This article was written by Mark Weber and Suman Reddy.

On 15 September 2016, the Department of Health released its response to an independent review of medicines and medical device regulations (Sansom Review). The accepted recommendations resulted in the Government committing to 7 “work packages” intended to make the process of bringing new therapies to market quicker and easier for sponsors; resulting in obvious benefits for consumers.

The work packages will be progressed and implemented by the Department over the course of the next 10 to 24 months, and focus on the following objectives:

  • increasing the use of overseas assessments with comparable regulators, while maintaining sovereignty of regulatory decisions;
  • increasing flexibility in pre-market assessment processes for medicines and medical devices, including expedited and provisional approval and allowing the operation of commercial assessment bodies in Australia for medical device assessments;
  • taking a risk-based approach to variations to medicines and medical devices and access to products not listed in the Australian Register of Therapeutic Goods (ARTG);
  • enhancing post-market monitoring and improving integration of administrative arrangements relating to pre- and post-market processes for subsidy and other purposes;
  • simplifying processes by which advertising of therapeutic products to the public is regulated;
  • working across government to consider incentives for innovation to improve the competitiveness of the Australian complementary medicines industry and increasing information available to consumers; and
  • conducting further reviews on the Scheduling Policy Framework for substances in consultation with states and territories and on the appropriateness of the application of the therapeutic goods regime to a range of low-risk products.

The TGA will release a series of consultation documents in order to progress these work packages, with the schedule for release of documents announced on 31 October 2016.

TGA schedule for consultation on medical device reforms

The TGA has published a schedule of 16 consultations inviting stakeholder comments on the Sansom Review, with two being released immediately. Consultations will only be open for a 6 week period, and due to the tight program design for the reforms and various anticipated amendments, the 6 week period is unlikely to be extended.

Consultation

Timeframe for release of consultation document

Prescription medicine regulatory reforms

Criteria for comparable overseas regulators - enhanced international collaboration in the regulation of prescription medicines

October 2016

Expedited pathways for prescription medicines eligibility criteria and designation process

October 2016

Provisional approval - registration process and post-market requirements

February 2017

Enhancements to TGA's post-market monitoring scheme for medicines

February 2017

Simplifying regulatory arrangements for advertising of medicines and medical devices

Consultation on options for handling complaints about therapeutic goods advertising and timing of other changes to the advertising framework

November 2016

Medical device regulatory reforms

Designation of Australian conformity assessment bodies for medical devices

November 2016

Accelerated assessment of medical devices - priority review

November 2016

Use of overseas regulatory approvals for medical devices and criteria for identifying comparable overseas designating authorities and regulators

February 2017

Complementary medicine regulatory reforms

Introduction of a new class of assessed complementary medicines

January 2017

Mechanisms for establishing a list of permitted indications including the criteria for what a permitted indication is and the initial lists of permitted indications

January 2017

Appropriate criteria for publication of claims on promotional material for complementary medicines

January 2017

Incentives for encouraging innovation in the complementary medicines sector

March 2017

Streamlined regulation of patient-specific access to therapeutic products

Consult on criteria for unapproved products of acceptable risk to be notified to TGA via and SAS Cat B Scheme

February 2017

Consult with stakeholders to develop a streamlined process for Authorised Prescriber Scheme applications

February 2017

Further reviews

Review of the Scheduling Policy Framework (SPF)

March 2017

Review of low risk products

March 2017

In addition to the above, the TGA has also released consultation papers in relation to Biovigilance responsibilities of sponsors of biologicals and guidance on risk management plans for medicines and biologicals.

Consultations on adoption of EU guidelines by TGA

Further, the TGA has recommended that several European Union guidelines be adopted in Australia. These relate to clinical efficacy and safety guidelines in the clinical investigation and evaluation of medical products including:

  • in patients with decreased renal function;
  • recombinant and human plasma-derived factor VIII products;
  • for the treatment of venous thromboembolic disease;
  • anticancer medicinal products;
  • for the treatment of juvenile idiopathic arthritis;
  • for the treatment of Duchenne and Becker muscular dystrophy;
  • for the treatment of amyotrophic lateral sclerosis (ALS); and
  • for the treatment of asthma,

and guidelines for:

  • epidemiological data on blood transmissible infections; and
  • key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products.

The proposed adoption of these guidelines is indicative of the TGA using EU regulations and guidelines more broadly as a base for its own regulatory activities. Further information about the consultation and the related guidelines can be found here.