On December 2, 2015, the President announced amendments to the Pharmaceutical Affairs Act.  Major amendments include: (1) a dealer or manufacturer shall establish a tracking or tracing system for the drugs publicly announced by the competent authority concerned (“Authority”), and the specific items to be recorded in such systems will be further prescribed by the Authority; (2) in order to avoid drug shortages, a duly-licensed pharmaceutical firm  selling a drug that has been announced by the Authority as an essential drug shall report to the Authority at least 6 months before the firm may become unable to continue to manufacture, import or supply the said drug; (3) in order to strengthen the management of the sourcing of drugs, the application for drug licenses now includes a registration item requiring information concerning the “the source of the drug”; (4) to facilitate drug safety for visually impaired people, drugs publicly announced by the Authority shall have labels, instructions or packaging with Braille or other assisting measure; and (5) the cap on criminal fine has been raised to NT$20 million, and NT$50 million for administrative fine; moreover, the caps on both fines for corporations have been raised up to 10 times of respective caps.