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DeHeng Law Offices
新冠肺炎疫情爆发以来,...
DeHeng Law Offices
疫情下药品进口法律法规简析
DeHeng Law Offices
2020年1月30日,国家卫健委疾病预防控制局发布《预防新型冠状病毒感染的肺炎口罩使用指南》,明确口罩是预防呼吸道传染病的重要防线,可以ƀ
DeHeng Law Offices
随着新型冠状病毒肺炎疫情(以下简称"肺炎疫情")...
DeHeng Law Offices
新冠疫情肆虐,...
DeHeng Law Offices
自新型冠状病毒感染的疫情发生以来...
DeHeng Law Offices
春节期间,一家电商企业发来一份商品销售清单,询问销售清单中的商品是否需要办理相关资质、是否可以直接销售等问题。清单所列商品主#
Kangxin
The opportunity to decide writing this article is a startling photo that pop into my eyes when searching the meaning of the word "thalidomide" on the Internet.
DeHeng Law Offices
近几个月来医疗器械行业内改革动作频频。医疗器械注册人制度试点扩大到21个省,有如释放行业创新活力的一剂良方,监管方通过将产研分开&#
Ropes & Gray LLP
After continuously reshaping the competitive landscape in the pharmaceutical industry for several years, the Chinese government finally shifted its attention to the medtech industry.
Ropes & Gray LLP
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
Hogan Lovells
T he past year is set to be a milestone year for China's pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red
European Union
Singh & Associates
These cells are central to many blood cancers, including common forms of lymphoma and leukaemia.
Singh & Associates
On February 28, 2019, European Medicine Agency published the first guidance on new rules for certain medical devices - the first of a series of guidance documents to help applicants to prepare for compliance with these new rules.
Hong Kong
Global Advertising Lawyers Alliance (GALA)
Mind your spice products - ? contain Carcinogens. Dried spices can contain aflatoxins (AFs) or ochratoxin A (OTA) or both.
India
SKP Business Consulting LLP
On 11 February 2020, the Government of India issued a notification declaring that all medical devices are to be classified as drugs from 1 April 2020 under the Drugs and Cosmetics Act, 1940.
Singh & Associates
On January 16, 2020, Indian Council of Medical Research announced a significant development that the WHO Global TB Programme has included an Indian Molecular assay...
Singh & Associates
The Central Drugs Standard Control Organization (CDSCO), New Delhi, under the aegis of the Ministry of Health ...
Nishith Desai Associates
While there has been some significant development in the healthcare sector (specifically in the area of regulating doctors), medical devices sector has clearly witnessed the largest number of developments this year.
Nishith Desai Associates
The Ministry of Health and Family Welfare has released two draft notifications to regulate all medical devices in India under the Medical Device Rules, 2017.
Singh & Associates
This segment discusses the recent drug approvals from the US FDA in various severe diseases. The write-ups describe the role of a new drug in the treatment of serious conditions such as myeloma
SKP Business Consulting LLP
Access to quality healthcare is a fundamental need of a country's citizens and lays the foundation for sustainable and equitable economic development
Cyril Amarchand Mangaldas
Gujarat has been the flag bearer of India's pharmaceutical industry since the establishment of the country's second oldest drug company
Nishith Desai Associates
Regulation of medical devices has speedily evolved in the preceding two years. Before the introduction of the Medical Device Rules, 2017 ("MDR 2017"), the regulation of medical devices
Obhan & Associates
Evidence from DNA fingerprinting tests can be used to determine disputes involving plant varieties, according to a recent decision of the Delhi High Court. In its recent judgment
AZB & Partners
Some authorities have issued separate handbooks in the context of the leased lands, which impose additional restrictions as well.
AZB & Partners
On May 22, 2019, CCI approved the merger of certain consumer healthcare products of GlaxoSmithKline Plc. (‘GSK') and Pfizer Inc. (‘Pfizer', together with GSK
LexOrbis
Substances used for in vitro diagnosis, medical device, mechanical contraceptives, disinfectants and insecticides and other notified devices in India are now regulated by the Medical Device Rules, 2017...
LexOrbis
India released the draft regulatory guidelines for ‘Similar Biologics' at the BIO industry conference in Boston, USA, on 19 June 2012.
Nishith Desai Associates
SBI (through its investment vehicles in Japan and Singapore), Beenext, along with other investors led the Series B investment of approx. USD 17 million
Singh & Associates
On April 23, 2019, Indian Council of Medical Research (ICMR) licensed the technology for Shigella vaccine for further scaling up and commercialisation to MSD Wellcome Trust Hilleman Laboratories Pvt Ltd.
Nishith Desai Associates
January 01, 2019 marked the first anniversary of the Medical Device Rules 2017 – India's first step in de-linking medical devices regulations from drugs.
Singh & Associates
This is the first and only treatment for nraxSpA approved by USFDA.
Singh & Associates
Reported draft notification on revised Rules is based on recommendations of a panel set up by the ministry on August 04, 2018.
Cyril Amarchand Mangaldas
India is currently facing a declining fertility rate and a changing social structure, with late marriages and single parenthood becoming more common.
Singh & Associates
In February 2019, the Government of India introduced first draft regulatory guidelines for evaluation of nanopharmaceutical products for therapeutic use in the country.
Singh & Associates
Central Government, in order to enhance the safety of the cosmetic products, has proposed the product composition details clause shall be mentioned in the approval issued by the licensing authority in the country.
Singh & Associates
On February 15, 2019, the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers issued six draft QCOs, after consulting with the Bureau of Indian Standards to ensure safety and effectiveness of these medical devices:
Singh & Associates
On February 08, 2019, the Central Government announced that all Implantable Medical Devices along with CT scan Equipment, MRI Equipment, Defibrillators, Dialysis Machine, PET Equipment, X-Ray Machine, and ...
LexOrbis
When Stanley N. Cohen of Stanford and Herbert W. Boyer obtained a US patent in 1980 for the process for joining and replicating DNA from different species little they realized that they are ushering the era of Recombinant revolution for the entry of biologics as potential drugs or organic food products.
S.S. Rana & Co. Advocates
The Act and the Rules have been amended several times since coming into force to meet the need of the hour.
Singh & Associates
The Delhi High Court, on January 01, 2019, set aside the Central Government's ban on Wockhardt's anti-inflammatory medicine ‘Ace Proxyvon', a Fixed Dose combination of Aceclofenac 100 mg, Paracetamol 325 mg ...
Singh & Associates
The Central Government, with an aim to offer medicines/healthcare products at affordable prices to the public, has taken a number of measures ranging from making drugs available through Jan Aushadhi stores ...
Singh & Associates
In a landmark decision, the Lok Sabha, on January 08, 2019, passed the "DNA Technology (Use and Application) Regulation Bill - 20193" (here after referred as "Bill").
Nishith Desai Associates
The Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals) has notified an order amending the Drugs (Prices Control) Order 2013.
Japan
Hogan Lovells
It's been five years since both the name and the content of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the "Act")
Kazakhstan
GRATA International
The new rules for regulating the prices of medicines ('Price Regulation Rules 2019') were adopted in April 2019. Over the past five years, this is the third regulatory legal act establishing
Legalmax
The co-defendants in the case were Defendant, the Center for Expertise and the Pharmacy Committee.
New Zealand
Duncan Cotterill
The Biosecurity Act is to be reviewed partly as a result of flaws highlighted because of the Mycoplasma bovis outbreak.
Singapore
Global Advertising Lawyers Alliance (GALA)
In Singapore, it is illegal to sell and supply products which contain undeclared potent medicinal ingredients.
RHTLaw Taylor Wessing
The Healthcare and Life Sciences industry is one of the largest and dynamic industries in Singapore. Partner and Head of Healthcare & Life Sciences, Erwan Barre, shares how our Healthcare ...
TMF Group
数字化技术正在不断改变全球生物医药行业的形态:大数据与生物医药产业深度融合,人工智能对精准医疗不断探索,非传统医疗企业也纷纷
Taiwan
Saint Island International Patent & Law Offices
Medical devices had long been regulated under the Pharmaceutical Affairs Act as an incidental part of drugs. With the rapid growth of domestic medical device industry, this practice was increasingly criticized as being out of date.
Vietnam
Duane Morris LLP
Any pharmaceutical product not being made in Indonesia must obtain a compulsory license, according to a recent new regulation adopted in Jakarta.
Worldwide
Morrison & Foerster LLP
Partner Janet Xiao, who leads the firm's China Life Sciences Group, co-authored an article with associate Can Cui for Intellectual Property Magazine, ...
DLA Piper
The Therapeutic Goods Administration (TGA) has published a consultation paper seeking feedback on whether it should make excipient ingredients
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