Draft - Regulatory & Compliance

Supporting product development, market access and ongoing compliance.

Overview

Life Sciences organisations operate within one of Australia's most heavily regulated industries. From product development and market entry through to commercialisation and post-market compliance, regulatory obligations play a critical role throughout the product lifecycle.

We advise pharmaceutical companies, biotechnology businesses, medical device manufacturers and healthcare organisations on the legal and regulatory issues that arise when bringing products to market and maintaining compliance in an evolving regulatory environment.

Clayton Utz has incredible depth and experience which is hard to find.

– Chambers Asia Pacific, Life Sciences

The TGA administers the Therapeutic Goods Act and related regulations to ensure the safety, efficacy, performance and quality of therapeutic goods in Australia. We advise clients on a broad range of TGA-related matters, including:

Product classification and regulatory strategy (including in relation to products which may be on the boundary of or need to comply with more than one type of regulated product e.g. cosmetics and therapeutic goods, therapeutic goods and consumer electrical products)
Product registrations and listings (including challenge to negative outcomes)
Medical device regulation (including Essential Principles and conformity assessment procedures)
Advertising and promotional compliance
Product recalls and corrective actions
Regulatory investigations and enforcement action

Many pharmaceutical companies will seek to list their pharmaceutical products on the PBS, which facilitates the supply of Government-subsidised drugs and medicinal products. Australia's pricing and reimbursement framework is highly complex. There are also other reimbursement avenues which may be relevant to a particular therapeutic good or related service (such as the Prescribed List, or the Medicare Benefits Scheme).

We assist clients with:

Market access considerations
PBS-related legal issues
Pricing and reimbursement matters
Government engagement and strategy

We help pharmaceutical companies navigate their obligations under the Medicines Australia Code or Medical Technology Code, including

Promotional and advertising reviews, including complaints made to the industry body committee
Review of proposed stakeholder engagement, including with healthcare professionals and health consumer organisations
Applying the Code to patient support programs
Advising member companies with respect to their transparency commitments and obligations
Compliance reviews and investigations