On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the intellectual property legal framework with...more
10/20/2020
/ China ,
Generic Drugs ,
Hatch-Waxman ,
Innovation ,
Intellectual Property Protection ,
Life Sciences ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
On October 10, thirteen years after China’s Measures for the Administration of Drug Recalls first took effect, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) proposed an...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
The past year is set to be a milestone year for China’s pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red tape for new drug...more
5/21/2019
/ Biopharmaceutical ,
Biotechnology ,
CGMP ,
China ,
Drug Pricing ,
Generic Drugs ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements
Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications -
On 28 March China's National Medical Products Administration (NMPA) published a list of an...more
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 January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. ...more
On 8 August 2018, in an unprecedented regulatory action, the China National Drug Administration (CNDA) called on international pharmaceutical companies to bring 48 new drugs to China. These new drugs are viewed to be urgently...more
This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more
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
4/4/2018
/ 3D Printing ,
Acquisitions ,
Artificial Intelligence ,
Biologics ,
Biosimilars ,
Biotechnology ,
Blockchain ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Digital Health ,
Distributed Ledger Technology (DLT) ,
Drug Pricing ,
Emerging Markets ,
EU ,
General Data Protection Regulation (GDPR) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Reimbursement ,
Mergers ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Private Equity ,
Regulatory Oversight ,
Supply Chain ,
Transfer Pricing ,
UK Brexit ,
Yates Memorandum