Katherine Wang

Katherine Wang

Ropes & Gray LLP

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China's Medical Device Market: Coping with Evolving Regulatory Challenges

Ask a senior manager of a MedTech company in China what keeps her or him awake at night and “regulatory changes” will invariably be among the first things mentioned. In fact, in McKinsey’s 2016 survey of MedTech CEOs,...more

8/4/2016 - China China FDA Clinical Trials Manufacturers Medical Devices Regulatory Standards Technology Sector

China's Medical Device Market: Coping with Evolving Regulatory Challenges

Ask a senior manager of a MedTech company in China what keeps her or him awake at night and “regulatory changes” will invariably be among the first things mentioned. In fact, in McKinsey’s 2016 survey of MedTech CEOs,...more

8/4/2016 - China China FDA Clinical Trials Manufacturers Medical Devices Regulatory Standards Technology Sector

CFDA Solicits Comments on Drug Registration Rules

The China Food and Drug Administration (“CFDA”) recently published long-awaited and comprehensive revisions (“Revisions”) to the Drug Registration Rules (“DRR”). The Revisions are now open to public comments until August 26,...more

8/2/2016 - China China FDA Clinical Trials Comment Period Pharmaceutical Industry Research and Development

China FDA Solicits Comments on Priority Review Designation Procedure for Devices

The China Food and Drug Administration (“CFDA”) recently proposed a draft circular to address the priority review designation issue for medical devices, namely the Circular Regarding Soliciting Comments Regarding Priority...more

6/28/2016 - China China FDA Medical Devices Pharmaceutical Industry Research and Development

China Announces a Detailed Pilot Plan for the Marketing Authorization Holder System for Drugs in Selected Regions

China’s State Council announced on May 26, 2016, a detailed pilot plan for the Marketing Authorization Holder System (“MAH”) for drugs in 10 provinces in China (the “Plan”). The three-year pilot program was initiated in...more

6/15/2016 - China Marketing Pharmaceutical Industry Research and Development

China FDA Announces Good Clinical Practices for Medical Devices

On March 23, 2016, the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission jointly promulgated the final revision to the 2004 Medical Device Clinical Studies Rules (“MDCSR”), the...more

3/28/2016 - CFDA China Clinical Trials Medical Devices Pharmaceutical Industry Standards & Procedures

China FDA Launches a New Classification System for Registration of Chemical Drugs

China FDA formally launched a new classification system for chemical drugs, with the release of the Reform Scheme of the Classification System for Registration of Chemical Drugs (“Reform Scheme”) on March 4, 2016. The Reform...more

3/14/2016 - China Classification Generic Drugs Pharmaceutical Industry Prescription Drugs

China FDA Announces Implementation Scheme to Improve the Drug Approval System

Following the reform of the drug and device approval system by China’s State Council in August,1 the China Food and Drug Administration (“CFDA”) has finally unveiled its implementation policies regarding improvements to the...more

11/19/2015 - China Drug Approvals Generic Drugs Prescription Drugs

China’s State Council Announces Reform on the Drug and Device Approval System

China will launch new reforms of its current review and approval system for drugs and medical devices, announced by China’s State Council, in its August 18, 2015, circular Opinions Concerning the Reform of the Review and...more

8/21/2015 - China China FDA Clinical Trials Healthcare Life Sciences Medical Devices Pharmaceutical Industry Research and Development

China's Medical Device Market: New Policies, Higher Stakes

The recent introduction of the Regulations on the Supervision and Administration of Medical Devices (also known as State Council Order 650) has created significant impact in the medical device industry in China. The changes...more

8/19/2015 - China Healthcare Manufacturers Medical Devices New Regulations Regulatory Standards

China FDA Solicits Comments on Resolving the Backlog of Drug Applications

The China Food and Drug Administration (“CFDA”) recently published a draft circular to address the backlog of drug applications. The Circular Regarding Several Draft Policy Opinions to Accelerate the Resolution of the Backlog...more

8/7/2015 - CFDA China Comment Period Generic Drugs Pharmaceutical Industry Prescription Drugs

China Tightens Advertising Rules for Life Sciences Companies

This year China’s Advertising Law will see its first amendment in two decades. The amendment, which will be implemented on September 1, 2015, reflects the central government’s efforts to strengthen consumer protection and to...more

7/20/2015 - Advertising China Life Sciences Medical Devices Pharmaceutical Industry SAIC

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 Industry

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 Industry 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 Industry

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 Industry

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 Industry 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 Industry 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

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