China\'s Regulatory Reforms

Promoting pharma innovations

Prasanthi Sadhu, Editor Pharma Focus Asia

In recent years, China’s investment in drug innovation has been on the rise. The country’s pharmaceutical market is second only to the US at approximately US$125 billion as of 2016 and is expected to increase at a CAGR of 30 per cent to US$575 billion by 2022. Interestingly, China has become the leader in API manufacturing and exports. Historically, the pharmaceutical market in China was inward-looking and lack of favourable regulatory climate deterred foreign investors from making strong in-roads. Of late the government has begun to reform the regulations to encourage innovation and decrease the regulatory burden on the life sciences industry. While entry to the market has not been a major concern, foreign companies have always been troubled by delayed drug approvals, IP violations, and lack of transparency. The biggest challenge was companies being forced to conduct local clinical trials in spite of receiving approvals in other countries.

In 2015, the China State Council brought about a new directive titled ‘Opinions on Reforming the Review and Approval System for Drugs and Medical Devices’, aiming to create a business environment that is conducive to high-quality generics and make the approval process more transparent. The China Food and Drug Administration (CFDA), the administrative body responsible for the regulation of medical devices and pharmaceuticals in the country, released a notice that aimed at deepening the review and approval system reform and encouraging innovation in drug development. This was the beginning of many such reforms or regulatory changes. There have been significant outcomes for the proposed regulatory changes. Acceptance of foreign clinical trial data for drugs, drug classifications, implementation of a marketing authorisation holder system, strengthening of IP protection etc., are some such changes. All these reforms brought in recently will have significant implications for innovation in the country’s pharmaceutical and medical devices markets.

Research & development activity in the country has picked up as the number of contract research organisations (CROs) has increased. Historically, Chinese pharma companies remained focused on generics and now they have slowly started investing and building capacities for innovative drugs. It is expected that by 2020, innovation in the biotech and pharma companies will move to a new phase and a lot of breakthroughs and innovative drugs are poised to be available for
patients by 2025. While on the one hand research capability in the country has seen improvement, on the other hand there’s still a gap in clinical research between China and the developed markets. To spur innovation further, enhancement in the quality of research from academia coupled with increasing the knowledge transfer towards commercialisation of research is required. In all, domestic and foreign pharmaceutical companies are presented with growth opportunities thanks to the changing regulatory reforms that propel innovations.

Cover story of this issue by Mingping Zhang, Vice President of Technology, PAREXEL Regulatory Consultant discusses the nuances of clinical and regulatory product development in China, and its similarities and contrasting aspects in comparison to the rest of the world.

--Issue 32--

Author Bio

Prasanthi Sadhu

Prasanthi Sadhu, Editor, Pharma Focus Asia

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