Hong Kong Regulations

PHARMACY AND POISONS REGULATIONS - REGULATION 36B

Clinical trials and medicinal tests

(1) For the purpose of conducting a clinical trial on human beings or a
medicinal test on animals application shall be made in writing to the 
Committee and shall be accompanied by the fee prescribed in the Ninth
Schedule.

(2) A sample of the product or substance and a copy of the protocol for the
trial or test shall accompany the application.

(3) The Committee may issue a clinical trial certificate or medicinal test
certificate in the form prescribed in the Eighth Schedule valid for a period
not exceeding 2 years on payments of the fee prescribed in the Ninth Schedule.
(See Eighth Schedule Form 12)

(4) Any person aggrieved by a decision of the Committee under this regulation
may, in the prescribed manner, appeal to the Tribunal against that decision.
(L.N. 369 of 1980) (L.N. 137 of 1978; L.N. 360 of 1980)