Opportunity or challenge? Favorable policies promote the increase of drug approval(2)

China:

China has been highly regarding medical reform in recent years, which is a challenge and development opportunity for the pharmaceutical community.

The Opinions on the Reform of Review and Approval System for Drugs and Medical Devices issued by the State Council in August 2015 has kicked off deepening of China’s pharmaceutical product regulatory system reform. Thereafter, a series of policies promoting drug approval has been introduced in succession, with the pilot work of Marketing Authorization Holder (MAH) system, quality and efficacy consistency evaluation of generic drugs, clinical trial data self-inspection and checking, and medical device classification adjustment, etc. implemented successively, to solve the problem of serious backlog of pharmaceutical product registration approval, and a batch of innovative and clinically imperative pharmaceutical products and medical devices has been approved for marketing with priority.

The Opinions on Deepening the Reform of the Review and Approval System and Inspiring Innovation of Drugs and Medical Devices was jointly issued by the General Office of the Communist Party of China Central Committee and General Office of the State Council on October 8, 2017, which will further deepen the reform of the review and approval system of pharmaceutical products and medical devices based on work of recent two years. There will be other favorable policies for novel drug R&D ready to come out, which will be of milestone meaning to the innovative development of China’s pharmaceutical industry.

1. Comprehensively support drug innovation and strengthen innovation protection

The Reform Opinions clearly specifies a series of measures to support drug innovation, including: 1. To explore and build the pharmaceutical patent linkage system to protect the legitimate rights and interests of patent applicants and thereby reduce the risk of infringement; 2. To implement the pilot work of patent term compensation system, to offer corresponding patent term compensation for novel drugs delayed the marketing time due to clinical trial, review and approval; 3. To protect the pharmaceutical product trial data, to offer a certain data protection period for trial data submitted in drug registration application, which will help innovative drugs seize the first market opportunities; 4. To support the clinical application of innovative drugs, which mainly reflects in the dynamic adjustment of the medical insurance catalog, for excellent novel drugs to be timely added in the medical insurance catalog to benefit patients.

2. Generic drugs will still be an important part of China’s drugs for a long period to come

It's quite worth mentioning that this Reform Opinions still clearly points out support of generic drug production. China still has a gap with many developed countries in the Europe and America in drug innovation due to the late start of modern pharmaceuticals of China, therefore, China still needs to vigorously support generic drug production for Chinese patients to enjoy the same treatment with patients of developed countries in a more convenient and more affordable manner, and it may reduce drug prices besides meeting supply of corresponding drugs. Seen from the current situation, generic drugs will still be an important part of China’s drugs for a long period to come.

3. Threshold for injections will be raised again

We can find that there were frequent incidents of injections and the drug regulation system’s frequent "intervention" with injections some time ago, and in my opinion, those incidents well lay the groundwork for this Reform Opinions to raise the threshold for injection approval. The Reform Opinions clearly requires pharmaceutical injection review and approval to be strict and reevaluation of existing injections to be conducted, which clearly signals that injections will not be the first choice for treatment, and for clinical needs that can be met by oral preparation and other dosage forms, injection dosage form will never be encouraged, so as to reduce the using risk.

4. Increase support of TCM

As national treasure of China, TCM shall be vigorously promoted and mined, which has been an important signal released by China recently. Many recent policies also have obviously reflected that China is trying to create an environment for the sound development of TCM. The Reform Opinions has clearly mentioned support of TCM inheritance and innovation: to coordinate relationship between giving play to TCM traditional advantages and requirements of modern pharmaceutical product R&D through establishing perfect registration management system and technical evaluation system that meet TCM characteristics, and give full play to the treatment advantages of TCM in some diseases as oriented by efficacy and clinical application.

Pharmaceutical enterprises shall seize the favorable condition, insist on innovation, and promote product quality and core competitiveness. They can maintain profitability and have long-term development in the reshuffle of the pharmaceutical industry only by better meeting the public’s demand. Opportunities always coexist with challenges. Let’s wait and see who will be the last winner!

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