Differentiation between the Regulatory paths placed on Mouthwashes in the US and EU

Journal Title: International Journal of Drug Regulatory Affairs - Year 2018, Vol 6, Issue 2

Abstract

Regulating oral rinses has been and still is a topic of debate and confusion. Oral rinses are products that are mainly used for cleaning, perfuming and changing the appearance of the teeth, which in turn improves the individual’s external appearance. Adding medicinal ingredients to these rinses, it can then be used for the elimination and/or prevention of some oral diseases, an example being gingivitis. The United States Food and Drug Administration placed guidelines which state that mouthwashes with possible therapeutic properties should be registered as drugs rather than cosmetics. Meanwhile, on a different continent, Germany along with the other members of the European Union decided not to categorize mouthwashes as drugs, but rather as cosmetics, using its sole purpose of cleaning and beautifying the teeth as the excuse. The following research will thoroughly differentiate between the diverse regulatory systems forced upon mouthwashes across the two countries—the United States and Germany.

Authors and Affiliations

Philip Saddik, John Pappan

Keywords

Related Articles

COMMON DEFICIENCIES RAISED BY VARIOUS REGULATORY AGENCIES

Timely Product registration is a challenge in today’s scenario. Regulatory agencies are keen in assessing CTD sections like redefining starting material of Drug substance manufacturing, Pharmaceutical development, impuri...

Study the effects of Nipah Virus – A Review

The effect of Nipah Virus Infection is increasing day by day in today’s scenario and more number of cases are found in various countries. In India it was discovered in Sikkim, Siliguri and West Bengal. It is near borders...

COMPARISON OF GLOBAL REGULATORY GUIDELINES FOR AVAILABILITY OF DIFFERENT BIOWAIVER PROVISIONS AND APPLICATION REQUIREMENTS OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER.

To waive a complete and systemic Bioequivalence (BE) study, Biowaiver or Request for a Biowaiver is a fast track approach to boost the drug development process. Over the past three-four years the Biowaiver market shows g...

REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA

India is a huge market for medical devices and is increasing constantly for the last few years. The registration certificate and import license is mandatory for a manufacturer of India who wishes to import any medical de...

REGULATORY TECHNICALITIES FOR DRUG PRODUCT REGISTRATION IN BRAZIL

Brazilians are demanding better healthcare and modern medicines, presenting significant opportunities for foreign investment. In Brazil, medicinal product registration is an extensive process. To do business in Brazil is...

Download PDF file
  • EP ID EP329295
  • DOI 10.22270/ijdra.v6i2.229
  • Views 91
  • Downloads 0

How To Cite

Philip Saddik, John Pappan (2018). Differentiation between the Regulatory paths placed on Mouthwashes in the US and EU. International Journal of Drug Regulatory Affairs, 6(2), 8-13. https://europub.co.uk/articles/-A-329295