We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane Summerfield, and partners Melissa K. Bianchi,...more
This article provides a general overview of certain Chinese legal considerations for licensing and collaboration deals in the life sciences industry. In particular, this article focuses on two types of transactions...more
After years of waiting, China’s Ministry of Science and Technology (MOST) finally released the final version of the Implementing Rules on the Human Genetic Resources Administration Rules (Implementing Rules) on 1 June 2023,...more
Life sciences companies engaged in early development programs face a number of strategic considerations, such as where and how to administer the early stage scientific studies and each phase of clinical trials that are needed...more
As part of a new Asia-Pacific (APAC) Life Sciences and Health Care webinar program designed both for companies with commercial interests in APAC and for companies based in the region, Hogan Lovells is hosting a special...more
The Ministry of Science and Technology of China has finally issued the draft of Implementation Rules for the Regulations of Human Genetic Resources Administration for public comments on March 21, 2022, which gives more...more
On 29 April, China’s National People’s Congress released the second consultation draft of the Personal Information Protection Law (New PIPL Draft). Public comments are open through 28 May 2021. The first draft of the Personal...more
6/3/2021
/ China ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
International Data Transfers ,
Legislative Agendas ,
Personal Data ,
Personally Identifiable Information ,
Popular ,
Regulatory Agenda ,
Standard Contractual Clauses
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
As the coronavirus (COVID-19) spreads across the world, creating new epicenters, this is perhaps an opportune moment to look back at the lessons learned from China, where it appears that the outbreak is under control, in...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
2/26/2020
/ 3D Printing ,
AIDS ,
Analytics ,
Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Blockchain ,
California Consumer Privacy Act (CCPA) ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Digital Health ,
Drug Distribution ,
Drug Pricing ,
EU ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
HIV ,
Incident Response Plans ,
Intellectual Property Protection ,
Life Sciences ,
Medical Device Data System ,
Medical Devices ,
Medical Software ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Procurement Guidelines ,
Regulatory Standards ,
Research and Development ,
Right to Try ,
Robotics ,
Supply Chain ,
Telehealth
China is marching on to be the world's pioneering cashless society but unfortunately there is an almost complete absence of foreign counterparts in the huge Chinese domestic or cross border transactions initiated from China....more
8/27/2019
/ China ,
Critical Infrastructure Sectors ,
E-Commerce ,
Foreign Investment ,
Foreign Investment Entities (FIEs) ,
Internet Retailers ,
Licensing Rules ,
Payment Services Directive ,
PBOC ,
Regulatory Oversight ,
Telecommunications ,
Third Party Payments
On 28 May 2019, the Cyberspace Administration of China (CAC) released the draft Measures on the Administration of Data Security (Data Security Measures, see our in-house English translation here) for public...more
The cybersecurity classified protection regime attracted significant attention when it was included in the Peoples Republic of China (PRC) Cyber Security Law promulgated in 2017 (the CSL). The CSL mandates that network...more
A Hogan Lovells study comparing regulatory requirements in the European Union, China, and the United States shows the complexity and uncertainty of the regulatory framework relevant to Internet of Things (IoT) in Europe.
...more
3/20/2019
/ 5G Network ,
Artificial Intelligence ,
China ,
EU ,
Infrastructure ,
Internet of Things ,
Net Neutrality ,
Popular ,
Regulatory Standards ,
Telecommunications ,
Wireless Industry
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
3/18/2019
/ Artificial Intelligence ,
Asia ,
Biologics ,
Biotechnology ,
Data Breach ,
Digital Health ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
On December 29, 2017, the Standardization Administration of China, jointly with the PRC General Administration of Quality Supervision, Inspection and Quarantine, issued the Information Security Technology – Personal...more
11/14/2018
/ China ,
Consumer Protection Laws ,
Cooperative Compliance Regime ,
Cybersecurity ,
Data Collection ,
Data-Sharing ,
General Data Protection Regulation (GDPR) ,
Information Technology ,
Personal Data ,
Personally Identifiable Information ,
Popular ,
Regulatory Oversight ,
Regulatory Requirements
China's new rules for Internet-based medical services – telemedicine, Internet hospitals and Internet-based diagnosis came into force on 17 July 2018.
...more
10/31/2018
/ China ,
Diagnostic Tests ,
Electronic Prescribing ,
Health Care Providers ,
Health Information Technologies ,
Hospitals ,
Internet ,
Licensing Rules ,
Physicians ,
Telehealth ,
Telemedicine
In March of this year, the State Council released the Scientific Data Administrative Measures, a set of rules with the seemingly innocuous aim of collecting and making public the results of government-funded scientific...more
On March 21, 2018, the Chinese central bank and regulator of payment services operators (“PSOs“), the People’s Bank of China (the “PBOC“) circulated PBOC Announcement No.7 of 2018 (the “Announcement“) lifting the de facto but...more
On March 21, 2018, the Chinese central bank and regulator of payment services operators ("PSOs"), the People's Bank of China (the "PBOC") circulated PBOC Announcement No.7 of 2018 (the "Announcement") lifting the de facto but...more
On December 20, 2017, the China Food and Drug Administration (“CFDA“) released two draft documents for public comment:
(1) Conditional Approval for Urgently Needed Drugs Technical Guidance (the “Draft Conditional Approval...more