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Pharmaceutical Industry › International Harmonization

Akin Gump Strauss Hauer & Feld LLP

US Seeks Comments on Text for WIPO Genetic Resources Treaty

Akin Gump Strauss Hauer & Feld LLP on

Summary - Last year the World Intellectual Property Organization (WIPO), under a threat of a vote, accelerated negotiations on an international legal instrument related to intellectual property (IP) and genetic resources...more

Goodwin

UK’s Medicines Regulator Announces Guidance on the New International Recognition Procedure for the Approval of New Medicines from...

Goodwin on

Earlier this year, the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), announced that a new International Recognition Procedure (IRP) will be put in place for the approval of new...more

Latham & Watkins LLP

Time to Prepare for New EU Medical Device Regime

Latham & Watkins LLP on

Companies should act now to prepare for the full implementation of the MDR and IVDR. On 26 May 2020, Regulation (EU) 2017/745 on medical devices (MDR) will become fully active, reflecting an overhaul of the current...more

Knobbe Martens

FDA Statement Regarding Quality Assurance Efforts for Foreign Drug Manufacturing Facilities

Knobbe Martens on

On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards. Currently, there are over 5,000...more

Jones Day

GCP Renovation ICH Reflection on "GCP Renovation"

Jones Day on

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH") has released a reflection paper on Good Clinical Practice ("GCP") "Renovation," which contains the ICH proposal...more

Goodwin

Brexit’s Impact on the Biosimilar Market

Goodwin on

The United Kingdom’s referendum in favor of withdrawal from the European Union, colloquially known as “Brexit,” has already sent shockwaves through the business world, both within the UK, and abroad. The impact of Brexit on...more

McGuireWoods LLP

International Council on Harmonisation (ICH) Includes International Generic and Biosimilars Trade Organization (IGBA) for the...

McGuireWoods LLP on

On June 15, 2016, the International Council for Harmonisation (ICH) (formerly the International Conference on Harmonisation) announced that the International Generic and Biosimilars Medicines Association (IGBA) could join ICH...more

McGuireWoods LLP

IGPA 2015 Focuses on Biosimilars, Quality, and Harmonization in Toronto-Part Two of Two

McGuireWoods LLP on

The following day features a panel of chief executive officers from a variety of pharmaceutical companies of different sizes and focus areas. Common themes included ongoing industry consolidation and increasing concern about...more

McGuireWoods LLP

IGPA 2015 Focuses on Biosimilars, Quality, and Harmonization in Toronto-Part One of Two

McGuireWoods LLP on

On September 16-18, 2015 the International Generic Pharmaceutical Alliance (IGPA) held its 18th Annual Meeting in Toronto, Canada. IGPA is composed of members: the Canadian Generic Pharmaceutical Association (CGPA-Canada),...more

McDermott Will & Emery

The New EU Clinical Trials Regulation Aims at Harmonization and Transparency

McDermott Will & Emery on

On June 16, 2014, Reg. (EU) No. 536/2014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes applicable, the Regulation will provide a comprehensive legal framework for...more

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