Navigating Regulatory Diversity: A Comparative Study of Drug Product Registration Frameworks in Malaysia, Ghana, Kuwait and India

Abstract

Pharmaceutical products have to follow a set of rules that will eventually prove their quality, effectiveness, and safety before they can be sold in the market. However, it is important to note that the process and requirements, such as what is needed from the manufacturer, differ from one country to another. This is a problem for companies that want to register their products in several countries. The aim of this research project is to compare and highlight the regulation of drug product registration in Malaysia, Ghana, and India, as well as the role of the regulatory authorities in these countries and the steps that will be undertaken by companies in order for their products to gain marketing authorisation. There are four major areas that we are going to discuss in detail: what documents are required to be submitted to each country, how each country will evaluate the documents that are submitted to them for approval, the timeframe to get approval from each country, and what document are required to be prepared to get approval. The regulatory process in Malaysia follows the ASEAN common technical dossier (ACTD), whereas in Ghana and India, it follows a different system. In addition to that, some of the similarities and dissimilarities that exist in the regulatory process of both countries will also be addressed in this research. Moreover, it will also highlight how these dissimilarities will create a problem in the expedited approval of product registration services to firms. Finally, it will highlight some of the challenges that pharmaceutical firms are likely to face in a different regulatory environment. The results of the research would be beneficial for the international drug regulatory professionals. It would be beneficial for the researchers of international drug registration. In the end, the significance of the comprehension of the diversity of regulations would be highlighted.

Conclusion: The review also explains a brief about different regulatory requirement for Registration of drug product in Malaysia, Ghana, India and Kuwait. And also, comparative data for registration of dossier application in Malaysia, Ghana, India and Kuwait.