Katherine Wang

Katherine Wang

Ropes & Gray LLP

Contact  |  View Bio  |  RSS

Latest Publications

Share:

China Unveils Detailed Rules to Implement the Core Device Regulation

The amended Regulation for the Supervision and Administration of Medical Devices (the “Regulation,” also known as the State Council Order No. 650), which came into force on June 1, 2014, set the new framework for China’s...more

8/6/2014 - CFDA China FDA Medical Devices

China’s National Auditing Office Notes Compliance Concerns with Sponsorship of Academic Conferences in the Healthcare Sector

In China, it is common industry practice for pharmaceutical companies to sponsor academic conferences. As long as such events are aimed at enhancing the practice of medicine and patient welfare, the practice has been allowed....more

6/30/2014 - Audits China Healthcare Pharmaceutical Popular Sponsors

China Introduces Major Changes to Medical Device Regulations

On March 31, 2014, China’s State Council released the amended Regulations on the Supervision and Administration of Medical Devices (the “Regulations”), effective as of June 1, 2014. A series of implementing rules are expected...more

4/1/2014 - CFDA China Medical Devices

China Tightens Supervision and Enforcement in the Medical Device Sector

On March 13, 2014, the China Food and Drug Administration (the “CFDA”) announced an action plan titled “Rectifications of Five Common Types of Noncompliance Concerning Medical Devices” (the “Five Rectifications Campaign”). A...more

3/20/2014 - CFDA China Medical Devices

China Releases Fast Track Approval Process for Innovative Medical Devices

On February 7, 2014, the China Food and Drug Administration (“CFDA”) promulgated a notice titled The Fast Track Approval Process for Innovative Medical Device (Tentative), effective as of March 1, 2014. Unlike the draft...more

2/12/2014 - CFDA China Medical Devices

China Solicits Comments on Good Supply Practices for Medical Devices

The China Food and Drug Administration (the “CFDA”) recently published a draft regulation, Good Supply Practices for Medical Devices (the “Draft GSP”), for public comment through January 20, 2014. The first-ever regulation...more

1/10/2014 - China Compliance FDA Medical Devices Supply Chain Training

China Tightens Controls over Commercial Bribery in the Health Care Industry

As of March 1, 2014, the China National Health and Family Planning Commission (the “Commission”) will compile bribery blacklists in the health care industry from its provincial counterparts and publish such information on its...more

1/3/2014 - Bribery China Healthcare

China Expects Major Changes in Drug Registration and Contract Manufacturing Rules

The China Food and Drug Administration (“CFDA”) recently announced several draft rules, most notably, the Draft Amendment of the Provisions for Drug Registration (also known as the Drug Registration Rules, DRR) and the Draft...more

11/18/2013 - CFDA China Drug Manufacturers Pharmaceutical Prescription Drugs

China Releases Vaccine Good Clinical Practices

On October 31, 2013, The China Food and Drug Administration (“CFDA”) promulgated a regulation titled Guiding Principles for the Quality Management of Clinical Studies on Vaccines (“Vaccine GCP”), with immediate effect. The...more

11/8/2013 - CFDA China Clinical Trials Ethics Good Clinical Practices Medical Research Pharmaceutical Reporting Requirements Vaccinations

China Tightens Food Safety Administration

The Chinese State Council recently announced the draft amendment of the Food Safety Law (“Draft Amendment”) for public comments through November 29, 2013. A high priority initiative on the Chinese government’s agenda to...more

11/1/2013 - CFDA China Food Manufacturers Food Safety Penalties

China Solicits Comments on Post-Market Study Guidelines

The Center for Drug Evaluation (“CDE”) in China recently published the draft Guidelines for the Administration of Post-Market Studies on Chemical Drugs and Therapeutic Biologics (“Draft Guidelines”) for public comments...more

10/29/2013 - CFDA China Pharmaceutical Prescription Drugs

China Announces Master Plan for the Healthcare Services Industry

On September 28, 2013, China’s State Council published a plan titled Opinions on Promoting the Development of the Healthcare Services Industry, which outlines policy initiatives and development goals for China’s healthcare...more

10/17/2013 - China Healthcare

China Enhances Regulatory Oversight of Medical Device Studies and Vigilance

The China Food and Drug Administration (“CFDA”) recently introduced two important initiatives concerning medical devices. 1) The Tentative Rules on the Review and Approval of Medical Device Clinical Studies (Draft) was...more

10/15/2013 - China Medical Devices

China Solicits Comments on New Drug Technical Review Guidelines

The Center of Drug Evaluation (“CDE”) of the China Food and Drug Administration (“CFDA”) recently announced the Draft Guidelines for Clinical Evaluation of NDA/BLA Applications (“Draft Technical Review Guidelines”) for public...more

10/14/2013 - CFDA China Prescription Drugs

China Establishes Shanghai Free Trade Pilot Zone

Shortly after the approval for the Plans for the Shanghai Free Trade Pilot Zone (the “Shanghai FTZ”), the Standing Committee of China’s National People’s Congress published the first legislation on the Shanghai FTZ – the...more

9/24/2013 - China Free Trade Agreement Free Trade Zone

China Strengthens Control Over Infant Formula Production

In response to the discovery of toxic bacteria in products imported from a New Zealand dairy producer, the Chinese government has published a series of draft guidelines and regulations on infant formula production. These...more

8/21/2013 - China CMOs Food Manufacturers Food Safety New Regulations OEM

China Strengthens Oversight of Human Subjects Research

On July 15, 2013, China National Health and Family Planning Commission (the “Commission”) published the draft Administrative Measures on Medical Research Involving Human Subjects (the “Draft Measures”) and is seeking public...more

7/22/2013 - Animal Testing Biotechnology China Compliance Human Rights Medical Research Proposed Legislation

China Clarifies Requirements for Supplementary Information for Medical Device Evaluation

The Center for Medical Device Evaluation (the “CMDE”) recently clarified its requirements on supplementary information for medical device evaluation in connection with the registration of domestic Class III medical devices...more

5/28/2013 - China FDA Medical Devices Supplemental Information

China FDA Announces Key Appointments and Restructuring Plan

Following its recent re-elevation to the ministry level and the appointment of a new Commissioner in March, Mr. Yong Zhang, former Director of the Food Safety Office under the State Council of China, the China Food and Drug...more

5/21/2013 - Administrative Appointments China Restructuring SFDA

China FDA Publishes Draft Measures to Accelerate Medical Device Approvals

The China Food and Drug Administration (previously known as the State Food and Drug Administration) (the “CFDA”) has published drafts of two tentative measures, Fast Track Approval Process of Innovative Medical Devices and...more

3/26/2013 - Approval China Medical Devices

China Releases New Essential Drug List

China’s Ministry of Health released the new essential drug list (the “2012 EDL”) on March 15, 2013, effective as of May 1, 2013. Essential drugs are those which meet basic health care demands in suitable dosage forms with...more

3/22/2013 - China Essential Drug List Healthcare Pharmaceutical Prescription Drugs

China Clarifies Fast Track Approval Eligibility for Novel Biologics

The Chinese State Food and Drug Administration (“SFDA”) created a fast track review and approval process for novel drugs in its Drug Registration Rules issued in 2007. The fast track approval process is available for (1)...more

3/13/2013 - Biologics China Pharmaceutical Prescription Drugs SFDA

China SFDA Creates New Regulatory Pathways for Transfer of Drug Licenses

To accelerate GMP compliance by domestic pharmaceutical companies, the Chinese State Food and Drug Administration (“SFDA”) published a notice on February 22, 2013 (the “Notice”) clarifying the regulatory pathways for...more

3/4/2013 - China Drug Manufacturers Licenses Pharmaceutical SFDA

China Amended Good Supply Practices for Pharmaceuticals

The Chinese Ministry of Health (“MOH”) published the long-awaited amendment of Good Supply Practices for Pharmaceuticals (the “Amended GSP”) on January 22, 2013, to be effective as of June 1, 2013. After three rounds of...more

2/21/2013 - China Drug Manufacturers Drug Safety Good Supply Practices Ministry of Health Pharmaceutical Pharmaceutical Distribution

Chinese FDA Imposes Mandatory Electronic Barcoding on Imported Drugs

The State Food and Drug Administration (“SFDA”) issued a Notice on Relevant Issues Concerning Imposing Electronic Barcoding on Imported Drugs (“Notice”) on January 29, 2013 with immediate effect. Pursuant to the Notice,...more

2/5/2013 - China Drug Manufacturers Electronic Barcoding Imports Pharmacies Prescription Drugs SFDA

29 Results
|
View per page
Page: of 2