Compliance Regulations and Guidance Affecting your Industry

This document provides guidance to non-bank deposit takers in New Zealand in relation to the risk management programme requirements established under section 157M of the Reserve Bank Act 1989. Part 2 of this document notes some considerations in relation to risk management programmes and Part 3 provides some guidelines on how to interpret the main categories of risk set out in section 157M.

These regulations require deposit taking finance companies, building societies and credit unions in New Zealand to maintain a minimum capital ratio, and to limit the amount of credit they can provide to related parties.

This document sets out the methodology to be used by locally incorporated registered banks in New Zealand that have been accredited to use the internal models based approaches to calculating capital ratio requirements. This methodology is to be used for the purposes of determining these banks’ compliance with conditions of registration relating to capital and for disclosing information about capital.

This document sets out the methodology to be used by locally incorporated registered banks in New Zealand that have adopted the standardised approach for calculating capital requirements. This methodology is to be used for the purposes of determining these banks’ compliance with conditions of registration relating to capital and for disclosing information about capital.

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.

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. The FDA recently released new guidance on how manufacturers can notify authorities on impending drug shortages.

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.

On December 27, 2011, the FDA released new draft guidance on 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications. The guidance aims to explain the decision-making process of FDA for determining substantial equivalence and provides additional details about the regulations, strategies, and norms upon which the FDA’s review of the 510(k) application is based. The guidance also provides information about new policies regarding Special 510(k) and Abbreviated 510(k) submissions to FDA.

In Australia, advertisements for therapeutic goods that are directed at consumers should get approved before broadcasting or publication and must comply with Therapeutic Goods Advertising Code.

The latest version is Therapeutic Goods Advertising Code (TGAC) 2007 which took effect on March 8, 2007.
 

Australia’s legal framework to detect and deter money-laundering and terrorism, namely, the Anti-Money Laundering and Counter-Terrorism Financing Act 2006 (AML/CTF Act) lays down the obligations that are supervised and regulated by the Australian Transaction Reports and Analysis Centre (AUSTRAC).

The Financial Services Authority (FSA) is a risk-based regulator and ARROW is the framework it uses to make risk-based regulation operational. ARROW stands for the Advanced, Risk-Responsive Operating Framework and covers all risks, firm-specific, thematic and internal.

'Internal Control: Guidance to Directors' ("the Turnbull guidance") sets out best practice on internal control for UK listed companies, and assists them in applying section C.2 of the UK Corporate Governance Code.

The FDA has issued a draft guidance that aims at increasing the representation of women in medical device clinical trials. Aimed at medical device manufacturers and developers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.

On December 20, 2011, the Federal Reserve proposed new rules that would strengthen regulation and supervision of large US bank holding companies and systemically important nonbank financial firms.

On December 16, 2011, the Environmental Protection Agency (EPA) issued the first ever national standards aimed at reducing the emissions of toxic air pollutants from power plants. The EPA was required by the Clean Air Act of 2000 to formulate and enforce these standards.

The Physician Payment Sunshine Act was passed in 2010 as part of President Barack Obama’s legislative agenda to overhaul healthcare. The Centers for Medicine and Medicaid Services (CMS) was tasked with the drafting of the rules to enforce the Act’s requirements. CMS published its proposed rule in December, 2011.

The Australian Prudential Standard 112 – Capital Adequacy: Standardized Approach to Credit Risk aims at ensuring that “ensure that an authorized deposit-taking institution holds sufficient regulatory capital against credit risk exposures.”

The Australian Prudential Standard 110 – Capital Adequacy aims at ensuring that “authorized deposit-taking institutions maintain adequate capital, on both an individual and group basis, to act as a buffer against the risks associated with their activities.”