The maximum daily dose of over-the-counter vitamin C will increase to 2,000 mg from the current 1,500 mg. The door is also opening for vitamin products that package tablets and liquid together to be launched with only a filing, without separate approval or review.
The Ministery of Food and Drug Safety issued an administrative notice on the 3rd for a revision to the notice on the Standard Manufacturing Criteria for Drugs that includes these changes. The standards are being expanded to boost development of over-the-counter (OTC) drugs and broaden consumer choice. Over-the-counter drugs are medicines that consumers can buy directly at pharmacies without a doctor's prescription.
The Standard Manufacturing Criteria for Drugs is a system that standardizes the ingredients and content, efficacy and effects, and directions and dosage of over-the-counter drugs whose safety and effectiveness have already been confirmed. Products that meet the standards can be launched by going through only a filing process without safety and effectiveness reviews for each item, reducing development time and expense.
The core of this revision is adding dual formulations that combine tablets and liquids to the standards.
Until now, the standard manufacturing criteria recognized only single formulations, such as tablets or liquids, so even if the ingredient and content were the same, products packaged with both tablets and liquid had to undergo separate approval and review. As a result, from development to launch, considerable time and expense were required, raising concerns that there were limits to quickly supplying diverse products. With this revision, pharmaceutical companies will be able to launch related products with only a filing, without separate approval procedures.
The maximum daily amount for ingredients with strong consumer demand will also be expanded. Vitamin C will be raised to 2,000 mg from 1,500 mg, and simethicone, an antacid ingredient, will increase to 0.5 g from 0.18 g.
The standard manufacturing criteria for cold medicine and topical agents will also be expanded.
For cold medicine, glycyrrhizic acid and its salts will be newly added as active ingredients, and for topical analgesics, indomethacin and piroxicam will be newly included, while for topical astringents, hydrocortisone and prednisolone will be newly included. The Ministery of Food and Drug Safety also prepared standards for the amount of each ingredient, compounding ranges, and directions and dosage.
The standard manufacturing criteria for antidiarrheals will also be overhauled. To reduce confusion in the item filing process, standards will be clarified so that at least two probiotic ingredients, whose compounding ranges were previously unclear, can be compounded together.
Precautions for use were also updated to reflect the latest safety information. Drug interaction information for aspirin and aspirin aluminum was added, and precautions for patients with severe renal disease for pseudoephedrine and precautions for use during pregnancy for glycol salicylate were reflected.
An official at the Ministery of Food and Drug Safety said, "With this revision, we expect to promote the development of diverse over-the-counter drugs that meet consumer demand and to broaden consumer choice," adding, "We will continue to improve the Standard Manufacturing Criteria for Drugs based on scientific evidence and regulatory expertise."