Three dimensional map of South Korea in South Korean flag colors.

South Korea – MFDS’ Major Pharmaceutical Policy Initiatives for 2017

The Ministry of Food and Drug Safety of Korea (the “MFDS“) announced major policy initiatives in the pharmaceutical sector for 2017 on January 9, 2017 (the “Policy Initiative”) With respect to pharmaceuticals, the MFDS declared plans to select the “Enhancement of the Safety Management System” as its main priority and thereby strengthen user-centered safety management as […]

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Portugal: Changes in the legal framework of advertising of medicines and medical devices

Rules that govern advertising and promotion activities of medicines and medical devices in Portugal have been changed recently by the enactment of Decree-Law 5/2017 of 6 January (“Decree-Law 5/2017”). This new legal act establishes principles that shall be accomplished by marketing authorization holders and distributors of medicines, as well as manufacturers and distributors of medical […]

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Sweden Reviews Financing and Pricing

In mid-November 2016 the government issued directives to review the pricing and reimbursement system and the national financing system for medicinal products. The government declared that the existing system is complex and complicated and must be improved in order to operate a modern healthcare system. Among other things, the review seeks to find a clear […]

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FDA

FDA Announces New Draft Guidances on Medical Product Communications (FDAMA 114)

18 January 2017 – the FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products.  These draft guidance documents provide clarity on FDAs position based on the […]

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French Sunshine Obligations Clarified and Extended

The long-awaited decree that clarifies the French “Sunshine” obligations was recently published in the French Official Gazette, and it brings about some important changes to the existing transparency requirements that apply in the life sciences sector in France. Indeed, pursuant to French Decree no. 2016-1939 of December 28, 2016 (“Sunshine Regulations”), health care companies (“HCCs”) […]

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ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6

ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) “Renovation”, which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the proposed renovation includes the current E8 General Considerations for Clinical Trials and further […]

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Deadline Alarm Clock

21st Century Cures Act— 11 February 2017 = Deadline for Company Disclosure of Expanded Access Programs

The landmark 21st Century Cures Act[1] (“Cures Act”), which was signed into law by President Obama and became effective on December 13, 2016 (“Enactment Date”), imposes a deadline by which the manufacturer or distributor of an investigational drug for the diagnosis, monitoring, or treatment of a serious disease or condition[2] must make available such company’s […]

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NICE

The Good, the Bad and the Unresolved: Proposed Changes to the UK Market Access for Medicines

In October 2016, the National institute for Health and Care Excellence (NICE) and National Health Service England (NHS England) launched a 12 week consultation on proposed changes to the arrangements for evaluating and funding drugs and other health technologies appraised through NICE’s Technology Appraisal (TA) and Highly Specialised Technologies (HST) programmes. The consultation closed on […]

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Office of Inspector General, U.S. Department of Health and Human Services.  (PRNewsFoto/Office of Inspector General Department of Health and Human Services)

HHS OIG Publishes Final Rule on Anti-Kickback Statute: Safe Harbors And Monetary Penalties

On December 6, 2016 the U.S. Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued two final rules relating to the Anti-Kickback Statute (AKS) and Civil Monetary Penalties (CMP). These rules affect a wide variety of health care companies and also impact False Claims Act investigations and litigation. The first rule “amends […]

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