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The Regulatory Standards that Facilitate Quality Health Care Outcomes

Challenges in the global regulatory environment coupled with increased demand for patient access to new medical treatments have put pressure on authorities across Asia to strengthen their regulatory processes.

Regulatory agencies are engaging in capacity building initiatives, including the use of priority pathways, reliance in the prior reviews of trusted authorities and work sharing to facilitate better resource utilization. Over the past several years, the Chinese National Medical Products Administration (NMPA) acknowledged that their regulatory system was not equipped to keep pace with the demands of an evolving global industry. It faced challenges such as low standards for new product registrations, low-quality submissions and a lack of risk-based, scientific regulatory systems and processes.

Government-mandated 2015 regulatory review improvements in China have resulted in 133 new drugs being approved though a new priority route and a significant application backlog decrease. A number of other countries in Asia, including Indonesia, Malaysia, Singapore and Thailand, have also established new frameworks to more efficiently bring new treatments to patients.

As Southeast Asia looks to further strengthen regulatory processes and ensure new medicines can be made available to patients, strong intellectual property (IP) protections will also be critical. For example, increased regulatory data protection and patent protection for medicines help to promote market competition and facilitate innovation that ultimately reinforces quality health care outcomes for patients through opportunities like clinical trials. Singapore has adopted more effective patent protection and enforcement policies and has seen higher levels of clinical research as a result. For example, in 2017, Singapore conducted an average of 33.7 new clinical trials per capita and its pharmaceutical industry is expected to grow by 7% over the next five years.

Improved regulatory and IP systems can help encourage continued medical progress throughout Asia.

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