Abstract

CHALLENGES IN REGULATORY FILING OF GENERIC PRODUCTS IN EUROPE AND MALAYSIA

Buchepalli Ramakrishna*, K. Nagamani, Ch. Naga Padmini, S. Kali Teja, Ch. Durga Manjusha

Abstract

The main aim of this topic is facing challenges and overcoming when filling Generic Products. The objective of this topic is to review and compare generic drug filing process along with their challenges in different countries. Examples: Generic drug filling process in USA is ANDA(Abbreviated New Drug Application). Generic drugs are filled seperately through EMA (European Medical Agency) in Europe. In India generic drugs are filled to Drug Controller General of India (DCGI). Regulatory Challenges facing in Europe and Malaysia. Access to healthcare professionals and services tends to be concentrated in urban areas and it can be difficult for those residing in remote and rural areas to get access to quality pharmaceuticals and treatment. The majority of pharmaceutical products in the region are imported, either as the final product, or as base materials which are then manufactured into the finished product locally. There are serious problems with high volumes of counterfeit products making their way onto the market. One of the biggest challenges when entering the European market is the multitude of languages, which results in a large number of associated country-specific pack formats. Within the 28 member states of the EU, there are 150 regional and minority languages, of which 23 are recognized working languages. The purpose of the study is to compare generic drug registration and requirements in ASEAN countries & to find out the differences in guidelines. The focus on countries like Indonesia and Thailand is because of high population rate, maximum share of ASEAN pharmaceutical market, low income. But these countries are ranked after Vietnam and Philippines because of some restriction by countries government for foreign players. Singapore and Malaysia are the only countries in ASEAN, who have well established pharmaceutical regulations and more strict to quality & safety of drugs.

Keywords: Challenges, Europe, Malaysia, CTD, ACTD.