Search Results for TPP

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Researchers Link Target Product Profiles to Shorter Review Times By Michael Mezher - Published 17 April 2017

A recent analysis finds that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Labeling, Quality, Regulatory strategy, Submission and registration

Tags: Target Product Profile, TPP, Quality Target Product Profile, QTPP

TPP, WTO Deals Reveal Strength of Pharma Industry’s Negotiating Power By Zachary Brennan - Published 06 November 2015

After five years of negotiations, the release of the final text of the long-awaited trade deal, known as the Trans-Pacific Partnership (TPP), on Thursday, as well as concessions made to the US in the WTO’s TRIPS (trade-related aspects of intellectual property rights) deal announced Friday both offer new insight into the strength of the pharmaceutical industry’s lobbying and negotiating powers.

Categories: News, Africa, Asia, Canada, Europe, Middle East, Oceania, US, EC, MHLW, PMDA, TGA, Drugs, Government affairs, Manufacturing, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: TPP, TRIPS, WTO, least-developed countries, medicines access, KEI, MSF, trade deals, biologics exclusivity

Leaked TPP Chapter on IP Sets Terms of Biologics Data Exclusivity By Zachary Brennan - Published 09 October 2015

Information on biologics data exclusivity provisions in the Trans-Pacific Partnership remains murky, despite a leaked copy of the final version of the TPP Chapter on Intellectual Property rights from WikiLeaks on Friday.

Categories: News, Asia, Canada, US, Biologics and biotechnology, Compliance, Drugs, Reimbursement, Submission and registration

Tags: TPP, WikiLeaks, Assange, biologics exclusivity, market exclusivity

Final TPP Agreement Draws Ire from Both Sides over Biologics Exclusivity By Zachary Brennan - Published 05 October 2015

Pharmaceutical industry groups and nonprofits expressed disappointment Monday over a compromise in the Trans-Pacific Partnership (TPP) on biologics data exclusivity.

Categories: News, Asia, Canada, Oceania, US, Biologics and biotechnology, Distribution, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: TPP, Trans-Pacific Partnership, biologics exclusivity, BIO, PhRMA, MSF

Biologics Exclusivity Still Central in Trade Talk Debate By Michael Mezher - Published 05 June 2015

The length of data exclusivity for biologics remains one of the most controversial aspects of the Trans-Pacific Partnership (TPP), which is poised to be the largest free-trade deal in history.

Categories: News, Asia, Canada, Latin America and Caribbean, Oceania, US, Biologics and biotechnology, Government affairs, Regulatory strategy

Tags: Trans-Pacific Partnership, TPP, biologics exclusivity, regulatory data protection, PhRMA, intellectual property, IP, patents

Trade Talks Stumble Over Biologics Data Exclusivity By Michael Mezher - Published 11 February 2015

Trade officials from around the world are potentially just months away from completing what would be the largest free-trade deal in history, but the completion of that deal is reportedly struggling to get past an issue related to the regulation of biologics.

Categories: Japan, Canada, Latin America and Caribbean, Oceania, US, Biologics and biotechnology, Government affairs, Regulatory strategy

Tags: Trans-Pacific Partnership, TPP, intellectual property, patents, regulatory data protection, data exclusivity, USTR, Michael Froman

Data Exclusivity for Biologics at Forefront of International Trade Agreement Negotiations By Alexander Gaffney - Published 08 October 2012

Tags: Trade Agreement, TPP, Data Exclusivity, Obama Administration, White House, Obamacare, Latest News, PPACA, Biosimilars, Biologics