Deadline looms to meet new label and insert requirements in Taiwan

The clock is ticking for drugmakers selling products in Taiwan. They have about 6 months to meet new guidelines for product labels and inserts to help consumers understand what their drugs are all about or face financial penalties.

By June, they will be required to make sure the packaging as well as inserts for prescription and over-the-counter meds include an explanation that can be clearly understood of what their products are for and what the potential side effects could be, the Taipei News reports. Those that fail to meet the deadline can face fines up to $60,700 per infraction.

The rules require drugmakers to list information in order of importance with the drug name first, followed by its purpose, warning, directions and dosage, a Taiwan FDA official told the Taipei News. Sides of packages must also carry info on active ingredient, purpose, warnings, directions and dosage, Chi Jo-feng, an administration official, told the newspaper. Those companies that don't meet the deadline can face penalties that will range from NT$30,000 and NT$2 million ($910 to US$60,698), Chi said.

The new rule stems from a government survey that found that 59% of respondents said they did not know the name of the drug they were taking. Half the respondents said they had not read the information accompanying the drug and so didn't know about its side effects or even the intent of the drug.

It is a problem that all countries wrestle with. The FDA this year said in direct-to-consumer print ads, it wants pharma advertisers to capsulize information on a drug's risks, and just include the "most important" potential side effects rather than using a full page of fine print that can overwhelm.

- read the Taipei News story

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