News & Analysis as of

China Pharmaceutical Industry

Antitrust, Competition and Economic Regulation Quarterly Newsletter - Autumn 2017

by Hogan Lovells on

First come, first served. That’s not the principle behind the clearance of Bitcoin transactions. Equally for other blockchain technology networks, the relevant factor to get a transaction on the next available block is not...more

China FDA’s Device Regulations Ready for Public Comments

by Ropes & Gray LLP on

The China Food and Drug Administration (CFDA) has published its proposed amendment of the Medical Device Regulations (MDR), previously known as the State Council Order # 650, for public comments. This Alert summarizes the key...more

China FDA’s Pharmaceutical Regulations Ready for Public Comments

by Ropes & Gray LLP on

The China Food and Drug Administration (CFDA) published its proposed amendment of the Drug Administration Law (DAL) and the Drug Registration Rules (DRR) for public comments. This Alert summarizes the key changes....more

Alert: China Issues New Policy for Drug and Medical Device Approvals

by Cooley LLP on

On October 8, 2017, the General Office of the CPC Central Committee and the General Office of China's State Council jointly issued Opinions of the State Council on Promulgating the Reform of Review and Approval System for...more

Shanghai Tightens Industry Interactions with HCPs

by Ropes & Gray LLP on

In August 2017, multiple departments of Shanghai government, led by Shanghai’s Health and Family Planning Commission (“Shanghai HFPC”), jointly issued a series of administrative rules (collectively, “Recent Shanghai Rules”)...more

China’s Central Government Unveils Final Policy for Drug and Device Regulatory Reform

by Ropes & Gray LLP on

Based on the CFDA’s policy proposals published in May 2017, China’s central government announced its final policy for drug and device regulatory reform on October 8, 2017 (“Final Policy”). The Final Policy reiterates the...more

The life sciences industry under the antitrust spotlight in China: two practical points

by Hogan Lovells on

The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement...more

China FDA Updates the Medical Device Classification Catalogue

by Ropes & Gray LLP on

On August 31, 2017, the China Food and Drug Administration (“CFDA”) announced the final revision to the 2002 Medical Device Classification Catalogue (“2002 Catalogue”). The revised version (“New Catalogue”), which will become...more

China proposes new rules to address perceived anti-competitive practices in the pharmaceutical industry

by Hogan Lovells on

On 14 August 2017, the National Development and Reform Commission ("NDRC") released a draft of the Guidelines on Pricing Conduct by Business Operators for Drugs in Shortage and Active Pharmaceutical Ingredients ("Draft...more

Major IP reforms foreshadowed in China’s Pharma sector

by Hogan Lovells on

On 12 May 2017, the Chinese Food and Drug Administration (the “CFDA”) issued several draft policies aimed at overhauling of the current regulations governing the Chinese pharma and medical device sector (the “Draft...more

China FDA Proposes Hatch-Waxman-Like Regulatory Framework Linking Drug Approval to Patent Rights

Recently, the China Food and Drug Administration (CFDA) issued a policy proposal linking drug approval to patent rights.1 The proposal is intended to promote innovation in the development of both drugs and medical devices and...more

CFDA’s New Draft Policy Introduces the Chinese Version of Patent Linkage

by Allen & Overy LLP on

On May 12, Chinese Food and Drug Administration (CFDA) issued Policy Notice No. 55, entitled “Policies Relevant to the Protection of the Rights and Interests of Innovators for the Encouragement of Innovation in Drugs and...more

China FDA Calls for Comments on Key Policy Proposals

by Ropes & Gray LLP on

On May 11-12, 2017, the China FDA (CFDA) issued four new draft policies for public comments, proposing further reforms in the current drug and medical device regulatory regime. The four draft policies aim to accelerate the...more

USTR Report Highlights Foreign Barriers to U.S. Exports

by Polsinelli on

U.S. companies should review a recent USTR (United States Trade Representative) report providing insight into the various country-specific issues that may take center stage in future trade negotiations. Companies should then...more

Generic consistency evaluation in China: the coming paradigm shift in drug pricing and patent cliff

by Allen & Overy LLP on

China is one of the largest generic drug markets in the world. As part of the drug approval reform, the ongoing generic consistency evaluation (GCE) is likely to have significant, long-lasting impacts on the market landscape,...more

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

A Chinese healthcare boom

by Hogan Lovells on

Presenting a tremendous potential for growth fueled by domestic demographic and economic forces, China's healthcare industry has attracted notable PE investments in recent years. And with some commentators projecting that...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

Importance of patents in Chinese pharmaceutical tendering

by Allen & Overy LLP on

China has a complicated and unique tendering system for drugs – and patents play an important role in almost every tender. What adds to the complexity is that tendering rules vary between provinces. Providing necessary patent...more

Antitrust, Competition and Economic Regulation Quarterly Newsletter - Winter 2017

by Hogan Lovells on

FTC takes another look at merger remedies - On 3 February 2017, the U.S. Federal Trade Commission (“FTC”) released its Merger Remedies Study, which analyzed the success of merger remedies imposed by the FTC from 2006 to...more

China’s State Council Announces Major Policies to Reform the Pharmaceutical Industry

by Ropes & Gray LLP on

China will launch further reforms in the pharmaceutical sector as part of the healthcare reform initiatives announced by the State Council in its February 9, 2017 Circular on Several Opinions Concerning Further Reforms of the...more

Boletín Mensual de Comercio Internacional: Enero - Información con Énfasis en la Regulación Comercial y de Arbitraje Internacional

by Holland & Knight LLP on

Durante el mes de Enero destacan los siguientes temas: Acceso, Compras, Propiedad Intelectual, Comercio, Inversión, Solución de Diferencias, Competencia, Subvenciones, Arbitraje Inversión....more

China Solicits Comments on Drug GCP

by Ropes & Gray LLP on

The China Food and Drug Administration (“CFDA”) recently proposed revisions to the Good Clinical Practices for Pharmaceuticals (“GCP”), the most comprehensive revision in 13 years. The revisions (“Revisions”) are now open to...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

A new trading link dropping next week will give international investors access to more than 800 stocks listed on China’s Shenzhen stock market, the boom/bust venue best known for its “rampant speculation”....more

Top Ten International Anti-Corruption Developments for October 2016

by Morrison & Foerster LLP on

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

135 Results
|
View per page
Page: of 6
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.