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By Huang Jianwen King & Wood Mallesons’ Commercial & Regulatory group

In order to deepen the reform in the field of drugs, the China Food and Drug Administration (“CFDA”) issued the Drugs Administration Law (Draft for Consultation) (“Draft”) on 23 October 2017. The Draft incorporates and reflects material contents in the reform of drugs field in recent years, including fully implementing the Marketing Authorization Holder (“MAH”) system, cancelling certificates of Good Manufacturing Practice (“GMP”) and Good Supply Practice (“GSP”), carrying out records management for clinical trial institution and emphasizing legal liabilities on relevant entities in drug research and trial.
Continue Reading Analysis on the Drugs Administration Law (Draft for Consultation)

By Huang Jianwen King & Wood Mallesons’Commercial & Regulatory Group

huang_jianwenOn July 25, 2016, the China Food and Drug Administration (“CFDA”) published the Administrative Provisions for Drug Registration (Revision) (the “Draft for Comment”) and submitted the Draft for Comment for public opinions.  Composing of 8 chapters and 147 provisions in total,…

By Shi Bisheng King & Wood Mallesons’ IP Group

In April 2015, the Legislative Affairs Office of the State Council P.R. China released the “Regulations on Service Inventions (Draft for Review)” (the “Regulations”) to the public for comment. The Regulations provide detailed provisions regarding the ownership of service inventions, the service invention reporting system, the…

By Susan Ning, Shan Lining, Ji Kailun and Liu Jia

 

On 25 April 2011, the Supreme People’s Court (the Court) published draft rules which govern Anti-Monopoly Law private actions (Draft Rules).  These draft rules are entitled "Provisions on Issues Concerning the Application of Law in relation to Trials of Monopoly Civil Dispute Cases".

 

This article outlines the salent provisions of, and points to some interesting features of, these Draft Rules.
Continue Reading A Further Look At The Draft Rules Governing AML Private Actions

By Susan Ning, Yin Ranran

On 25 April 2011, the Supreme People’s Court issued for public comments draft rules which govern civil action in relation to Anti-Monopoly Law (AML) disputes.  These rules are entitled "Provisions on Issues Concerning the Application of Law in the Trial of Monopoly Civil Dispute Cases"("Draft Rules").  Prior to the release of these Draft Rules, there haven’t been any detailed rules in relation to AML civil action.  The court will consult on this Draft Rules till 1 June 2011.

The Draft Rules contain 20 articles covering jurisdiction, standing of plaintiffs, burden of proof, evidentiary rules, relationship of antitrust administrative investigations and the judicial process, form of civil liabilities and the statute of limitations.  The objective of these Draft Rules is to ensure proper adjudication of civil monopoly disputes cases, prevent monopolistic conduct, protect fair competition in the market and safeguard the interests of consumers and public interest. Continue Reading Supreme People’s Court Issues Draft Rules Governing Private Actions under the Anti-Monopoly Law