By Lance Yau
Snapshot
China is months away from fully implementing the guidelines required by its ICH membership. While this should facilitate drug reviews in theory, recent cases involving reviews in other markets highlight the importance of staying attentive to drug regulators’ attitudes regarding the reliability of China’s drug review standards. According to discussions with companies involved in multiple markets, this element requires additional layers of...
Dear USCBC members interested in healthcare and life sciences,
After a year of micro-oriented policies in response to COVID-19, China’s health policy space has returned its focus to longer-term priorities in 2021. The annual Two Sessions set broad goals for the year and beyond, with the release of the 14th Five-Year Plan. Among the new or upcoming changes are new regulations on medical insurance funds, implementation of the Biosecurity Law, market access measures for Hainan, and novel...
Dear USCBC members interested in the healthcare industry:
As part of USCBC’s regular monitoring of government and press sources, we wanted to share the below policy and news updates related to the healthcare sector.
Recent developments in the pharmaceutical industry have focused on IP provisions in draft amendments to the Patent Law. These amendments address the Phase One IP commitments of patent term extension, patent linkage, and allowance for supplemental data in patent...
Dear USCBC members interested in the healthcare industry:
As part of USCBC’s regular monitoring of government and press sources, we wanted to share the below policy and news updates related to the healthcare sector.
March saw the release of administrative measures on drug registration and drug production supervision, which further implements last year’s Drug Administration Law. These measures will regulate the R&D of innovative and follow-on drugs, as well as their full...
USCBC members interested in the healthcare industry:
To introduce myself, I have recently joined USCBC and will be covering the life sciences portfolio going forward. Thank you all for your patience as I was onboarding; I plan to get future updates out in more regular intervals. If you have any comments, questions, or general feedback on the content below or any related issues, please don’t hesitate to reach out!
Topics in this edition include life sciences outcomes from the...
USCBC members interested in healthcare:
This summer has seen some major developments in structural overhaul of China’s healthcare industry. The new Drug Administration Law and Vaccine Management Law were adopted by the Standing Committee of the National People’s Congress (NPCSC) in August and June, respectively, codifying regulatory reforms that have been introduced in recent years. China has begun implementing a nationwide initiative to achieve health targets by 2030 and is making...
Dear members interested in the health industry,
In mid-May, China’s State Council hosted a national health system reform conference which set broad priorities. Relevant regulatory bodies subsequently issued annual work plans reflecting key themes, including implementing and expanding the centralized drug procurement pilot program, promoting the reform of public and private hospitals and the health insurance system, and promoting “Internet Plus Healthcare” services. China also released...
USCBC members interested in the health sector,
On April 25, the National People’s Congress Standing Committee (NPCSC) released for public consultation several draft laws, including draft revisions to the Drug Administration Law and the second draft of the Vaccine Management Law. Comments are due by May 25, 2019.
Revisions highlight the government’s continued focus on ensuring quality, safety, and accessibility of healthcare. The laws both propose more...
USCBC members interested in the health sector,
China recently committed to ban fentanyl as a drug class, addressing a US ask in the on-going trade negotiations. Beyond this high-profile move, China has continued to focus on improving the quality, safety, and efficiency of its health sector. Recent developments in this update include measures to allow medical device applicants to communicate with the Center for Device Evaluation prior to submitting applications for examination...
USCBC members interested in the healthcare sector,
This healthcare industry update includes an overview of major developments in 2018 that provide some insight on trends and regulations to watch going into 2019. Following the vaccine scandal and institutional overhaul in 2018, there is likely to be greater scrutiny of the health sector in 2019. Other priorities continue to include controlling costs and improving patient access to health services and high-quality treatments,...
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In November, China’s government and health regulators issued a variety of documents moving forward with implementation of comprehensive health sector reforms. Improving quality and safety remains a core theme of recent regulatory and enforcement developments, particularly as the government has continued to manage the July vaccine safety scandal. Several of the documents also address reforms to the drug and device application and...
Health Insurance and Price Negotiations; Medical Device Approval and Clinical Trial Exemptions; More Clarifications on Government Health Reform
USCBC members interested in the healthcare industry:
As part of USCBC’s regular monitoring of government and press sources, we wanted to share the below policy and news updates related to the healthcare sector. As China grapples with demographic challenges and rising cancer rates, the government is making efforts to reduce the...
USCBC members interested in the healthcare industry:
As part of USCBC’s regular monitoring of government and press sources, we wanted to share the below policy and news updates related to the healthcare sector. The last month saw an acceleration in health sector reforms, notably with the release of drafts for comment on establishing a drug traceability and Unique Device Identification system. The government also clarified its role in healthcare spending, added drugs to the...
Dear USCBC members interested in the health industry:
The China National Drug Administration (CNDA) has released “Draft Guiding Opinions on Establishing a Drug Traceability System” for public comment. The final deadline to submit comments to the CNDA is September 20.
The State Administration of Market Regulation (SAMR) also issued a notice seeking comment on “Draft Regulations for Medical Device Unique Identification System”. The final deadline to submit...
USCBC members interested in the healthcare industry:
As part of USCBC’s regular monitoring of government and press sources, we wanted to share the below policy and news updates related to the healthcare sector. Topics this edition include enforcement of China’s anti-unfair competition law, government response to the latest vaccine safety scandal and calls to reduce the price of innovative drugs, as well as updates on China’s medical device regulatory reform and private...
Dear USCBC members interested in the healthcare industry:
As part of USCBC’s regular monitoring of government and press sources, we recently came across a number of policy and news developments related to healthcare:
NHFPC to Strengthen Regulation of Unfair Competition
CFDA to Enhance Innovation in the Food and Drug Industries
CFDA Issues New Regulation on Medical Devices Standards
Google, Tencent, and Sequoia Capital Invest in China AI Parma...
Dear USCBC members interested in the healthcare industry:
As part of USCBC’s regular monitoring of government and press sources, we recently came across a number of policy and news developments related to healthcare:
China to Accept Overseas Drug Clinical Trial Data
CFDA to Streamline Administration for Changes to Drug Manufacturing Locations
CFDA Seeks Public Comment on Drug Registration Measures
China to Strengthen Supervision of Infant...
Dear USCBC members interested in the healthcare industry:
As part of USCBC’s regular monitoring of government and press sources, we recently came across a number of policy and news developments related to healthcare:
China to Accept Overseas Drug Clinical Trial Data
CFDA to Streamline Administration for Changes to Drug Manufacturing Locations
CFDA Seeks Public Comment on Drug Registration Measures
China to Strengthen Supervision of Infant...
Dear USCBC members interested in the healthcare industry:
As part of USCBC’s regular monitoring of government and press sources, we recently came across a number of policy and news developments related to healthcare:
CFDA Policies Could Improve Efficiency for Foreign Drug and Device Companies
CFDA Notice on Supervision of Medical Device Testing Institutions
NHFPC Opinion on Establishing Tier 3 Public Hospital Accountant System
CFDA Opinion on...
Dear USCBC members interested in the healthcare industry:
As part of USCBC’s regular monitoring of government and press sources, we recently came across a number of policy and news developments related to healthcare:
Private Doctor and Registered Nurse Numbers Continue to Grow
MOST Issues the Thirteenth Five-Year Plan on Biotechnology Innovation
State Council Issues Notice on Deepening Medical and Healthcare...