DRUG REGISTRATION SCHEME (Progress report)

Mr Chew Heng Ching asked the Acting Minister for Health if he will report on the progress of implementation of the compulsory drug registration scheme introduced in June 1987.

The Acting Minister for Health (Mr Yeo Cheow Tong): Mr Speaker, Sir, drug regis- tration under the Medicines Act commenced on 30th June 1987. It is being implemented in four phases. Phase I deals with the more potent and critical drugs such as antibiotics, tranquillisers, hypnotics, cardiovascular and anti-cancer drugs, vaccines and human blood products.

The processing of applications for product licences, manufacturers and wholesalers licences under Phase I is progressing smoothly. To date, a total of 3,100 applications have been received. Of these, 1,036 have already been processed and the relevant licences issued. My Ministry expects to be able to complete the registration of the remaining Phase I products by 1st July 1988.

Some delays in the processing of the applications for product licences were encountered in the initial stages. They arose because applicants were providing insufficient information as they were not familiar with the drug registration process. These initial teething problems have since been overcome.

Phase II of the drug registration will begin after the completion of Phase I. This will involve the registration of drugs used in the treatment of respiratory, digestive and urinary tract diseases. The whole registration exercise encompassing the four phases is expected to be completed by mid-1991.

Mr Chew Heng Ching: Sir, will the scheme be extended to registration of traditional Chinese medicines in any of the subsequent phases?

Mr Yeo Cheow Tong: The Ministry does not intend to extend the scheme to traditional medicines.