News & Analysis as of

Clinical Trials China

China’s FDA Accepts JHL Biotech’s Clinical Trial Application for Rituximab Biosimilar in NHL

by Goodwin on

JHL Biotech announced today that China’s FDA has accepted its application for the use of JHL1101 in Phase 1 and Phase 3 clinical trials in non-Hodgkin’s lymphoma patients. JHL1101 is a rituximab biosimilar candidate that JHL...more

Alteogen Reportedly Transferring Biosimilar to Qilu Pharmaceutical

by Goodwin on

Korean Biomedical Review is reporting that Alteogen will transfer technology related to its ALT-L2, a biosimilar of Herceptin, to Qilu Pharmaceutical of China. According to the article, Alteogen and Qilu will “jointly...more

China FDA Clarifies Legal Consequences of Clinical Trial Data Inspections

by Ropes & Gray LLP on

China’s recent drug regulatory reform has emphasized that clinical trial data must be authentic and reliable. However, the legal consequences for breaching data integrity requirements in clinical trials remain ambiguous. On...more

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

by Ropes & Gray LLP on

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

Keeping Up To Date On CRISPR – July 2016

by Foley & Lardner LLP on

CRISPR is a gene editing technique that promises to revolutionize genetic engineering, but already is raising ethical, business, and legal issues. This is the first in a monthly series of articles on CRISPR. ...more

CFDA Solicits Comments on Drug Registration Rules

by Ropes & Gray LLP on

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

China Issues First Update to Medical Device Clinical Trial Guidelines in 12 Years

The Chinese Food and Drug Administration (“CFDA”) recently announced its first update to the medical device clinical trial guidelines in 12 years. The finalized revision to the 2004 Medical Device Clinical Studies Rules...more

China FDA Announces Good Clinical Practices for Medical Devices

by Ropes & Gray LLP on

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

Alert: China Food and Drug Administration Offers Guidance on Clinical Trial Exemptions for Medical Devices

by Cooley LLP on

The "Administrative Measures for the Registration of Medical Device" (Registration Measures) was issued by the China Food and Drug Administration (CFDA) and became effective on October 1, 2014. According to the Registration...more

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

by Ropes & Gray LLP on

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

China Announces Revised Good Clinical Practices for Public Comments

by Ropes & Gray LLP on

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

China Issues Draft Guidance on Multi-Regional Clinical Trials

by Ropes & Gray LLP on

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

China Aims to Tighten Supervision Over Clinical Studies

by Ropes & Gray LLP on

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

Global Food, Drugs, Medical Devices and Cosmetics Newsletter - 3rd Edition

by K&L Gates LLP on

Welcome - We are pleased to provide you with the Fall edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. This newsletter provides updates on important issues and developments across these...more

China Amends Key Medical Device Regulations

by K&L Gates LLP on

The State Council of China passed amendments to the Regulations on Supervision and Administration of Medical Devices which came into effect on June 1, 2014. The amendments present significant regulatory changes that will...more

China Releases Vaccine Good Clinical Practices

by Ropes & Gray LLP on

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

Chinese FDA Unveils Plan for Regulatory Reform

by Ropes & Gray LLP on

The Chinese State Food and Drug Administration (“SFDA”) announced a plan for regulatory reform (“Reform Plan”) and is soliciting public comments through January 15, 2013. The Reform Plan sets forth the following key strategic...more

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