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Clinical Trials Pharmaceutical Industry China

Hogan Lovells

Top legal issues to think about in China-related licensing transactions

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This article provides a general overview of certain Chinese legal considerations for licensing and collaboration deals in the life sciences industry. In particular, this article focuses on two types of transactions...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Hogan Lovells

China's draft implementation rules on human genetic resources: potential changes on HGR Supervision?

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The Ministry of Science and Technology of China has finally issued the draft of Implementation Rules for the Regulations of Human Genetic Resources Administration for public comments on March 21, 2022, which gives more...more

Morgan Lewis

China Amends Regulation Governing Medical Devices

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China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on...more

Goodwin

Everest Medicines Announces Approval of Clinical Trial Application by China National Medical Products Administration for Phase 3...

Goodwin on

On January 6, 2021, Everest Medicines (HKEX 1952.HK) announced that the National Medical Products Administration (NMPA) of the People’s Republic of China approved a Clinical Trial Application (CTA) for sacituzumab...more

Hogan Lovells

AIFA provides guidance on critical aspects relating to the management of clinical trials in Italy during the COVID-19 emergency

Hogan Lovells on

Due to the COVID-19 emergency and the consequent lockdown that is affecting non-essential services in Italy, including some health care services, on March 12, 2020 the Italian Medicines Agency ("AIFA") issued a Guidance,...more

Morgan Lewis

Potential Impact of Coronavirus (COVID-19) on the Pharmaceutical and Biotech Industries

Morgan Lewis on

The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more

Morgan Lewis

Overview of Medical Device Regulation in China

Morgan Lewis on

How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and...more

Goodwin

Biosimilar and Biologic Updates in China: Bevacizumab, Etanercept, Tislezumab, Infliximab, Eculizumab, Adalimumab

Goodwin on

The past few weeks have seen the following biosimilar developments in China: ..On December 16, 2019, Qilu Pharmaceutical received approval in China for ANKADA, a biosimilar to AVASTIN (bevacizumab). ANKADA has been...more

Hogan Lovells

China adds 30 drugs to its "urgently needed" list

Hogan Lovells on

Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications - On 28 March China's National Medical Products Administration (NMPA) published a list of an...more

Morgan Lewis

China National Drug Administration Sets Guidelines for Overseas Drug Trial Data

Morgan Lewis on

In an effort to increase the availability of pharmaceutical treatments in China, the China National Drug Administration has recently released guidelines to allow pharmaceutical drugs that have already undergone clinical...more

Knobbe Martens

China Drug Administration Proposes Pharmaceutical Data Protection Guidelines

Knobbe Martens on

On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...more

Hogan Lovells

China Drug Administration publishes a key Draft Guidance on data exclusivity

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This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more

Cooley LLP

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

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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

Goodwin

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

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

Goodwin

Alteogen Reportedly Transferring Biosimilar to Qilu Pharmaceutical

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

K&L Gates LLP

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

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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

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