The Department of Health in October 2014 announced that an independent review was to be conducted on the regulation of medicines and medical devices. The main idea was to streamline the regulatory process for a timely access of goods by the Australian public. This review was to consist of

  1. First report on prescription and OTC medicines, and medical devices
  2. Second report on complementary medicines

On 31st March 2015, the Government was provided with the first report. In summary, the panel made recommendations to expand avenues for approval by creating provisions to utilise assessments conducted by comparable overseas regulating bodies – and by setting conditions to identify which bodies can be considered comparable; accelerated assessments for defined circumstances; enhancing and streamlining post-market requirements for goods on ARTG; and improving transparency and predictability of TGA’s processes and decisions so that Australians have timely access to quality, safe and efficacious products. In essence, it recommended improving and reducing regulatory framework red tape.

While the review seems to support growth of pharmaceutical industry, not everybody seems to approve of these recommendations. For example, the Royal Australian and New Zealand College of Psychiatrists (RANZCP) responded with concerns that some recommendations in the review prioritises deregulation over the government’s commitment to providing the highest standards of safe, reliable and quality products. The RANZCP’s views were that TGA’s rigorous processes were necessary to ensure consumers’ healthcare, wellbeing and safety. It particularly took a stance against the principle that the TGA should not impose any additional requirements if international regulators like FDA and EMA had already approved a medicine. RANZCP is of the opinion that these bodies, although reputed, do not have unblemished track records and it cannot be assumed that they will not make errors in the future.

What is your opinion on this subject – do you think that the TGA should accept international regulatory bodies such as FDA & EMA’s assessments with no further ‘red tape’ or should we have our own independent assessment?

 

References:

  1. Health.gov.au. (2016). Department of Health | Expert Review of Medicines and Medical Devices Regulation. [online] Available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/Expert-Review-of-Medicines-and-Medical-Devices-Regulation [Accessed 10 Sep. 2016].
  2. Health.gov.au. (2016). Department of Health – Expert Panel to Review Medicines and Medical Devices Regulation. [online] Available at: http://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2014-dutton091.htm [Accessed 10 Sep. 2016].
  3. Ranzcp.org. (2016). [online] Available at: https://www.ranzcp.org/Files/Resources/Submissions/Department-of-Health-Review-of-Medicines-and-Medic.aspx [Accessed 10 Sep. 2016].
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