Compliance Resources to Help you Stay Current

The Thailand Corporate Governance code was published by the Stock Exchange of Thailand. It was revised in 2006 and this article gives a brief overview and summary of requirements included in the code.

The Hong Kong Corporate Governance code was published by the Stock Exchange of Hong Kong. The code was revised in 2012 and this article gives a brief overview and summary of requirements included in the code.

The New Zealand Securities Commission published “Corporate Governance in New Zealand Principles and Guidelines” in February 2004. The aim of these principles is to make sure that companies in the country are run in an ethical and compliant manner. This article provides a summary of the requirements included in this document.

The Monetary Authority of Singapore’s Risk Management Practices Guidelines dealing with internal controls makes it clear that a financial institution’s Board and senior management must establish processes, policies and procedures ensure its compliance with regulatory requirements. These policies and processes should also make sure that the institution’s operations are effective and compliant.

The new draft EU regulation on information accompanying transfer of funds was published in February 2012. It provides information about rules to be followed by the payer and the payee involved in transfers of funds so as to detect and deter crimes money laundering and terrorist financing. The new regulation is based to a large extent on the recommendations made by the Financial Action Task Force (FATF) and aims to improve traceability of payments and to ensure that the EU framework remains fully compliant with international standards.

The 2012 Singapore Corporate Governance Code supersedes and replaces the Code that was issued in July 2005. The Code is now under the purview of the Monetary Authority of Singapore (MAS) and Singapore Exchange (SGX). This article provides a brief overview and summary of the Code’s key requirements.

The new draft EU Directive published in February 2013 aims to improve the EU's existing rules on anti-money laundering and reinforce vigilance by covered entities so as to deter crimes and corruption. The Directive also considers the recommendations of the Financial Action Task Force (FATF), the world anti-money laundering body, and follows rules sanctioned by competent authorities.

New Zealand established these risk management program requirements for non-bank deposit takers under 157M of the Reserve Bank Act 1989. This article gives an overview and summary of its key requirements.

The Anti-Money Laundering and Countering Financing of Terrorism Act 2009 (AML/CFT Act) in New Zealand requires that organizations carry out customer due diligence on anonymous accounts, collect relevant customer data and further streamline annual reporting requirements so as to deter such crimes. It applies to financial institutions, casinos and any other person required by any other Act to comply with the legislation. 

ISO 22301 is an international ISO standard that specifies requirements for the setting up of and management of an effective Business Continuity Management System (BCMS).

This article discusses the applicability of the standard, the model its based on and summarizes its key requirements.

OCEG (www.oceg.org) is now partnering with the training branch of QCC Information Security to bring GRC training to the United Kingdom. Beginning in October, QCC will present the OCEG GRC Fundamentals curriculum in a three day small group seminar format, which provides attendees with the knowledge necessary to efficiently design and enhance GRC activities across an organization based on established GRC standards. Through lectures and practical group interaction, discussions, and exercises, attendees learn about defining a GRC strategy, building and enhancing corporate ethics and compliance programs, strengthening core business processes, and improving use of technology to support the integrated governance, management and assurance of performance, risk and compliance. This seminar will prepare you to obtain the GRC Professional (GRCP) certification offered by OCEG's afflilate organization, GRC Certify. To see the training schedule, please click on this link: http://grc-training.com/courses/certified-grc-professional/

The FDA, which regulates dietary supplement products and their ingredients, recently warned manufacturers of dietary supplements containing DMAA (1, 3-dimethylamylamine) for not providing evidence regarding safety of their products. The Agency thus deemed the products as 'adulterated' (as DMAA is known to cause serious side-effects) and sent warning letters to 10 manufacturing firms for failing to demonstrate the safety of their products.

On May 10 2012, the FDA released new draft guidance on "Paediatric Information for X-ray Imaging Device Premarket Notifications". This new guidance provides health professionals with guidelines enabling them to use the imaging equipment already in use at their facilities safely on paediatric patients. This guidance applies only to complete x-ray imaging devices that could be used on paediatric patients.

GSK’s new medicine for treating Lupus – Benlysta (generically known as ‘Belimubab’) was rejected by the UK National Health Service’s (NHS) drug rationing body. The drug was discovered by Human Genome Sciences and developed by Glaxo SmithKline (GSK) to combat the disease that causes the immune system to attack joints and organs. This article details why the drug was rejected and outlines the NHS drug approval process.

Non-prescription (OTC) drugs marketed without an approved application are also subject to adverse event reporting requirements, under section 760 of the Federal Food, Drug, and Cosmetic Act. A report of each adverse drug experience which is both serious and unexpected must be made to the Agency, as soon as possible, but no later than 15 days, after receiving information about the event.

An original drug manufacturer seeking new drug approval from the FDA is responsible for accurately and adequately labeling the new drug. A manufacturer of a generic drug is only responsible for making sure its warning label is the same as the reference drug. This has led to an outcry from patients and drug manufacturers as generics makers cannot be held legally responsible for any product defects. Both groups are demanding a change in current generics warning label regulations by the FDA.

Drug shortage in the US is going global, as the pharmaceutical industry is increasingly globalised, shortages in one country will affect others. In 2011, according to FDA, as many as 250 drug shortages have been traced, and a total of 195 drug shortages were prevented, as the Agency has taken proactive steps needed to increase available supply for patients in the U.S.

On Feb 28 2012, the FDA released new draft guidance on safety changes for widely used cholesterol – lowering or statin drugs. These regulations aim to educate, update health care professionals and patients about the health benefits as well as risks associated with these drugs.

On February 9, 2012, the FDA released draft guidelines about quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and are based on key scientific and regulatory factors which should be considered for submission of applications for bio-similar products to the FDA.

On February 9, 2012, the U.S FDA released draft guidelines about scientific and quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and provide an overview of FDA’s approach in determining bio-similarity of a biologic product.