Hien Thi Thu Vu

Head of Regulatory Affairs – Vietnam
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T: +84 24 3772 5606
F: +84 24 3772 5568

Practices

Office

Languages

Vietnamese, English

Education

LLB, Hanoi Law University

Bachelor of Pharmacy, Hanoi University of Pharmacy

Bachelor of English, Hanoi University of Foreign Language

Hien Thi Thu Vu heads the Tilleke & Gibbins regulatory affairs team in Vietnam, advising and assisting chemical, pharmaceutical, medical device, and biotechnology companies to register their products with Vietnam’s regulatory agencies. She also assists with analyzing technical matters and assessing the possibility of infringement in patent infringement cases.

In a region where generic drugs are increasingly promoted and given market access, Hien advocates for the rights of healthcare companies that devote extensive assets to R&D activities, and helps pharmaceutical companies to list their products in the original brand-name lists issued by the Drug Administration of Vietnam. She has a strong background in the life sciences, with a degree in pharmacy, two years of industry experience as a medical representative with Hoffman-La Roche, and 15 years as a patent executive.

Hien is a licensed attorney and a Vietnam-qualified IP agent, and previously headed the patent unit at a leading local firm in Hanoi.

  • Analyzed the patent claims, drafted claim charts, and obtained professional conclusions on patent infringement from the Vietnam Intellectual Research Institute in several patent infringement cases concerning patented human drugs.

  • Conducted a search and provided a freedom-to-operate opinion pertaining to a vaccine for pigs.

  • Prepared arguments/explanations to submit to the Drug Administration of Vietnam to successfully declare a biologic drug as an original brand-name drug, thereby allowing it to join drug tenders for original brand-name drugs in hospitals in Vietnam.

  • Advised two international pharmaceutical companies on issues of patent and data exclusivity in Vietnam in light of the Trans-Pacific Partnership.

  • Commented on and recommended changes in Vietnamese pharmaceutical legislation in light of the Trans-Pacific Partnership and EU-Vietnam Free Trade Agreement through a roadmap prepared for the government by the European Chamber of Commerce’s Pharma Group.

Datesort icon Title
January 8, 2018

Tilleke & Gibbins Credited by Chemlinked in Guide to Food Regulation in Vietnam

Hien Thi Thu Vu

Chemlinked has credited Tilleke & Gibbins as the lead contributor in its guide to food regulations in Vietnam. The guide forms part of Chemlinked's Foodpedia  tool, which provides a...

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December 12, 2017

Chambers Asia-Pacific 2018: Vietnam IP Practice Placed in Top Tier

Tilleke & Gibbins’ Intellectual Property practice was ranked in Band 1 in Vietnam in the 2018 edition of Chambers Asia-Pacific. This is the 10th consecutive year the firm has achieved this top-...

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November 30, 2017

Legal 500 Asia Pacific 2018: Tilleke & Gibbins Ranked in Tier 1 for IP and Labor in Vietnam

Tilleke & Gibbins stands alone at the top of the field in Intellectual Property (International Firms) in Vietnam, according to the latest rankings from The Legal 500 Asia Pacific. The highly...

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November 29, 2017

Tilleke & Gibbins Wins Three Asialaw Firm of the Year Awards

Tilleke & Gibbins has received high accolades for its exceptional regional practice at the inaugural Asialaw Asia-Pacific Legal Practice Awards, where it was named Southeast Asia Firm of the Year...

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November 15, 2017

Tilleke & Gibbins Vietnam has Strong Showing in Asialaw Profiles 2018

In the 2018 edition of Asialaw Profiles, Tilleke & Gibbins was recognized as a leading law firm in Vietnam in seven practice areas, as follows: Outstanding: Intellectual Property; IT, Telco...

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Datesort icon Title
January 8, 2018

APFI Food Safety Regulations Series: Vietnam

Hien Thi Thu Vu

To better understand the food regulatory landscape in Asia, APFI has spoken to law firms that specialize in food law from five different countries across Asia, which include China, Thailand, Vietnam...

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December 22, 2017

New Guidance Released on Class B, C, and D Medical Devices in Vietnam

Hien Thi Thu Vu, Thomas J. Treutler

Vietnam’s Ministry of Health (MOH) has recently issued a very important notification and new regulations relating to the implementation of Decree No. 36/2017/ND-CP (Decree 36) on medical device...

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December 20, 2017

Vietnam Pharma Update 2017

Tilleke & Gibbins’ fourth annual Vietnam Pharma Update  provides a compilation of articles on the life sciences sector in Vietnam written by our lawyers, IP executives, and regulatory...

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September 22, 2017

PLC Life Sciences Global Guide 2017 – Vietnam Chapter

Hien Thi Thu Vu, Tu Ngoc Trinh

Pharmaceutical experts from Tilleke & Gibbins authored the Vietnam chapters of the latest edition of the PLC Life Sciences Global Guide. PLC’s popular guides provide a comparative overview, in Q...

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February 27, 2017

PLC Agricultural Law Global Guide 2017 – Vietnam Chapter

Kien Trung Trinh, Hien Thi Thu Vu, Linh Duy Mai

The latest edition of Practical Law Company’s Agricultural Law Global Guide  was recently published, with the Vietnam chapter written by lawyers from Tilleke & Gibbins. The guide’s Q&A...

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