Regulatory Focus™ > News Articles > Taiwan Regulators in Push to Switch More Drugs to OTC Status

Taiwan Regulators in Push to Switch More Drugs to OTC Status

Posted 20 January 2015 | By Michael Mezher 

Taiwan Regulators in Push to Switch More Drugs to OTC Status

The Taiwan Food and Drug Administration (TFDA) announced this month that it will be reclassifying 13 prescription drugs to be available over the counter (OTC), the Taipei Times reports. The move is part of a larger push in Taiwan to improve access to basic medicines and reduce healthcare spending.

The regulator is planning for the reclassified products to be available for OTC sales in June 2015.

Self-Medication

TFDA said it is looking to reclassify as many prescription products as it can to encourage the practice of “responsible self-medication.” So far, TFDA has selected products which include common painkillers, allergy medications and gastrointestinal drugs to be reclassified.

In a press conference earlier this month Liu Li-ling, division of medicinal products director at TFDA, said just there are just 425 OTC drugs licensed for sale in Taiwan compared to “more than 26,000 [licensed] drugs, of which only 7,261 are non-prescription medications."

In Taiwan, non-prescription drugs may be sold without a prescription under the supervision of a pharmacist.

In comparison, there are more than 300,000 drugs marketed as OTC in the US, according to the US Food and Drug Administration. By boosting the number of available OTC products, the Taiwan government hopes to save on other areas of healthcare cost, such as insurance premiums and hospital care.

Patient Safety a Concern

Though the selected products are generally considered safe, TFDA plans to supplement the measure with more understandable labeling and instructions for patients.

Others remain skeptical that improved labeling and instructions will be sufficient. In a statement to The China Post, Wang Tsung-dao, a physician at the National Taiwan University Hospital Heart Center, cautions drugs such as low-dose aspirin can have serious side effects if taken improperly. Others have added concerns about assistants and other unlicensed staff at pharmacies lacking the experience to identify risks for patients taking certain medications.

 

Taipei Times

Categories: Regulatory News

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