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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Katherine Wang ordered by Published Date Descending.
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1
China's Legislature Passes The New Drug Administration Law
After almost two years of extensive review and deliberation, the Chinese legislature finally passed the new Drug Administration Law ("DAL") on August 26, 2019, which will go into effect on December 1, 2019.
United States
2 Sep 2019
2
China's Central Government Introduces Major Policy Incentives And Restraints To The MedTech Industry
After continuously reshaping the competitive landscape in the pharmaceutical industry for several years, the Chinese government finally shifted its attention to the medtech industry.
China
21 Aug 2019
3
China's State Council Publishes New Regulations On The Management Of Human Genetic Resources
China's State Council, the country's top administrative authority, released a new Regulation of Human Genetic Resources1 (the "Regulation") on May 28, 2019, to replace the tentative rules issued
China
26 Jun 2019
4
China Proposes Major Changes To Pharmaceutical Regulations
On April 20, 2019, the Chinese government submitted a second draft of the Drug Administration Law of the People's Republic of China to the Standing Committee of the NPC for deliberation.
China
30 May 2019
5
China Aims To Introduce Routine Drug And Device Overseas Inspections
China's drug and device regulator recently announced a set of rules signaling increased scrutiny of foreign drug and device companies.
China
18 Jan 2019
6
China's Health Authorities Issue New Rules on Telemedicine
The Measures clarify longstanding ambiguities regarding the scope of permitted telemedicine.
China
26 Sep 2018
7
The Impact Of Scientific Data Administrative Measures On Foreign Companies In China
On March 17, 2018, the Chinese State Council passed the Scientific Data Administrative Measures (the "Measures") to standardize the management of scientific data at a national level.
China
17 Aug 2018
8
China's New Medical Device Regulations Bring Big Changes
The current MDR requires medtech companies to either conduct clinical studies in China or submit clinical evaluation reports illustrating equivalence to previously approved products
China
31 Jul 2018
9
The China Drug Administration Proposes A Working Procedure For Pharmaceutical Study Data Protection
In response to the central government's calling for a data protection mechanism,1 the China Drug Administration (the "CDA") ...
China
9 May 2018
10
What Companies Need To Know About China's New Market Regulator
On March 17, China's highest legislative body, the National People's Congress, approved a sweeping government restructuring plan.
China
19 Apr 2018
11
China Announces New Initiatives To Level The Playing Field For Innovative And Generic Drugs
China's Government will launch several incentives to enhance accessibility of innovative drugs, especially imported oncology drugs.
China
17 Apr 2018
12
China's New State Market Regulatory Administration: What To Know And What To Expect
On March 17, China's highest legislative body, the National People's Congress, approved a sweeping government restructuring plan.
China
6 Apr 2018
13
China FDA Releases Guidance On Acceptance Of Foreign Medical Device Study Data
On January 10, 2018, the China Food and Drug Administration announced the implementation of the Technical Guidelines Governing Acceptance of Medical Device Clinical Data from Foreign Studies.
China
22 Jan 2018
14
China's FDA Reform Will Encourage Life Science Innovation
The opinions will create a level playground for R&D-focused drug and device companies, at home and abroad.
China
21 Nov 2017
15
China FDA's Device Regulations Ready For Public Comments
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.
China
2 Nov 2017
16
China FDA's Pharmaceutical Regulations Ready for Public Comments
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.
China
25 Oct 2017
17
China's Central Government Unveils Final Policy For Drug And Device Regulatory Reform
In addition, the Final Policy attempts to strike a balance between the potentially conflicting interest of innovative and generic drug manufacturers.
China
12 Oct 2017
18
China FDA Updates The Medical Device Classification Catalogue
In China, medical devices are divided into three regulatory classes based on the identified risks associated with the devices.
China
11 Sep 2017
19
China Announces Amendments to Regulation on the Supervision and Administration of Medical Devices
On May 19, 2017, China's State Council promulgated the amendments to the 2014 Regulation on the Supervision and Administration of Medical Devices ("the Amendments"), which became effective immediately.
China
25 May 2017
20
China FDA Calls For Comments On Key Policy Proposals
Further legislative initiatives will be arranged if any parts of the draft policies contradict the current CFDA regulations.
China
15 May 2017
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