Katherine Wang

Katherine Wang

Ropes & Gray LLP

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China FDA Releases Guideline for Medical Device Registration Studies

On May 19, 2015, the China Food and Drug Administration (“CFDA”) unveiled the Technical Guideline Governing Medical Device Clinical Evaluation (“Guideline”). The long-awaited Guideline explains the methodology for clinical...more

5/26/2015 - CFDA China Medical Devices

China Liberalizes Drug Pricing Control

Beginning June 1, 2015, the vast majority drugs in China, except for narcotic and Type 1 psychotropic drugs, will be free from government-set pricing. This reform on drug pricing policy was announced by the central pricing...more

5/12/2015 - China NDRC Pharmaceutical Pharmaceutical Manufacturers

Chinese Legislature Adopts Amendments to Drug Administration Law

China’s top legislature, the Standing Committee of National People’s Congress, recently approved the amendments (the “Amendments”) to the Drug Administration Law. The Amendments, effective as of April 24, 2015, cover the...more

4/30/2015 - Amended Legislation China Pharmaceutical Prescription Drugs

China Announces Final Biosimilars Guideline

The Center for Drug Evaluation (the “CDE”) under the China Food and Drug Administration published final biosimilars guidance on February 28 with immediate effect. Officially titled the Technical Guideline for the Research,...more

3/6/2015 - Biosimilars China Final Guidance Pharmaceutical Pharmaceutical Manufacturers

China Announces Revised Good Clinical Practices for Public Comments

The China Food and Drug Administration (“CFDA”) recently released its proposed revisions to Good Clinical Practices (“GCP”) for pharmaceutical clinical studies for public comments. The proposed revisions, if eventually...more

2/13/2015 - CFDA China Clinical Laboratories Clinical Trials Pharmaceutical Pharmaceutical Manufacturers

China Introduces New Medical Device GMP and GSP Rules

In December 2014, China’s Food and Drug Administration (“CFDA”) revised the existing provisional Good Manufacturing Practices for medical devices (“New GMP”), and issued the country’s first Good Supply Practices for medical...more

1/8/2015 - CFDA China Manufacturers Medical Devices

China Issues Draft Guidance on Multi-Regional Clinical Trials

On November 21, 2014, China Food and Drug Administration (“CFDA”) released a Draft Guidance on Multi-Regional Clinical Trials (Provisional) (“Guidance”) for public comments through December 21. The Guidance aims to set forth...more

11/26/2014 - China Clinical Trials Pharmaceutical Public Comment

China Solicits Comments on Biosimilars Guideline

The Center for Drug Evaluation (“the CDE”) of the China Food and Drug Administration (“CFDA”) recently published a long-awaited guidance document for companies seeking to develop biosimilars. This document, titled Draft...more

11/5/2014 - Biosimilars CFDA China Public Comment

China Aims to Tighten Supervision Over Clinical Studies

China’s health authority, the National Health and Family Planning Commission (“NHFPC”), recently released the Administrative Measures for the Clinical Study Projects of Medical Institutions (“the Measures”) jointly with China...more

10/31/2014 - China Clinical Trials Regulatory Standards

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

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