices in manufacturing and quality control of pCm in 2003. It aims to promote the standardization of the pCm manufacturing industry, and to assure the quality and safety of pCm, thus to safeguard public health and to boost the public confidence in using pCm. The Guidelines covers fundamental items of Good Manufacturing Practice (“GMP”) in respect of pCm, and can serve as reference for personnel engaged in the Chinese medicines manufacturing industry.

In order to work out a timetable for mandatory compliance with the GMP for the manufacture of pCm, and to cater for the operational needs of the trade and allow sufficient preparation time for the implementation of GMP, we are collecting comments from the trade.

In addition, we would meet with pCm manufacturers who are interested in the implementation of GMP and already have preliminary designs of their premises, and explain to them content of Guidelines as well as discuss with them on various issues including the premises setup, facilities and manpower, in order to assist them to implement GMP.

In order to facilitate traders who are interested in applying for GMP Certificate in pCm and the public to have a better understanding in GMP for pCm, we are delighted to introduce this “One-stop” web resources platform to you. It aims to provide you with comprehensive and highly relevant information!