Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Human Generic Drug Requirements in the APAC Region: Distinctions and Similarities Influencing the Development Strategy

Dr. Marion Petra Schergaut (Abschlußjahr: 2013)

Summary
Language: English

For a generic drug company the proper planning of the development strategy is the essential item for market success. In alignment with the marketing strategy, the corresponding regulatory requirements have to be considered. Compared with local or regional players for a globally acting generic drug company, the fulfilment of all requirements worldwide for one drug product is a huge challenge. Not only the worldwide requirements but also being competitive regarding cost and time are formidable challenges. Nevertheless, the enormous generic market growth, expected to reach the $1 trillion mark by 2015 with approximately $400 billion to $430 billion (39%) arising from generic drug sales and with the largest market size expected in the APAC  region (61%) in 2016, puts high pressure on globally acting generic companies and pushes them to accept these challenges.
In comparison to other market regions like EU or US, the APAC region is a combination of differently developed generic markets and a differentiated regulatory framework. Not only one agency is giving the rules, but several. Harmonization initiatives like the one of the ASEAN member states are a good example for contribution to the worldwide regulatory requirement harmonization efforts. However, still and even inside the APAC region, besides similarities numerous country specific requirements do exist. Consequently, the marketing strategy and the development strategy always have to be considered together. The range and diversity of the generic market development as well as the regulatory requirements influencing one another in the APAC region is reflected by the three countries South Korea, Indonesia and Pakistan.
To overcome the challenges of requirement fulfilment, cost savings and first to market access, a development strategy should be set-up in two levels: one basic level and one specific level. For the first basic level, the lowest common denominator with regards to the regulatory requirements to be fulfilled in alignment with the marketing strategy has to be figured out. For the second specific level, all mandatory requirements of the countries defined for the planned market access have to be taken into account. Here the same principles have to be applied for a regional or a global development strategy. Additionally, to these principles the definition of key countries and the prioritization are necessary tools to be applied. Furthermore, care has to be taken that the emphasis is laid on requirements with the most impact on cost and time, for example the stability program, the specification and the bioequivalence documentation.
Implementation of such development strategies will enable globally acting generic drug companies to be competitive, even in the APAC region, and to participate successfully in the expected market growth in the near future.

Pages: 90,
Annexes: 02, Pages: 05