Regulatory Standards

News & Analysis as of

UK MHRA to develop quality standards for biological medicines

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines....more

Is the Proposed Safety Fitness Determination Rule in Jeopardy?

The Federal Motor Carrier Safety Administration (FMCSA) published a notice of proposed rulemaking (NPRM) in the Federal Register on Jan. 21, 2016, designed to enhance the agency's ability to identify non-compliant motor...more

New guidance note on reinsurance for Hong Kong insurers

A new guidance note on reinsurance for Hong Kong insurers (“GN17“) came into effect on 1 January 2017. GN17 contains a number of general requirements with regard to the management and monitoring of reinsurance...more

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ? Intent, But Knowledge Certainly Can Be One Element in Establishing the...

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

Carriers Advocate for Data-Driven Regulations

Freight carriers of all modes ­– rail, truck, water, air and pipeline – are all in the business of moving cargo for compensation and thus share many similar goals. Furthermore, cargo is often moved in multiple modes in its...more

New corporate governance requirements in Hong Kong

New corporate governance standards for insurers authorised in Hong Kong came into effect on 1 January 2017. Hong Kong incorporated insurers and overseas insurers with a certain threshold of Hong Kong business must comply with...more

Los contratos gubernamentales promueven cada vez más los objetivos relacionados con las políticas laborales

El año pasado, el gobierno federal implementó varias normas que exigen que sus contratistas cumplan con ciertos requisitos de trabajo justo. Por ejemplo, una norma federal finalizada en el mes de septiembre exige que los...more

U.S. Department of Education Issues New Guidance Interpreting Civil Rights Laws Protecting Students with Disabilities

Regulators have given school districts new guidance on how to remain compliant with federal laws concerning services to students with disabilities thanks to some year-end agency filings. U.S. Department of Education...more

Culture: Meeting Regulatory Expectations

“Culture remains a key driver of significant risks … and the root cause of high-profile and significant failings. Our focus on culture in financial services firms and its impact on conduct has been, and remains, a priority....more

CFPB possibly amenable to changing its prepaid account rule

At a panel discussion today on the prepaid account rule, held as part of the meeting of the American Bar Association Committee on Consumer Financial Services in Carlsbad, CA, Kristine Andreassen, the team leader for the CFPB...more

U.S. District Court Upholds CLO Risk Retention Rule

Investment managers that wish to manage newly formed CLOs will need to have sufficient capital to retain the risk they are required to retain under the Rule. On December 22, 2016, the U.S. District Court for the District...more

New York Department of Financial Services Revises Proposed Cybersecurity Rule

The New York Department of Financial Services (NYDFS) recently issued a revised proposed regulation seeking to add its own mandate of cybersecurity requirements to those already in existence for banks, insurance companies and...more

Managing the Risks and Benefits of an On-Site Automatic Defibrillator Program

Sudden cardiac arrest (“SCA”) is the largest cause of natural death in the United States and is responsible for approximately half of all heart disease deaths. SCA, however, is not a “heart attack” (i.e. an artery blockage)...more

New e-payment licensing regulations in the UAE

On 1 January 2017, the Central Bank of the United Arab Emirates issued the Regulatory Framework For Stored Values and Electronic Payment Systems (Regulations). The overarching goal of the Regulations is to help facilitate the...more

U.S. Access Board Issues Standards for Medical Diagnostic Equipment

Seyfarth Synopsis: Many years in the making, today the Access Board issued design criteria and other standards for medical diagnostic equipment. Today, the U.S. Access Board issued new accessibility standards for medical...more

EMA on optimising the development of advanced therapies

On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory conference concerning the optimisation of the development of...more

UK MHRA publishes “top tips” for manufacturing authorisation applicants

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on common mistakes made by applicants, to help reduce...more

Will the Trump Administration Hit the Brakes on the Speed Limiter Rule?

One controversial rule proposal that many expect will not become final under the new Trump Administration is the Speed Limiter rule proposed by two agencies of the U.S. Department of Transportation (DOT), the National Highway...more

Maine Board of Environmental Protection Unanimously Adopts Metallic Mineral Mining Rules

On January 5th, the Maine Board of Environmental Protection (Board) unanimously voted to repeal existing Chapter 200 Metallic Mineral Exploration, Advanced Exploration and Mining rules and adopt new Chapter 200 rules to...more

State Council Announces Plan for a Pollution Discharge Permit System

China’s State Council released its “Plan for Controlling the Implementation of the Pollution Discharge Permit System,” (the Plan), which establishes guidelines and policy goals for the pollution permitting system being...more

Ontario simplifies approval process surrounding air contaminant emissions

The Ministry of the Environment and Climate Change (“MOECC”) filed the first regulation in Ontario of 2017: Ontario Regulation 1/17 (the “Regulation”). The Regulation simplifies the approval process for certain activities...more

Drones in the UK: summary of government consultation

Ongoing development of UK drone policy has taken a significant step forward with the publication of the "Consultation on the Safe Use of Drones in the UK" issued by UK Department of Transport ("DfT") on 21 December 2016....more

FINRA Fines Firms For Not Supervising L-Share Annuity Sales

For two years FINRA has made sales and marketing of L-Share variable annuities (VAs) a regulatory and examination priority. Not surprisingly, FINRA in November announced settled actions against eight broker-dealers, alleging...more

Spectrum Powering the Internet of Things

Leaders from the public and private sectors recently analyzed the relationship between federal spectrum policy and the Internet of Things (IoT) at the Fifth Annual Winnik International Telecoms and Internet Forum. In a...more

Are you a fan? New Wind Farm Planning Guidelines announced in NSW!

New Wind Energy Guidelines for state significant wind energy developments provide much needed guidance on the regulation of visual and noise impacts for renewable energy developers....more

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