Regulatory Strategy and Clinical Requirements for Registration of Fixed Dose Combinations as per Global Perspective in South Africa, ASEAN, GCC and their Comparison with EU and U.S.

Abstract

The Pharmaceutical market is growing leaps and bounds globally. The Pharmaceutical industry discovers, creates, delivers, and markets medications or pharmaceuticals for use on a large scale progressively. Pharmaceutical organizations are dealing with generics or branded drugs and medical devices. However, they are liable to varied laws and regulations that govern the licensing, testing, safety, adequacy, efficacy, patenting and promotion of medications. These help them to maintain the quality of the products. Till last decade the pharmaceutical sector was room around patent protection as majority of block buster molecules were patented by innovator pharmaceutical companies. However, from 2018 to 2025 the era will be changed as many of the patents are getting expired and because of this reason two separate entities having complementary advantage to each other can be clubbed in single pharmaceutical dosage form to achieve better patient compliance. Here comes the role and significance of Fixed Dose Combinations (FDCs). Fixed dose combination medicinal products are now increasingly being used to improve patient compliance, to get benefit from the complementary effects of the two different medicinal products given together and for their similar other merits. The proposed FDC ought to be based upon substantial therapeutic standards. Each of the fixed dose combination must be carefully justified and clinically applicable. Various countries have their own clinical requirements for getting market approval of particular FDC into that country. Based upon the country-specific clinical-regulatory requirements, one can be able to frame a regulatory strategy for the FDC market approval in a particular country taken into consideration. Regulatory strategy is the key component of any pharmaceutical product development phase. It helps to align all the regulatory activities to bring to the market a new or modified product along with the business methodology for that product. The present dissertation work mainly focuses on the various clinical requirements for the registration of fixed dose combinations for market approval in regulated and emerging markets taken into account. Based on them and other regulatory requirements, the regulatory strategy has been framed for each of the market to gain market approval for FDC in that specific market region. The strategy framed in this dissertation work is based upon two scenarios for marketing FDCs – one is the case where FDC is not globally approved and marketed , and the other one as the case where it is being marketed already in US and Europe as regulated markets, but not in any other countries. In order to frame a regulatory strategy, intense review of documents and documented work is required, which has been highlighted in the current thesis. In case of FDCs, almost all the other regulatory requirements remain same as for the other solid oral formulations, except the clinical ones which do show significant change during FDC registration. So these requirements are needed to be focussed upon more while dealing with the fixed dose combinations registration process to gain their market approval. In conclusion of the present work, comparative study of the clinical-regulatory requirements has been done between the emerging markets and the regulated markets being considered.