Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.
Some important developments during October include:
- SFDA Issues 2010 Annual Report on Drug Registration and Approval
- CCTV to Restrict Advertisement of Alcohol, Medical Institutions
- MOH Requires Improvement of the Reward and Penalty System for Antibacterial Drug Administration
- Draft Mental Health Law Submitted to NPC Standing Committee for First Deliberation
- SFDA: All Drugs on Market to Have E-ID by End of 2015
- SFDA Releases 3rd Batch of Illegal Drugs, Medical Devices and Health Food Advertisements in 2011
- SFDA issues Notice on Release and Delivery of GMP Certification Announcement - SFDA issues
- Notice concerning Circulation of the Administrative Measures on Drug Supervision in Medical Institutions
- Detailed Summary of SFDA 2010 Annual Report on Drug Registration and Approval… Continue Reading
On November 14, 2011, the Senate Health, Education, Labor and Pensions Committee held a hearing called "Medical Devices: Protecting Patients and Promoting Innovation." The hearing focused on the continued viability of a medical device clearance process that clears for market medical devices that are "substantially equivalent" devices to previously cleared devices (also known as the "510(k) process," in reference to the statutory provision governing this process). Class III medical devices not cleared through this process must undergo the more rigorous and time-consuming Premarket Approval process. Among the issues considered were whether the 510(k) process sufficiently evaluated the safety of devices when clinical data is not necessarily always considered or part of the submission; whether high-risk medical devices should always be considered for the 510(k) process; the user fees for medical device applications; strengthening post-approval monitoring requirements; and the resources and needs for the FDA and the Center of Devices and Radiological Health (CDRH) in reviewing, clearing and approving medical devices.… Continue Reading
The Centers for Medicare & Medicaid Services (CMS) has recently updated the information on its website with respect to the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA), Section 111 "Mandatory Insurer Reporting" requirements. The recent updates cover (1) a revised implementation timeline for certain liability insurance (including self-insurance) total payment obligation to claimant settlements, (2) revised guidance on claims involving exposure, ingestion, and implantation issues, (3) upcoming improvements to the Medicare Secondary Payer (MSP) program, (4) a new exception for certain settlements paid into a qualified settlement fund and (5) a new way for certain injured Medicare beneficiaries to satisfy their past and future MSP obligations.… Continue Reading
To implement the HITECH Act's mandate for the Office for Civil Rights (OCR) to perform HIPAA audits, OCR has just announced that it is piloting a program to perform up to 150 audits of covered entities to assess privacy and security compliance. Audits conducted during the pilot phase are planned to begin with an initial 20 audits between November 2011 and April 2012. The remaining audits are scheduled to conclude by December 2012. All covered entities and business associates are eligible for audits; however, OCR has indicated that it is focusing on covered entities (range in type and size) in the initial phase. Business associates will be included in future audits.… Continue Reading
