Taiwan Streamlines Registration Documents for Some Medicated Cosmetics

From 1 July 2013, manufacturers and importers of medicated cosmetics can submit less technical documents for examination and registration of their products on the condition that factories have obtained the voluntary cosmetic good manufacturing practice (GMP) certificate and the products have passed the inspection of cosmetic products of the same dosage and formula.

Technical information, including the inspection specification, the testing method and report as well as the functional data such as data of sun protection factor (SPF), sensitization test, etc., need not to be submitted but only recorded for further reference by companies themselves.

After simplification, manufacturers and importers are just required to provide the following information:

• A form for review of examination and registration of medicated cosmetics;
• An application form;
• An examination form;
• An affidavit; 
• A license copy          
• Label and leaflet;
• A copy of the GMP certificate

Reference Link

Taiwan FDA news alert