DDReg Pharma

Regulatory Information Management Systems

Regulatory Information Management Systems

Managing regulatory information for a pharmaceutical product along all stages of its life cycle is a key challenge in the pharmaceutical industry. Now, as more opportunity markets emerge bringing their own stringent regulations and changes in previous regulations, managing regulatory information is becoming increasingly complex which can delay market access for products. Furthermore, information is gathered in separate systems that can be disconnected from each other which can also cause hurdles and prolong the product-to-market process. Thus, Regulatory Information Management System (RIMS) tools are needed to consolidate and integrate such information onto one system to enable a holistic and efficient approach to RIMS, while maintaining regulatory compliance.
Adopting digitization to systematically manage regulatory data embraces advanced analytics to do so. This would allow better data to be recorded so that data could be monitored and shared in a more efficient manner which would smoothen operational workflow. Additionally, businesses would be able to extract necessary insight and apply them for regulatory strategy decision-making. RIMS tools also incorporate automation for tasks and processes that are time-consuming and repetitive. Automation technologies such as machine learning (ML) and process automation can enhance processes such as event capturing and managing workflow. From a business perspective, RIMS tools allow transparency when conducting regulatory functions and interactions between internal and/or external collaboration, be it other contenders, stakeholders, or regulatory partners. As the trend for outsourcing regulatory functions increases, the need for secure, cloud-based platforms that exploit automation and technology for efficient operations is more than ever. No doubt this would facilitate better collaboration between all relevant parties [1].
Scope for RIMS tools in Asia
The pharmaceutical market is rapidly growing in Asia and providing immense opportunities for pharmaceutical development. Already, Asian countries such as China, Japan, India, and Korea rank among the top 10 economies in the world [2]. Thus, the Asian market is increasingly becoming attractive for companies around the world due to not only its strong economies, but also its population size. Needless to say, there is a positive correlation between population size and healthcare needs – with more people comes increasing healthcare needs. Furthermore, healthcare needs increase in countries where the ageing population is relatively high, like in Japan [3].

Undoubtedly, it is important to be aware of changes in regulatory requirements and the overall regulatory landscape, to successfully enter the Asian pharmaceutical market. With pharmaceutical product registration regulations becoming more stringent and new policies being implemented to support drug innovation, international companies could face challenges in bringing their products to the market. Indeed, such companies look to outsource their regulatory activities to third-parties that have deep experience and success in Asian markets [4]. The rise in regulatory changes within this market has also provided a platform of opportunities for exploiting regulatory technology- or Reg Tech. According to the Irish Advantage Report, the reason behind the growth of RegTech is a result of “rapid development of emerging Asian markets and financial systems, increased investment in new technologies and digital transformation, greater regulatory acceptance, and extensive infrastructure development” [5].

Given the growing economy of Asian countries such as Japan, Korea, Singapore etc, the increase in pharmaceutical product need to fulfill healthcare requirements coupled with investments in digitization and new technologies, provides an attractive and opportunistic market for RIM systems particularly for achieving rapid market approvals as smoothly and quickly as possible. At DDReg Pharma, we have leveraged technological innovation and our regulatory intelligence to assist pharmaceutical companies in providing dynamic regulatory data to authorities and various stakeholders. Our RIMS tool manages regulatory product lifecycle to ensure first-time right filings for all products- be it generics to biosimilars- in regulatory and emerging markets.
References and further reading:

[1] Oracle White Paper: Product Lifecycle Management for the Pharmaceutical Industry

[2] The World’s Largest Economies  

[3] Nomura S, Sakamoto H, Glenn S, et al. Population health and regional variations of disease burden in Japan, 1990-2015: a systematic subnational analysis for the Global Burden of Disease Study 2015 Lancet. 2017;390(10101):1521-1538.

[4] Asia’s changing regulatory environment and pharma outsourcing

[5] The Iris Advantage- The State of RegTech in APAC

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