Regulatory Requirements and Comparative Study of Cosmetics In Vietnam, Malaysia, Singapore, Philippines (Asean Countries) and Sri Lanka

Abstract

This work emphasis on the Regulatory requirements and comparative study for cosmetic products in ASEAN countries (Vietnam, Malaysia, Singapore, Philippines) & Sri lanka. In order to register the cosmetic product, it requires wide range of documents which shows the evidences that the cosmetic product desired to be registered is of the appropriate quality. Each country has different procedure and guidelines for the registration of cosmetic product, but the main purpose of each regulatory body is to achieve quality, efficacy and safety for the product being registered in its jurisdiction. To achieve quality, efficacy and safety for each product being registered and to follow the country specific procedures and guidelines is a much complicated task. Even if the same product is to be registered, there are various differences in the pathway and requirements for the registration of the product and in preparation of dossiers specific to the countries. Thus, switching from one market to another is a time consuming and lengthy process for the pharmaceutical companies. The purpose of this work is to outline major gaps in between the requirements and the registration procedures of cosmetic products in various different countries, and thus forming a regulatory strategy for preparation of dossier and product registration for same cosmetic product by understanding the regulations and country specific guidelines for product approval for ASEAN countries (Vietnam, Malaysia, Singapore, Philippines) & Sri lanka and comparing various different aspects like submission of notification, its Credentials, Language, validity period, fees etc In order to understand the regulatory differences between the countries, an example of Terbinafine Hydrochloride cream USP manufactured by Xyz Company is considered, for which comparison of guidelines and regulations along with dossier preparation has been done. Therefore this study will be helpful for better understanding of various regulations, dossier requirements and thus registration of cosmetic products in ASEAN countries (Vietnam, Malaysia, Singapore, Philippines) & Sri lanka