Berita Ubat-ubatan
August 2000

Regulatory Control Beyond 2000

Separate Manufacturing Facilities For Cephalosporins

Warning Label for products - NSAID

Registration of Products Containing Insect Repellants

Warning for Products containing Hydroquinone

Actions To Be Taken Against Products Containing CISAPRIDE (PREPULSID)
Licensing Update - June 2000

The Changing Pharmaceutical and Traditional Medicine Premises Landscape: 1987 - 2000

Additional Indications Approved for Registered Products

GMP News

Quality Control Training Course

Sources of products registered with DCA As At 30.6.2000

New Products Approved for Marketing in Malaysia

NPCB officers to contact

Clinical Trials

Following a review of the warning label required for products containing Hydroquinone, the DCA secretariat has issued a circular dated 20^th July 2000 to standardize the warning label.

The outer label/box of all products containing hydroquinone must now be labelled as follows:

WARNING Some users of this product may experience skin irritation. Should this occur, stop using and consult a medical doctor.

For products that do not contain any sunscreening agent, a statement should be included in the package insert to advise users to either use a sunscreening agent or protect themselves from sunlight or to use the products only at night.

Drug registration holders can continue to use the previous warning label until such stocks have been depleted, after which they must replace with the new warning label as mentioned above. For products which do not have any warning labels at all, registration holders are given a grace period of 3 months to ensure that their products carry this warning on the labels. A copy of the label with the new warning should be submitted to the DCA Secretariat for updating the individual product dossier.